Bio Farma secures multi-year Purchase Contract from UNICEF for its novel Oral Polio Vaccine type 2 (nOPV2)

BANDUNG, INDONESIA, Oct 2, 2022 – (ACN Newswire) – PT Bio Farma (Persero), the holding company for pharmaceutical state-owned enterprises (SOEs), will export its novel Oral Polio Vaccine type 2 (nOPV2) having secured a purchase contract with the United Nations Children's Fund (UNICEF) for 2022 & 23. Under the contract, Bio Farma will export its oral polio vaccines based on purchase requests from UNICEF via multilateral contract agreement for the years 2022 & 23.




Indonesian State-Owned Enterprises (SOEs) Minister Erick Thohir has said, "In line with the theme of the Indonesian G20 Presidency, "Recover Together, Recover Stronger", it is important for Indonesia's state-owned enterprises to lead with concrete actions realized through strategic initiatives and large-scale transformations to create global impacts."

Honesti Basyir, President Director of Bio Farma, said, "UNICEF procures nOPV2 under a multilateral supply agreement as part of a global effort to prevent spread of the polio disease. Bio Farma will provide its annual production to the global nOPV2 stockpile, which is a contribution to the global health industry, as we are able to manufacture stockpiles that fulfill world needs. In turn, we will fulfill individual deliveries to target countries or regions following UNICEF request."

The nOPV2 vaccine received an Emergency Use of Listing (EUL) from the World Health Organization (WHO) in November 2020, the first ever vaccine certified for emergency use, adding to Bio Farma's portfolio of products that were already available globally. It was initially used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs) in a number of African and East Mediterranean countries.

Bio Farma's nOPV2 vaccine is now distributed internationally, ex-Indonesia, as Indonesia has been polio-free since 2014. Target countries in Africa for the vaccine have included Algeria, Cameroon, Kongo, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, it is administered in Israel and Ukraine, and in the Middle East, in Egypt, Iran, Somalia and Yemen.

According to Honesti, nOpV2 vaccine is a result of collaboration between Bio Farma and several international research institutes, including Bill and Melinda Gates Foundation (BMGF), PATH, and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67% of the global stockpile, while Bio Farma's laboratories have become the reference for sampling polio vaccines in the world.

In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like the Bill and Melinda Gates Foundation (BMGF), the PATH, and the WHO. Bio Farma has since become the main supplier of polio OPV vaccines in the world, and currently contributes 67% of the global OPV stockpile.

Bio Farma's Laboratories have also been widely acknowledged as reference labs for poliovirus testing, while Bio Farma's success in producing and exporting the nOPV2 vaccines shows the Indonesian company fully contributing to the world health sector, apart from providing the necessary vaccines at home in Indonesia.

In Line with G20

Honesti said Bio Farma's provision of vaccines is in line with a main pillar of the Indonesian G20 Presidency (2021-22), Global Health Architecture. Through its G20 Presidency, Indonesia has showcased its success in controlling the Covid-19 pandemic and maintaining public health and steady economic growth through vaccination. Bio Farma has been a front liner in the government-initiated vaccination program.

Bio Farma has been ready to mass-produce its IndoVac brand Covid-19 vaccine.* On September 24, an Emergency Use of Authorization (EUA) was granted by the Indonesian Food and Drug Authority (BPOM), following the halal certification from the Indonesian Ulema Council (LPPOM MUI), and the Halal Certification Agency (BPJPH).

With this EUA and certification, mass production of IndoVac is beginning immediately, as preparation work for the first batch was already in place at the company's facility in Bandung. Bio Farma plans to increase its production capacity to 40 million doses next year, and to 100 million doses by 2024, given demand in the global markets.

Bio Farma hopes that its IndoVac vacciness can contribute to reducing the spread of Covid-19 in the world, much as its nOPV2 vaccine has contributed to reducing the polio spread.

