Malaysian Genomics Reports RM28.36 Million Full-Year Revenue

PETALING JAYA, Malaysia, Aug 30, 2022 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad, a leading genomics and biopharmaceutical specialist, reported revenue of RM6.33 million for the fourth quarter ended 30 June 2022 (4Q 2022) compared with the loss of RM0.07 million in the corresponding quarter of the previous financial year (4Q 2021) on higher contribution from the biopharmaceutical business and continued organic growth of the genetic testing business.


Sasha Nordin, Chief Executive Officer of Malaysian Genomics


The Group recorded a profit before tax (PBT) of RM2.97 million for the quarter under review compared with a loss before tax (LBT) of RM2.11 million in 4Q 2021 due to higher profit margin from the biopharmaceutical business as well as efficient cost monitoring.

For the financial year ended 30 June 2022 (FY2022), Malaysian Genomics registered revenue of RM28.36 million, which is an increase of RM26.58 million compared with RM1.78 million reported in the corresponding period of the previous financial year (FY2021) from growth of the biopharmaceutical business comprising of immunotherapy and cell therapies as well as COVID-19-related products and services.

The Group recorded PBT of RM6.18 million for FY2022 compared with LBT of RM4.29 million in FY2021 mainly due to higher revenue as a result of higher margin as well as cost efficiencies.

Earnings per share for 4Q 2022 stood at 3.25 sen compared with the loss per share of 1.94 sen in the corresponding quarter of the previous financial year.

En. Sasha Nordin, Chief Executive Officer of Malaysian Genomics said, "We continue to see improvement in the Group's financial performance, and this is attributable to the introduction of biopharmaceutical services as well as our aggressive push to market genetic testing services. Towards the tail-end of the quarter under review, we acquired a 51% stake in kidney dialysis operator Aquahealth Sdn Bhd in which we intend to introduce a holistic approach to kidney healthcare through our suite of products and services. We also have plans to open more such centres across Malaysia given the projected increase in the number of kidney patients."

"We are also expanding in Southeast Asia and the Middle East with a series of agreements that we recently inked in which we collaborate with local partners to promote, market and distribute our biopharmaceutical and genetic testing services."

About Malaysian Genomics Resource Centre Berhad

Malaysian Genomics Resource Centre Berhad ("Malaysian Genomics" or "the Group") is a leading genomics and biopharmaceutical company based in Southeast Asia. The Group was established in 2004 and listed on the Bursa Malaysia stock exchange in 2010. From pioneering work in genome sequencing, bioinformatics analysis, and genetic screening services, Malaysian Genomics has expanded into the biopharmaceutical sector with the manufacturing of cell therapies including immunotherapy for various types of cancer.

Utilising its high-throughput sequencing lab, advanced microarray facility, and new state-of-the-art cell processing lab, the Group is committed to improving access to the latest in precision and personalised healthcare solutions to improve the lives of patients. For more information, visit www.mgrc.com.my.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Strengthen technological innovation, Basecare Medical Announces 2022 Interim Results

HONG KONG, Aug 29, 2022 – (ACN Newswire) – Suzhou Basecare Medical Corporation Limited ("Basecare Medical" or the "Company", together with its subsidiaries, the "Group", stock code: 2170), an innovative platform of genetic testing solutions for assisted reproduction in China, officially announced the unaudited consolidated interim results for the six months ended June 30, 2022 (the "Reporting Period").

During the Reporting Period, the Group recorded revenue of RMB68.6 million, a year-on-year increase of 36.7% compared to H1 2021. This increase was primarily driven by the revenue related to PGT laboratory increased by 53.4% from RMB26.6 million to RMB40.8 million, and the revenue increased from nil to RMB354,000 related to the male-focused laboratory, mainly contributable to the sales of the flow cytometer. The gross profit margin was outstanding during the Reporting Period. The gross profit of the Group increased by 36.0% to RMB30.2 million for the six months ended June 30, 2022, with a gross profit margin of 67.9% from PGT-A. Basecare Medical has transformed from a single product company to a comprehensive scenario solutions provider in the assisted reproduction industry, providing multi-scenario solutions including PGT laboratory-related solutions, male-focused laboratory-related solutions, and cryopreservation room-related solutions. Through a parallel business model consisting of both R&D and marketing, Basecare Medical has built a closed-loop business chain based on actual clinical needs, providing custom-made scenario solutions for customers, resulting in better customer satisfaction.

Focus on technological innovation to satisfy the evolving needs of the assisted reproductive market

By adhering to the "well-crafted product" concept, Basecare Medical's R&D expenses increased significantly by 99.5% year-on-year to RMB45.5 million during the Reporting Period. Basecare Medical has established a complete series of testing kits in the pipeline of genetic testing kits, which is based on next-generation sequencing (NGS) technology. Meanwhile, the PGT-A kit from Basecare Medical is China's first third-generation IVF genetic testing kit approved by the National Medical Products Administration (NMPA). The sales revenue of PGT-A kits was RMB16.4 million, with a gross profit margin of 67.9%. Meanwhile, the other two PGT products, PGT-M and PGT-SR kits are also under development. The PGT-M kit is the first and only product of its kind in China that has completed the registration test, and the PGT-SR kit is the world's first original technology to achieve effective testing of chromosomal balanced translocations through the high-throughput sequencing platform, which obtained the national invention patent technology and may become the first standardized commercial product in this series of products in China with the potential for mass clinical application. After the PGT-M and PGT-SR kits are approved for registration by the NMPA, respectively, Basecare Medical expects to further consolidate its dominant position in the third-generation IVF genetic test kit market in China, well ahead of the Company's competitors in the potential competition.

Beyond test kits, Basecare Medical has developed a number of innovative devices and instruments that can improve workflow in molecular genetic laboratories using its kits, as well as the industrial chain layout of embryo cryopreservation equipment, and has provided intelligent and automated integrated solutions for clinical trials to improve the Company's competitiveness.

R&D and marketing develop synergistically, the commercialization process shows a steady upward trend

Although a significant portion of products was directly sold to hospitals and testing institutions, Basecare Medical also sold testing kits to distributors, who in turn sold the Company's products to hospitals. With an outstanding marketing team, Basecare Medical provides services to key customers such as third-generation IVF licensed hospitals and testing institutions, which are a major component of the Company's customers. The Company's marketing team is also responsible for promoting products to hospitals through academic marketing activities and interactions with KOLs and other industry professionals. At present, Basecare Medical has collaborated with over 200 medical institutions across the PRC, including 60 leading reproductive centers.

With the first NMPA-approved PGT kit in China, Basecare Medical enjoys first-mover advantages in building and solidifying its sales channels and customer base. Basecare Medical plans to focus its commercialization strategy on key hospitals. The Company will increase the coverage and penetration of hospitals licensed to conduct PGT and develop stronger relationships with them to enhance customer stickiness and lay the foundation to offer other products to them in the future. Moreover, Basecare Medical plans to expand the share of wallet in these hospitals by offering comprehensive solutions, as well as offering new products for meeting other medical needs in these institutions.

Occupy the full reproductive cycle and be a leading global medical technology company

To accomplish the vision of becoming a leading global medical technology company, Basecare Medical will continue to capture and solidify PGT-A's sales channels and maintain the established customer relationships while accelerating the clinical registration process of PGT-M and PGT-SR kits, to rapidly establish a comprehensive product pipeline of the third-generation assisted reproduction to occupy the full reproductive cycle. Regarding the instrument pipeline, Basecare Medical intends to develop automated and intelligent hardware to upgrade the industry infrastructure and maintain technological leadership by leveraging the advancements of global leaders.

It is expected that a peak in the approval and delivery of the Company's products and pipeline will be achieved in the coming two to three years. Basecare Medical will satisfy the evolving needs of the assisted reproductive market, further develop scenario solutions in assisted reproduction to better serve the infertile and eugenic public, and create more value for customers.

About Suzhou Basecare Medical Corporation Limited

Suzhou Basecare Medical Corporation Limited is a third-generation IVF clinical solution provider in China and the first listed IVD company in the field of assisted reproduction (stock code: 2170.HK). It is committed to the product R&D and clinical application of gene technology in the field of reproductive health. Basecare Medical has been adhering to the "well-crafted product" concept, adhering to the industrialization road of independent R&D and localization substitution, and has built multi-scenario solutions for assisted reproduction covering PGT laboratories, andrology laboratories, and frozen storage rooms. The PGT-A (pre-implantation chromosome aneuploidy testing) kit, a class III medical device product independently developed by the company, has won China's first "special approval for innovative medical devices", filling the clinical gap of third-generation IVF genetic testing kits in China.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Sponsors Biotech Company of the Year Awards at Informa Pharma Intelligence Awards 2022

ADELAIDE, AUS, Aug 29, 2022 – (ACN Newswire) – Avance Clinical, the leading Australian CRO for international biotechs, is sponsoring two awards – Biotech Company of the Year Private and Public – at the Informa Pharma Intelligence Awards 2022 and is also a finalist for the Best Contract Research Organization in APAC.



The Biotech Company of the Year awards recognize achievements including "moving the business from an early stage to a more mature company, signing a transformative deal, taking its first or a major new product towards the market, or raising significant new funds".

CEO Yvonne Lungershausen and Chief Strategy Officer Ben Edwards are attending the awards night and hosting a table for biotech clients in Japan next week.

Avance Clinical, which is backed by global private equity firm The Riverside Company, is in the process of regional and international expansion plans.

Along with Avance Clinical, the finalists for the Best Contract Research Organization APAC are:
– Calyx
– CMIC Group
– EPS
– ICON
– Parexel
– Syneos Health

Avance Clinical's CEO Yvonne Lungershausen said: "Avance Clinical is extremely pleased to be sponsoring these biotech awards. We are the CRO for international biotechs and this collaboration with Informa Pharma Intelligence shows our ongoing support and investment for the biotech industry."

The finalists for Biotech Company of the Year – Private:
– ARTham Therapeutics
– Chordia Therapeutics
– Cuorips
– Heartseed
– Prism BioLab
– Rebirthel
– ReboRNA Biosciences
– TMS

The finalists for Biotech Company of the Year – Public:
– NanoCarrier
– Rakuten Medical (Rakuten Group Inc.'s equity accounted affiliate)
– Sosei Heptares
– Stella Pharma
– StemCell Institute

"In addition, we are extremely honored to be selected as a finalist for the prestigious award Best Contract Research Organization in APAC. It is a credit to our customer-focused team for delivering world-leading CRO services for biotechs which has been recognized by the Informa Pharma Intelligence award judges. Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients. We are very proud of our growth and success in recent years."

According to Informa Pharma Intelligence, this Award is to recognize CROs that provide full or specialist services to their clients and which have an office in either in Japan or the Asia region including Australia. Judging considers the quality of services and relationships built with clients and pays particular attention to the innovative patient recruitment strategies the CRO has brought to the table. The award is based on achievements in the 2021 calendar year.

Core areas judged include:
– The particular capabilities and strengths the CRO offers
– How the company has delivered results that exceed sponsor expectations
– Innovations in patient recruitment strategy has the CRO brought to its partner
– How it has improved its performance, for example, in its quality of data, timelines and transparency
– The steps the company is taking towards streamlining data collection and reporting

To find out more please visit: https://pharmaintelligence.informa.com/events/awards/japan-awards-2022/shortlist-2022

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry. The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

"We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector," said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:
– Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
– Read more about Avance Clinical's cell and gene therapy capabilities here www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/
– For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Malaysian Genomics Signs MoU with Ajlan to explore distribution of biopharmaceutical and genetic screening services in MENA region

PETALING JAYA, Malaysia, Aug 29, 2022 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, today announced that the Group has signed a Memorandum of Understanding (MoU) to explore opportunities for the distribution of biopharmaceutical and genomics products and services with Ajlan & Bros Medical Company.


Noor Azri Bin Dato' Sri Noor Azerai, Executive Director of Malaysian Genomics, and H.E. Eng. Ali AlHazmi, Group Chief Executive Officer of Ajlan & Bros Holding Group [L-R]


Ajlan, based in Riyadh, Saudi Arabia, is part of a multinational conglomerate established in 1979 with extensive global private equity, real estate and industrial investments.

As part of the MoU, the parties will explore the feasibility of Ajlan becoming a marketing and distribution representative for Malaysian Genomics for genetic screening tests, mesenchymal stem cell and exosome products. Ajlan will also identify commercial research and development (R&D) opportunities for genome sequencing and analysis in the Middle East and North Africa (MENA) region for areas such as agriculture, aquaculture, plantations, healthcare and industrial biotechnology.

Malaysian Genomics on its part will analyse samples for genetic screening tests as well as provide Ajlan with genomic and bioinformatics expertise to bid for projects through Ajlan.

Noor Azri Bin Dato' Sri Noor Azerai, Executive Director of Malaysian Genomics, said, "This is a really good opportunity for us to explore the MENA market for our products and services, especially in the area of R&D where we see a lot of growth especially in agriculture and aquaculture due to climate change impact and the health diagnosis for distinct population groups."