About Bio Farma

PT Bio Farma (Persero), the holding company for pharmaceutical state-owned enterprises (SOEs), offers end-to-end services across the healthcare spectrum – from pharmaceutical research and development, manufacturing and distribution to the operation of retail pharmacies, health clinics and clinical laboratories. Bio Farma's head office and production facilities are in Bandung, West Jawa, with a representative office in Jakarta, Indonesia's capital city.

Bio Farma is a leading human vaccine producer with production capacity of 3.2 billion doses per year, and has exported its vaccines to more than 150 countries. Bio Farma recently became the parent through merger of listed state-owned pharmaceutical companies PT Kimia Farma Tbk (IDX: KAEF), PT Indofarma Tbk (IDX: INAF) and PT Phapros Tbk (IDX: PEHA). For further information, please visit www.biofarma.co.id

Media contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

* 9/11/22: "Bio Farma ready to mass produce IndoVac brand Covid-19 vaccine"
https://www.acnnewswire.com/press-release/english/77878/indonesia's-bio-farma-ready-to-produce

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

Corinium presents: CISO Healthcare APAC Online

Singapore, Sep 19, 2022 – (ACN Newswire) – Exclusively designed for today's healthcare InfoSec leaders to compare their strategies and to learn, network with forward-thinking peers, to discuss how the healthcare industry can use information security to reform and revolutionise the patient experience.



Taking place across two days, this online event delivers the content you cannot find anywhere else. Are you ready to accelerate your data and analytics journey?

The conference will cover a range of cutting-edge case studies and issues tackled will include data governance, data privacy and consent!

CISO Healthcare Online APAC provides the unique opportunity to connect, learn, and do more business, effectively, safely and with confidence.

Join us, 22-23 November, for over two action-packed days and the event will bring together infosec leaders from key healthcare providers across the region!

2022 Key Themes:

– Threats to Healthcare Information Exploring the vulnerabilities of information system in healthcare through case studies and what was done in the past to mitigate risks
– Digitalisation of Healthcare Exploring the risks and benefits of digitalisation and virtual care services, and how to deploy them securely
– Cybersecurity as a Shared Responsibility Supporting and educating healthcare workers on ways to keep information safe and steps to respond to an attack
– Building a Resilience Healthcare Information System Preparing your security plan, process, and governance by taking into account new risks and threats and implementing different strategies to safeguard vulnerabilities

Claim your FREE place today!

We cannot wait to host you online during the event for two days of learning, sharing, and networking!

For Further details regarding this event, visit our website
https://cisohealthcare.coriniumintelligence.com/

You can contact us at:
info@coriniumintel.com

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

Indonesia’s Bio Farma ready to produce ‘IndoVac’ Covid-19 vaccines

BANDUNG, INDONESIA, Sep 12, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in manufacturing IndoVac, its Covid-19 vaccines brand, including primary series vaccines, booster vaccines and vaccines for children, in development since November 2021.


IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)


Honesti Baasyir, President Director of Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

According to Honesti, "IndoVac uses vaccine technology platforms which are compatible with our equipment and facilities. The technology platforms for protein recombinant vaccines also offer other benefits; they can be adapted to new strains of Covid-19.

"Results from primary series Phase 1 and Phase 2 clinical trials show that IndoVac vaccines offer quality safety and efficacy, no less competitive than other Covid-19 vaccines. Now we are completing documentation to wrap up Phase 3."

Honesti said Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July to provide necessary Phase 3 primary series data, so the BPOM can release an Emergency Use Authorization (EUA) permit for the vaccine. The EUA is the permit for medical supplies, including vaccines and medications, used during a public health emergency.

In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country. BPOM's head Penny K. Lukito, during a hearing at the Indonesian House of Representatives, said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September.

Shariah Compliance

Bio Farma has also processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccine. The vaccine has passed an audit by The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product. The certificate from the Halal Certification Agency (BPJPH) of the Religious Affairs Ministry is expected to be released soon after the BPOM EUA for IndoVac.