H.E. Eng. Ali AlHazmi, Group Chief Executive Officer of Ajlan & Bros Holding Group, said, "We look forward to working with Malaysian Genomics to bring its biopharmaceutical and genetic services and products to Saudi Arabia, which is a good launchpad to the MENA region. This MoU is just the beginning as we explore how we can work closely together in the coming months."

About Malaysian Genomics Resource Centre Berhad

Malaysian Genomics Resource Centre Berhad ("Malaysian Genomics" or "the Group") is a leading genomics and biopharmaceutical company based in Southeast Asia. The Group was established in 2004 and listed on the Bursa Malaysia stock exchange in 2010. From pioneering work in genome sequencing, bioinformatics analysis, and genetic screening services, Malaysian Genomics has expanded into the biopharmaceutical sector with the manufacturing of cell therapies including immunotherapy for various types of cancer.

Utilising its high-throughput sequencing lab, advanced microarray facility, and new state-of-the-art cell processing lab, the Group is committed to improving access to the latest in precision and personalised healthcare solutions to improve the lives of patients. For more information, visit www.mgrc.com.my.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

CMS Releases Its 2022 Interim Report, Achieves Sustained Growth with Its Platform Strategy

SHENZHEN, CHINA, Aug 26, 2022 – (ACN Newswire) – China Medical System Holdings Limited (“CMS”, 867.HK) released its 2022 interim report on August 22. In the first half of 2022, CMS delivered an outstanding interim results — it achieved stable performance growth in several business segments, and solid progress in clinical development and registration of innovative products in China, and launched Southeast Asia business to empower its long-term development.

According to CMS’ 2022 interim report, the turnover was RMB4,447.8 million (H1 2021: RMB3,843.0 million), representing an increase of 15.7% over the same period last year; in the case that all medicines were directly sold by the Group, the turnover would increase by 21.1% to RMB5,170.0 million (H1 2021: RMB4,269.3 million). Profit for the period was RMB1,796.3 million (H1 2021: RMB1,631.6 million), representing an increase of 10.1% over the same period last year. CMS’s turnover and profit for the previous ten interim periods have maintained a sound growth momentum with both CAGR exceeding 20%.

Rooted deeply in pharmaceutical industry, the Group has developed a product portfolio covering cardio-cerebrovascular, gastroenterology, central nervous system, dermatology medical aesthetics, ophthalmology, pediatrics and other specialty therapeutic fields. With leading drugs commercialization capability in China, CMS achieved excellent financial performance and initiated its unique “collaborative R&D and investment” innovative R&D strategy. The year of 2022 marks the 30th anniversary of CMS’s establishment. As a mature pharma, CMS has maintained steady growth momentum, and has continuously expanded its business boundary with platform strategy. The 2022 interim report shows the future growth potential of CMS.

Commercialization platform: enabling steady growth of “Cardio-cerebrovascular and Gastroenterology” business and rapid development of emerging business, “ophthalmology” and “dermatology and medical aesthetic”.

The commercialization capability is the core competitive advantage of CMS and the cornerstone of its continuous growth. The Group’s marketed product lines, including cardio-cerebrovascular, gastroenterology, ophthalmology, dermatology and medical aesthetic line, all achieved steady growth in the first half of 2022. Among which, cardio-cerebrovascular and gastroenterology lines, CMS’s traditional business, increased by 26.0% and 17.4% respectively year-on-year. The core products have maintained strong growth momentum after being commercialized for years, and several products have ranked first among peers, which is rare and it highlights the value of CMS’s commercialization platform.

As the core emerging strategy of CMS in recent years, the “ophthalmology” and “dermatology and medical aesthetic” businesses, with product matrix being expanded while business system getting shaped, have both achieved steady growth by leveraging the Group’s commercialization capability.

In particular, CMS has been engaged in the ophthalmology field for many years. Both its core product Augentropfen Stulln Mono Eye drops and innovative pipeline Cyclosporine Eye Drops 0.09% have attracted considerable attention. In July 2022, the Group acquired the global assets related to VEGF/ANG2 tetravalent bispecific antibody from Wuhan YZY Biopharma Co., Ltd, which further enriched its innovative pipeline in the ocular fundus diseases treatment field; In August, the Group entered into an agreement with EYE TECH CARE (“ETC”), a medical company of France, for the EyeOP1 ultrasound glaucoma treatment device and made an equity investment to acquire approximately 33.4% equity interest in ETC. CMS’s ophthalmology product matrix has expanded from prescription medicine to devices and consumables through this collaboration, while CMS’s academic platform and channel resources accumulated over years in the ophthalmology field will provide a solid foundation for the rapid development of new products. Based on this, CMS has built a clearer development path for its ophthalmology business that featured with high-growth potentiality.

For the dermatology and medical aesthetics business, since the Group promoted its independent operation in 2021, the Group has acquired several medical aesthetics specialty companies and multiple marketed products with professional brands in the field, which have accelerated its development in the dermatology prescription and medical aesthetic fields. The focused ultrasound technology R&D platform of CMS, is developing three major series of products, including FUBA Focused Ultrasound Fat Reduction Device Series, LITU Focused Ultrasound Skin Treatment Series, and MEBA Ultrasonic Transdermal Delivery Series, to further expand its energy-based medical aesthetic devices product portfolio. In August 2022, CMS acquired 60% equity interest in Heling Medical, and entered into an exclusive license agreement for three dermatology-grade skincare products. Heling will act as the Group’s R&D platform for dermatology-grade skincare products and accelerate the category expansion and product iteration for CMS. With the operation system of “CMS Aesthetics” getting shaped and the continuous acquisition of new products, CMS is steadily moving forward with its professional operation, compliance management and resource advantages in this rapidly developing and gradually regulated medical aesthetic market.

Innovation platform: “collaborative R&D and investment” strategy broadened its innovation development potential

With commercialization capability being its foundation of innovative R&D, CMS has developed its innovative strategy — “collaborative R&D and investment” that could best leverage its strengths and capabilities. Capitalizing on its strong commercialization gene, extensive academic resources, as well as deep market understanding, CMS is able to identify unmet clinical needs with a sharp business insight, and locate differentiated innovative products with both social and economic value through precise product evaluation.

Nowadays, relying on its increasingly matured innovative R&D team and project management system, while constantly acquiring mature innovative products, CMS also collaborated with biotech companies with innovative technology platforms, to jointly develop innovative products, which could make the most of respective strengths and improve the R&D efficiency by shortening the R&D cycle and reducing expenses. Meanwhile, with its improving scientific mindset and R&D capabilities, the Group actively participated in the target selection and development path planning of innovative products, to conduct customized development of innovative products. Through multi-dimensional collaborative development models, CMS has formed an “innovative product incubation platform” empowering the development of innovative clinical practice in the world.

At present, CMS has acquired nearly 30 innovative products, mainly first-or best-in-class products, among which 9 products have been approved for marketing in the U.S./Europe. During the Reporting Period, 3 products of CMS were under NDA review in China, 1 product was approved for marketing in Hong Kong of China, 1 product’s NDA was granted the priority review designation by the CDE, and 3 products’ China bridging trials were progressing steadily after the completion of first subject dosing. CMS’s innovation development is expected to enter a maturing phase and delivering harvest.

Relying on its innovation transformation platform, CMS is capable to manage the R&D processes and rapidly promote the clinical trial progress. The Group has submitted NDA of several innovative products, including Tildrakizumab Solution for Injection and Methotrexate pre-filled injection in China, which only took 1-2 years since acquisition. In July 2022, CMS has overcome challenges under pandemic prevention and control, and took only 6 months (including the Chinese Spring Festival) to complete the enrollment of all 1,800 subjects in China bridging trial of Methylthioninium Chloride Enteric-coated Sustained-release Tablets. It took only 2.5 months (including the Spring Festival) to complete the enrollment of all 220 subjects in the China bridging trial of Tildrakizumab previously.

With its platform getting increasingly matured, CMS is expected to benefit from the multiplier effect the platform provides and enhance its future scalability.

Southeast Asia Platform: A one-stop operating platform empowers global pharmaceutical companies to enter Southeast Asia market

CMS 2022 interim report indicated it has achieved impressive progresses in the Southeast Asia market.

With the rapid development of China bio-pharmaceutical industry, increased industrial scale and enhanced drugs quality and scientific research level, Chinese pharmaceutical companies have gained stronger competitiveness in the global market, which has presented a critical opportunity for Chinese pharmaceutical companies to develop overseas market. Compared to the United States, Europe, and Japan market with mature pharmaceutical system, Southeast Asia and other emerging markets have greater unmet pharmaceutical demands and provide more opportunities. Pharmaceutical industry trends in the past two years indicates that the Southeast Asia market has drawn great attention and the connection between China innovative drug industry and Southeast Asia market has been getting stronger. At this point, CMS stands out with comprehensive Southeast Asia business development strategy.

Given the information in its 2022 interim report, CMS Southeast Asia business has achieved preliminary results. It has set up an independent operating entity with clear organizational structure, and has built a core team for its business in Southeast Asia, CMS aimed to form a platform covers innovative R&D, production and sales, helping Biotech and pharmaceutical companies in Europe, America, Japan, and China to rapidly enter the Southeast Asia market and achieve mutual beneficial cooperation and strategic complementarity.

In terms of products, CMS newly acquired the innovative EyeOP1 Glaucoma Treatment Device in August 2022, which has been approved for marketing in Southeast Asia. At the same time, CMS’s Southeast Asia business entity has obtained exclusive rights for several insulin products in 11 countries in Southeast Asia, which is an initiative for insulin products of mainland China to enter the Southeast Asia market. As a rigid demand for diabetes, this product series has the advantages of excellent quality and affordable price. In Southeast Asia market, the major insulin products are European and American imported products with high price and the penetration of insulin products is significantly insufficient, which indicates a huge market potential.

The platform in Southeast Asia market is bound to become an important engine driving CMS’s future development.

Conclusion

Platform building requires a solid foundation, but the potential of the platform is unlimited. As a “Platform Company”, CMS will leverage its accumulated advantages to continuously optimize it platform, thus laying a solid foundation for its high growth and business sustainability.

As of now, CMS ‘s PE-TTM is trading only 7.2 times, and its TTM dividend yield reaches 5.5%. Given its growth potential, steady operation, organized development strategy, combined with the strong resilience of the pharmaceutical and medical aesthetic industries, CMS can achieve ” Davis Double Strike ” is worth looking forward to.

Media Contact
Media Team, CMS
Email: ir@cms.net.cn
Website: http://www.cms.net.cn/

Source: China Medical System Holdings Ltd.



Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Zhaoke Ophthalmology Announces 2022 Interim Results

HONG KONG, Aug 24, 2022 – (ACN Newswire) – Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company", SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its interim results for the six months ended 30 June 2022 ("Reporting Period").

Zhaoke Ophthalmology is strategically focused on treatments that cover a wide range of ophthalmic diseases, with one of the largest and most comprehensive drug portfolios of innovative and generic treatments covering the six major eye diseases across both the front-and back-of-the-eye, including dry eye disease ("DED"), myopia, presbyopia, wet age-related macular degeneration ("wAMD"), diabetic macular edema ("DME") and glaucoma. The Company's portfolio includes several potential blockbuster innovative drug candidates.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "Innovation and commercialization are Zhaoke Ophthalmology's dual focuses for 2022. We are proud to say that in the first half of 2022, we accomplished multiple milestone achievements in both areas, despite the challenging environment in China and globally."

The first highlight has been the completion of patient recruitment for concurrent Phase III clinical trials for one of the Company's core innovative drug candidates, NVK002, significantly ahead of schedule. In July 2022, NVK002, a treatment for myopia progression in children and adolescents, completed the recruitment for its concurrent two-year Phase III clinical trial ("China CHAMP") and one-year Phase III bridging trial ("Mini-CHAMP"). The China CHAMP trial involves 19 centers and 770 patients, and the Mini-CHAMP involves 18 centers and 526 patients. The former completed enrolment on 21 July 2022, two months ahead of schedule, while the latter completed enrolment on 28 July 2022, three months ahead of schedule.

Dr. Li continued, "Completing patient recruitment for these clinical trials so far ahead of schedule reflects both the strong capabilities and expertise of Zhaoke Ophthalmology's clinical operations team, as well as the immense demand for a safe and efficacious treatment for myopia progression in China."

The second highlight is the launch of Zhaoke Ophthalmology's first commercialized product, "Baodeshi" the Heat Compress Eyepatch, a category 2 medical device for reducing symptoms of mild cases of dry eye. The Eyepatch launch, will accelerate the Company's efforts to establish an omnichannel commercial strategy

Dr. Li added, "We are excited about the recent launch of the "Baodeshi" Heat Compress Eyepatch with an official flagship store on Tmall. The launch of the eyepatch exemplifies our core belief that a combination of drug regimen therapy and medical device will ultimately deliver the best treatment options for many patients. Moreover, the eyepatch also helps to increase the general public's awareness and knowledge of eye diseases and treatment solutions in China."

During the Reporting period, Zhaoke Ophthalmology achieved several milestones across its comprehensive drug pipeline. The Company's self-developed innovative drug, CsA Ophthalmic Gel for DED, submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The submission was accepted in June 2022 and is now under review by the CDE. In May 2022, Zhaoke Ophthalmology announced a new partnership with Visus, a US pharmaceutical company, to license BRIMOCHOL(TM) PF and Carbachol PF, innovative drugs for presbyopia. The introduction of the two innovative assets enabled Zhaoke Ophthalmology to become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front-of-the-eye diseases – dry eye, myopia, and presbyopia. Also, TAB014, the company's first drug for the treatment of back-of-the-eye diseases, initiated a Phase III clinical trial and the first patient was enrolled for wAMD in June 2022.

Zhaoke Ophthalmology continues to focus on enhancing the Company's innovative omni-channel strategy through expanding its partnership network and strengthening digital engagement The strategy was kick-started with the launch of the Zhaoke Boshi WeChat platform in September 2021, in response to the demand from the ophthalmologist community for high quality content focusing on cutting-edge ophthalmology research in China and globally. This platform not only showcases outstanding content, but also allows leading KOLs to share their knowledge and best practices and facilitates discussions in the Chinese ophthalmologist community. Less than a year after its launch, the Zhaoke Boshi platform has attracted close to 10,000 followers. At the same time, over 60 leading KOLs in various fields of ophthalmology have contributed content or participated in livestream discussions on the platform.

Following the momentum established by Zhaoke Boshi, the launch of "Baodeshi" Heat compress eyepatch on Tmall with its own flagship store, marks the next milestone in our omni-channel commercialization strategy by establishing a direct channel of interaction with dry eye patients and eye-health-conscious consumers alike.

In February 2022, the Company established a corporate gift agreement with John Hopkins University, one of the world's leading private research institutes, to support translational research and academic exchange. In March 2022, Zhaoke Ophthalmology signed strategic partnership agreements with three of China's leading pharmaceutical supply chain service companies, Sinopharm Group Distribution Co., Ltd, Shanghai Pharmaceuticals Co., Ltd., and China Resources Pharmaceutical Commercial Group Limited to collaborate in areas including procurement models, logistics management, market developments, joint projects and information communication.

Turning to financial performance, Zhaoke Ophthalmology recorded a total loss of approximately RMB161.0 million for the six months ended 30 June 2022, compared to an approximately RMB1,987.7 million for the same period in 2021. During the period, the Company's R&D expenses reached approximately RMB100.9 million, compared to approximately RMB123.4 million for the six months ended 30 June 2021. Whilst the decrease in R&D expenses is mostly a result of the timing of various clinical programs, the Company is strictly focused on exercising discipline towards capital expenditure in light of overall financial market conditions.

As at the end of the Reporting Period, Zhaoke Ophthalmology recorded cash, cash equivalents and time deposits of approximately RMB1,860.3 million.

Dr. Li continued, "Looking forward, we anticipate the second half of 2022 will be an exciting period for Zhaoke Ophthalmology. Several milestones are expected to be completed in the coming months, including our partner Vyluma Inc. announcing the clinical results of their global three-year Phase III trial for NVK002. This will be an important step towards making this drug potentially the first US FDA-approved low-dose atropine for the treatment of myopia progression in children and adolescents."

He added, "Meanwhile, we will continue to adhere to our strategy ando combine our strong R&D capabilities, comprehensive asset portfolio and innovative commercialization approach to capture the huge unmet medical need not only in China, but also globally. With the dedication and unwavering passion of our employees, we are well positioned to capture the tremendous market opportunity."

Zhaoke Ophthalmology highlighted several pipeline updates as a part of the results announcement:

CsA Ophthalmic Gel for DED (self-developed)
Overview
CsA Ophthalmic Gel is an innovative drug being developed by us for the treatment of moderate to severe DED. It is a single, daily dose hydrogel which eliminates daytime administration and the associated discomfort and inconvenience and aims to dramatically improve patients' treatment compliance and quality of life. It is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing efficacy similar to that of Cyclosporine A products currently available for DED. However, unlike the current treatment, CsA Ophthalmic Gel's unique formulation stays on the eye for longer, requiring only once-a-day dosing (compared with traditional twice-a-day dosing). In the Phase III clinical trial for CsA Ophthalmic Gel, the treatment also showed a faster onset of action by demonstrating efficacy at around a two-week period, while other CsA drugs normally take around seven to eight weeks.

Updates during the Reporting Period
On June 8, 2022, the NDA for CsA Ophthalmic Gel was accepted for review by the CDE.

Our Company continues to target the commercialization of CsA Ophthalmic Gel in China as early as 2023. Due to the treatment's potential to benefit millions of people globally, we are also exploring opportunities outside of China.

NVK002 (Atropine) for Myopia (partnered with Vyluma)
Overview
To date, low concentration atropine is the only medication that is consistently effective in myopia progression control among children and adolescents. Our innovative treatment, NVK002, is currently positioned as the first clinically-proven pharmaceutical product approved for treating the progression of myopia globally. This treatment has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of more than 24 months. The clinical development of NVK002 involves two different concentrations of preservative-free atropine (0.01% and 0.02%) to determine the efficacy, safety and tolerability in children and adolescents with myopia, offering a distinct choice for doctors and patients.

Our Company's licensing partner for NVK002 is Vyluma, a wholly owned subsidiary of US-based Nevakar. Vyluma is currently conducting the Phase III clinical trial for NVK002 in the US and Europe. The results of the three-year trial are expected to be available by the end of 2022 and will be followed by an NDA submission to the FDA in 2023.

In September 2021, we received approval from the CDE to initiate two concurrent Phase III clinical trials, including China CHAMP and Mini-CHAMP. Combined with global data from Vyluma's Phase III clinical trial in the US and Europe, the overall trial for NVK002 will be one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world.

Updates during the Reporting Period
The main objective of China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in the treatment of myopia progression in children and adolescents from 3 to 17 years old.

Led by Professor Wang Ningli from Beijing Tongren Hospital as the principal investigator, the China CHAMP trial involves 19 centers and has completed the enrollment of 777 patients. Co-led by Professor Qu Xiaomei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from the Zhongshan Ophthalmic Center of Sun Yat-Sen University as the principal investigators, the Mini-CHAMP trial involves 18 centers and has completed the enrollment of 526 patients.

Both the China CHAMP and Mini-CHAMP have completed patient recruitment in July 2022, representing two and three months significantly ahead of schedule respectively. The early completion of patient recruitment across both trials gives our Company a strong head start in moving towards the goal of leading the market in launching a myopia progression treatment.

The drug could be available in the PRC market as early as 2024, potentially making Zhaoke Ophthalmology one of the first companies to commercialize a myopia drug in the PRC market.

BRIMOCHOL(TM) PF and Carbachol PF (partnered with Visus)
Overview
BRIMOCHOL(TM) PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct the loss of near vision associated with presbyopia. BRIMOCHOL(TM) PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a "pinhole effect" so that only centrally focused light rays are able to enter the eye, thereby sharpening both near and intermediate images.

In the VIVID Phase II study conducted by Visus in the US, both formulations met primary and secondary endpoints, demonstrating a three-line improvement in near visual acuity with no loss of distance vision out to nine hours. Both BRIMOCHOL(TM) PF and Carbachol PF were well tolerated with no serious adverse events. Phase III pivotal trials commenced in March 2022, with interim topline data expected in the fourth quarter of 2022.

Corresponding to the ongoing Phase III clinical study of BRIMOCHOL(TM)PF and Carbachol PF in the US, we plan to launch a clinical study in China for presbyopia in the near future.

TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM)
Overview
TAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing off label use of bevacizumab via intravitreal
injection for the treatment of wAMD.

Updates during the Reporting Period
In March 2022, Zhaoke Guangzhou, a wholly-owned subsidiary of our Company, and TOT BIOPHARM Co., Ltd. Suzhou, a wholly owned subsidiary of TOT BIOPHARM, entered into a supplemental agreement – pursuant to which Zhaoke Guangzhou will have full control in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou has also been given the right to develop TAB014 for other ophthalmic indications besides wAMD or novel formulations for ophthalmic indications.

On June 28, 2022, we completed the recruitment of the first patient for the Phase III clinical trial of TAB014.

The Phase III clinical trial of TAB014 is a randomized, double-blind and noninferiority study. The main objective of the study is to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in TAB014-treated subjects group compared with Lucentis(R)-treated subjects group. The study will involve up to approximately 60 centers and enroll a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the principal investigator.

ZKY001 (self-developed)
Overview
ZKY001 is a seven-amino acid peptide derived from the functional fragment of Thymosin beta4 that binds actin, a type of protein that plays a central role in cell structure and movement. We are exploring multiple indications as we believe this asset can potentially be applied to multiple disease indications.

ZKY001 has broad applications in the healing of corneal wounds and can potentially be used in multiple indications. We are currently exploring four indications for ZKY001, including CED, corneal epithelial defect, TPRK, a surgical treatment for myopia, pterygium, a growth in the cornea or the conjunctiva, and NK, a rare degenerative corneal disease.

Updates during the Reporting Period
We completed treatment for the last patient in the Phase II clinical trial of ZKY001 for CED in February 2022. On March 16, 2022, the first patient was enrolled for Phase II clinical trial for pterygium disease. On August 5, 2022, the first patient was enrolled for the Phase II clinical trial for TPRK. We will refine our clinical development strategy for this asset once we have the trial results across multiple indications.

NTC010
Overview
NTC010 is a fixed dose combination of antibiotics and steroids to prevent infection and inflammation for patients undergoing cataract surgery. The drug belongs to a new generation of antibiotics, which increase efficiency and cover a wider range of bacteria. The drug also shortens the duration of the treatment by half – from 14 to seven days – making it beneficial to patients' overall health and helping to prevent antibiotic overuse. The drug has already been approved in seven European countries. We plan to submit an NDA to the NMPA in the near future.

PAN-90806 (VEGFR2 inhibitor) for wAMD and DME (partnered with PanOptica)
Overview
PAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide.

PAN-90806 is a novel eye drop formulation, which decreases the number of injections required. If approved as a maintenance therapy, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients. This will reduce the frequency of intravitreal injections and other treatment issues associated with mainstream anti-VEGF therapies while at the same time maintaining visual stability. PAN-90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.

We are currently focused on optimizing the formulation of PAN-90806. Subject to regulatory approvals, our Company plans to commence human trials after completion of requisite animal studies.

Generic Drugs
We follow a balanced approach in designing our drug pipeline. In addition to innovative drug candidates, our Company has several key generic drugs in the pipeline. Generic drugs address a substantial portion of ophthalmic medical needs in China. From a market demand perspective, our generic pipeline complements our innovative pipeline and better positions us to become an efficient one-stop comprehensive solution provider. From a supply perspective, our generic programs also offer several strategic benefits.

During the Reporting Period, we continue to focus on commercializing Bimatoprost Timolol, a generic drug for glaucoma, as our first commercialized drug asset. The launch of this treatment will position us in the under-served glaucoma market and prepare us for the future commercial launch of our innovative drugs.

About Zhaoke Ophthalmology
Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021.

Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.

Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieving the objective of improving visual health in China through scientific research as soon as possible.

Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in the world.

For more information, please visit: www.zkoph.com

Media Contact:
Artemis Associates
Diana Footitt, CEO
M: +852 9183 0667
E: diana.footitt@artemisassociates.com

Bowen Chui, Director
M: +852 9783 0643
E: bowen.chui@artemisassociates.com

Iris Pei, Director
M: +86 15000 465 016
E: iris.pei@artemisassociates.com


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Sinomab Announces IND Application of SN1011 for the Treatment of Neuromyelitis Optica Spectrum Disorder Approved by NMPA

HONG KONG, Aug 24, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.

SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous ("SLE"), pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder("NMOSD") and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile.

Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.

NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company's new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor towards multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of Company's main candidate products, covering indications in the field of autoimmune diseases, have entered clinical stage gradually. Among which, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates moving forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoting to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases.

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


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Avantor and Avantor Foundation Make a Difference by Providing Critical Health Services for Vulnerable Communities in Singapore

Singapore, Aug 24, 2022 – (ACN Newswire) – Avantor Foundation, Avantor's philanthropic arm, committed financial resources to healthcare charitable organizations, HealthServe and SATA CommHealth, as part of the Foundation's mission to provide healthcare to those in need.

The grants will offer much-needed support to communities who would otherwise be unable to receive quality medical care. By identifying community needs and addressing them through these grants, the Avantor Foundation is able to contribute to the advancement of healthcare in Singapore and the region.

"As we continue to create a better world, grants like this demonstrate our commitment to providing healthcare to those in need," said Christophe Couturier, Executive Vice President, AMEA, Avantor and Board Member of the Avantor Foundation. "By working with SATA CommHealth and HealthServe, we want to connect and help communities, which deserve crucial assistance but are sometimes overlooked. The aid we are providing will address the critical unmet needs in healthcare and enable Science for Goodness, and ultimately create a lasting impact in our communities."

SATA CommHealth, an organization which serves the community through the provision of subsidized care in their medical centers, will work with approximately 50 community and grassroots organizations to provide free health screenings for the elderly and less fortunate through regular check-ups and early medical intervention to prevent chronic or deadly diseases.

"We are truly grateful to receive this generous donation from the Avantor Foundation," said Boon Khiang Chia, Director & Head of Strategic Partnerships & Branding, SATA CommHealth. "We will be able to facilitate collaboration with our community leaders and constituency representatives to effectively serve the healthcare needs of our beneficiaries, especially the elderly who are most vulnerable to poor health."

The Avantor Foundation also has provided a grant to HealthServe, a medical NGO that advocates for the needs and wellbeing of vulnerable, low-wage migrant workers in Singapore. Their services include healthcare, counseling, casework, mental health support and social assistance for their beneficiaries. HealthServe will use this grant for a nurse-led chronic disease case management program that supports migrant workers in need of medical assistance.

Michael Cheah, Executive Director, HealthServe said, "Bringing healing and hope to migrant workers has always been a cause that is very close to our hearts. This contribution from the Avantor Foundation will allow us to offer customized care plans to these workers in need of medical assistance and deliver better care outcomes for them in the long term."

About Avantor

Avantor, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.

For more information, visit www.avantorsciences.com/site/ and find us on:
LinkedIn – https://www.linkedin.com/company/avantorinc/
Twitter – https://twitter.com/Avantor_News
Facebook – https://www.facebook.com/Avantorinc/

About Avantor Foundation

As the philanthropic arm of Avantor, the Avantor Foundation's mission is to create a better world by advancing science education and providing healthcare to those in need. Since 2009, the Avantor Foundation has been making a difference in the science community by supporting organizations aligned to its mission. Learn more at www.avantorsciences.com/pages/en/avantor-foundation.

Media Contact
Christina Koh
Director, Communications – AMEA
Avantor
M: +65 9720 0169
Christina.Koh@avantorsciences.com

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Oculis announces publication of Phase 2 data showing topical eye drops anti-TNFa agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease

LAUSANNE, Switzerland, Aug 23, 2022 – (ACN Newswire) – Oculis S.A., ('Oculis') a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the results of the double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the effect of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe dry eye disease (DED) (NCT02365519) has been published by the Clinical Ophthalmology journal. The publication is accessible on the National Institutes of Health (NIH) website here. ( https://pubmed.ncbi.nlm.nih.gov/35821785/ )

The results from the study show that the change from baseline to Day 29 in the global ocular discomfort score, the primary efficacy endpoint, was statistically significantly greater for topical ocular licaminlimab (OCS-02) (-7.9) than for vehicle (-3.6) (90% CI -7.7, -0.8; p = 0.041). The percentage of patients with an improvement in global ocular discomfort score >20 from baseline to treatment day 29, one of the main secondary efficacy endpoints, was statistically greater for licaminlimab (17.9%) compared to vehicle (4.7%) (p=0.018).

Licaminlimab (OCS-02) was well tolerated in this study, with no major safety differences between licaminlimab (OCS-02) and vehicle treatment groups, and no increase in intra-ocular pressure was observed.

Licaminlimab (OCS-02) is a single-chain antibody fragment (scFv) that binds to and neutralizes the activity of human TNFa, with dual mechanism of action (MoA), anti-inflammation and anti-necrosis. Unlike full-length monoclonal antibodies, scFv fragments can penetrate ocular surface tissues when used as eye drops, due to the smaller size of the molecule giving it the potential to become the first approved topical biologic for DED.

Dry Eye is a multifactorial disease in which inflammation rapidly takes on a central role in sustaining the pathological state(1). The global prevalence of DED has been reported at 11.59%(2) , representing approximately 900 million people worldwide. In the US alone, there is currently between 16 million and 49 million people who have dry eye disease(3) . Significant unmet medical needs remain for this large and growing patient population with only 9% of diagnosed patients in the US receiving treatment(4) and despite current options, only 13% of patients are achieving lasting relief(5) .

Licaminlimab (OCS-02) is currently being investigated by Oculis in Phase 2 clinical trials for the treatment of dry eye disease and uveitis.

Pr Christophe Baudouin, M.D., Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris, commented: "There is a true unmet medical need for the development of drugs with new MOA to treat the inflammation involved in the pathogenesis of DED. OCS-02 is certainly one that could fill that gap. As compared to currently available treatment options and other product candidates in the DED pipeline, OCS-02 could play a role in the treatment of the underlying causes of the disease given its anti-inflammatory and anti-necrosis benefits. I certainly look forward to the continued development and approval of OCS-02 in severe dry eye disease as these patients currently have limited treatment options."

Riad Sherif, M.D., CEO of Oculis, said: "The Phase 2 data further reinforce our confidence in the potential of OCS-02 as a novel anti-inflammatory treatment for the effective management of Dry Eye Disease, but also for other inflammatory eye diseases. With Phase 2b clinical trials of OCS-02 for the treatment of dry eye disease and uveitis which are planned to start in the coming months, along with on-going Phase 3 clinical trials of OCS-01 in diabetic macular edema and inflammation and pain following ocular surgery and a proof-of-concept (POC) trial of OCS-05 in acute optic neuritis, we look forward with confidence to the further development of the Oculis Ophthalmology Franchise to address significant unmet medical needs in key areas of ophthalmology."

About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includescandidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Notes:
(1) Baudoin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDESEuropean Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles
(2) Eric B Papas "The global prevalence of dry eye disease: A Bayesian view" 2021
(3) https://dryeyedirectory.com/dry-eye-statistics/
(4) DRG Dry Eye Disease Landscape and Forecast 2020
(5) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Sino Biopharmaceutical (1177.HK) Announces 2022 lnterim Results, Revenue up by 5.9% to RMB15.19 billion

HONG KONG, Aug 23, 2022 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited Interim results for the six months ended 30 June 2022 (the "Period").

Development Highlights
— The Group achieved considerable sales growth from a number of new products and oncology products, with sales of new products launched within five years accounted for approximately 43.5% of the Group's total revenue in the first half of 2022, up from approximately 36.9% for the same period last year.

— As of 30 June 2022, the Group had a total of 40 innovative drug candidates in the oncology field, 8 innovative drug candidates in the field of liver disease, 9 innovative drug candidates in the respiratory system field in development process for clinical application, and 1 innovative drug candidate in the field of surgery/analgesia in phase III clinical trial. Furthermore, the Group had a total of 23 biosimilar or generic drug candidates in the oncology field, 9 other biosimilar or generic drug candidates in the surgical/analgesic field, 5 biosimilar or generic drug candidates in the field of liver disease and 20 biosimilar or generic drug candidates in the respiratory system field in development process for clinical application.

— Focus V (Anlotinib Hydrochloride Capsules) was approved for the fifth indication-differentiated thyroid cancer in the first half of 2022. To date, Anlotinib has been approved for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer and differentiated thyroid cancer.

— TDI01 is a highly selective inhibitor of ROCK2 and is currently in development process of phase I clinical trial for the target indications of pneumoconiosis, pulmonary fibrosis and graft versus host disease. There is no approved drug for pneumoconiosis worldwide, TDI01 is expected to fill this gap and be a boon to pneumoconiosis patients.

— SFT-1001 and SFT-1003 are two soft mist inhalation products that are currently in late clinical stage. As of 2021, there are only five soft mist inhalation products available worldwide, with a global market size of over US$3 billion and a compound growth rate of over 35% in the past five years, and the global soft mist market is expected to each US$7 billion by 2030.

During the Period, the Group recorded revenue of approximately RMB15.19 billion, an increase of approximately 5.9% against last year. Profit attributable to the owners of the parent company was approximately RMB1.92 billion. Earnings per share attributable to the owners of the parent company were approximately RMB10.30 cents. Excluding the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), certain non-cash items and one-off adjustments, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.66 billion, an increase of approximately 4.5% over that in the same period last year. Sales of new products accounted for approximately 43.5% of the Group's total revenue for the period, while it was approximately 36.9% for the same period last year. The Group's liquidity remains strong, with cash and bank balances classified under current assets of approximately RMB7.77 billion, bank deposits classified under non-current assets of approximately RMB6.84 billion, and wealth management products of approximately RMB7.64 billion in aggregate, the Group's total fund reserve was approximately RMB22.25 billion at the period end.

The Board of Directors has declared the payment of an interim dividend of HK6 cents per share. (2021: HK4 cents).

Sales: Harvested years of R&D results, sales of new products as a percentage to revenue climbed
The Group has obtained significant benefits from years of high research and development, and continues to focus on development of related products in the areas of specialist therapeutic. During the period, the sales revenue of new products launched within five years was approximately RMB6.61 billion, accounting for approximately 43.5% of the total revenue of the Group from approximately 36.9% last year.

During the Period, the Group's oncology, liver disease and cardio-cerebral vascular medicines continued to lead in sales contribution. Sales of oncology medicines increased by 16.7% year-on-year to approximately 4.96 billion, accounting for approximately 32.6% of the Group's revenue. Sales of liver disease (hepatitis) medicines and cardio-cerebral vascular medicines increased by approximately 11.1% and 13.8% year-on-year to approximately 2.01 billion and 1.55 billion, respectively, accounting for approximately 13.2% and 10.2% of the Group's revenue. In addition, the sales contributions of products in various areas such as surgery/analgesia, respiratory system and others went up hand-in-hand. Sales of surgery/analgesia and respiratory system medicines accounted for approximately 16.6% and 10.0% of the Group's revenue, respectively.

In the area of oncology, since its launch in 2018, the revenue from sales of Anrotinib has continued to grow rapidly and is expected to grow at a compound rate of 46% in the period between 2018 and 2022. During the Period, sales of Annike (Penpulimab monoclonal antibody injection) increased significantly against the same period last year. F-627 (Efbemalenograstim alpha, long-acting granulocyte colony-stimulating factor) is currently under marketing application stage. It provides a safety advantage over mainstream second generation products currently on the market, is expected to be approved in China in the first half of 2023.

In the area of surgery/analgesia, the Group focused on hospital access and high-potential area development, specifically on developing and increasing coverage of secondary hospitals and community healthcare facilities, driving the rapid growth of Debaian (Flurbiprofen) Cataplasms in the first half of the year.

In the area of liver disease, the Group made efforts to strengthen academic promotion so as to expand doctor coverage and enhance expert recognition, as well as actively identified new patients and new market to develop, driving the rapid growth of sales revenue of Tianqing Ganmei Injection during the Period.

R&D: Continued to focus on new products in specialist therapeutic areas
The Group has continued to focus R&D efforts on new oncology, surgery/analgesia, hepatitis, respiratory system and cardio-cerebral vascular medicines. As of 30 June 2022, a total of 418 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Of them, 29 were for under hepatitis, 230 for oncology, 31 for respiratory system medicines, 9 for endocrine, 16 for cardio-cerebral medicines, 3 for surgery, 4 for analgesia and 96 for other medicines.

Prospects: Two-pronged approach of independent research and development, focusing more on products with high innovation and market potential
In the future, the Group will build a healthier, more diversified and sustainable revenue structure by continuing to build on traditional public hospital sales, invest more resources in new marketing channels and new marketing tools, and gradually expanding their share of revenue. In view of the potential impact of the national volume-based procurement policy on generic drugs, the Group has re-evaluated and optimised its product lines under development from the perspective of innovation and market value, focusing more on products highly innovative and with market potential.

The Group will continue to invest more resources in innovative R&D facilities, personnel and projects. Innovation has become a key driver of growth for the Group, with the share of revenue from innovative medicines expected to reach 24% by 2022. Looking ahead, the Group plans to attain revenue exceeding the RMB10 billion mark from innovative medicines by 2023, further increasing the share of revenue from them in the Group's total. The Group aims to become a world-class innovative pharmaceutical group by 2030, with a revenue target of HK$100 billion, of which over 60% is expected to be contributed by innovative drugs.

Looking ahead, the Group is focusing on four therapeutic areas, namely oncology, surgery/analgesia, liver disease and respiratory system, and will strive to achieve its 2030 target by adopting a two-pronged approach – pursuing independent research and development and innovation-driven business development.

About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D-driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group's products have gained a competitive foothold in various therapeutic categories with promising potential, comprising a variety of biopharmaceutical and chemical medicines for oncology, surgery/analgesia, hepatitis, and respiratory system.

Sino Biopharmaceutical is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng China Enterprises Index, Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng SCHK Mainland China Healthcare Index, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index, etc.. Sino Biopharm was ranked as one of "Asia's Fab 50 Companies" by Forbes Asia for three consecutive years in 2016, 2017 and 2018.



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