After securing all the necessary permits, Bio Farma will be ready to move on to the next stage, mass production of the vaccine. Bio Farma plans to produce an initial 20 million doses of primary series vaccine this year, which will be further increased to 40 million doses in 2023, as the company expands its production facilities. In 2024, production may further increase to 100 million doses per year, depending on demand and the market.

Booster Vaccine and Vaccine for Children

Bio Farma also started clinical trials for its booster vaccine on September 1. Bio Farma conducted the trials for its booster vaccine at Hasan Sadikin General Hospital in Bandung (Faculty of Medicine, Padjajaran University) and Dr I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Dept, Udayana University). Trials involved 900 subjects aged 8 and above to test the booster vaccines. Next, the company plans to conduct clinical trials for children, following registration with the BPOM.

All Covid-19 vaccines made by Bio Farma, including the primary series vaccines, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.

President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said.

Made-in-Indonesia Vaccines

Honesti said IndoVac is special, as one of the few made-in-Indonesia vaccine products, developed and manufactured for the nation's children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the IndoVac vaccines, according to Bio Farma, will be around 80%.

"This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines," Honesti said.

Bio Farma hopes to capture the export market with its IndoVac vaccines. "We will not only produce them to meet domestic needs, but for the supply of global markets," said Honesti. "We registered for EUL with the World Health Organization (WHO), so the vaccine can be used in other countries through Covax Facility multilateral procurement. (The EUL assesses and lists vaccines during emergencies in non-vaccine-producing countries.)

"With our Covid-19 vaccines, we hope to contribute to the health industry, not just in Indonesia, but in the world," said Honesti.

For Bio Farma, it is not the first experience with clinical trials, having conducted more than 30 clinical trials (including Covid-19) in Indonesia. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).

Bio Farma's Success in Polio Vaccine

Honesti said apart from the Covid-19 primary series vaccines, Bio Farma previously secured EUA from BPOM and EUL from WHO for its novel Oral Polio Vaccine type 2 (nOPV2). As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. However, the Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.

Among the countries in Africa that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.

In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).

Bio Farma's Laboratories have been internationally acknowledged as reference labs to check samples of polio viruses, while Bio Farma's success in producing and exporting nOPV2 vaccines shows the Indonesian state-owned company contributing to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

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

Indonesian pharmaceutical Bio Farma ready to produce IndoVac Covid-19 vaccines

Bandung, W Java, Indonesia, Sep 9, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.


IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)


Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

PT Bio Farma has completed Phase 1 and Phase 2 clinical trials and is currently in the Phase 3 stage to produce the primary series vaccines or two vaccine doses for everyone aged 18 years and older.

"IndoVac uses vaccine technology platforms which are compatible with the equipment and facilities within our factories. The technology platforms for protein recombinant vaccines also offer other benefits: they can be adapted to the new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials showed that IndoVac offers quality safety and efficacy, not less competitive than other Covid-19 vaccines. Now we are completing a report to wrap up Phase 3."

Honesti said, Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July 2022 to provide the necessary data, so that BPOM can release the Emergency Use Authorization (EUA) permit for IndoVac's primary series vaccines in the near term.

The EUA, released by a country's regulatory agency, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country.

BPOM's head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September 2022.

Shariah Compliance

Bio Farma also has processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccines to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product.

The certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry is expected to be released in the near term after BPOM release the EUA for IndoVac.

After securing all the necessary permits, Bio Farma is ready to move on to the next stage, which is producing IndoVac's primary series vaccines massively. At the first stage, Bio Farma plans to produce a maximum of 20 million doses of primary series vaccines, before this can be further increased to 40 million doses in 2023, as the company expands its production facilities.

In 2024, the company may further increase the volume to 100 million doses per year, depending on the demands and needs in the markets. Honesti said after the company has secured all the necessary permits, then IndoVac's primary series vaccines "can be massively used by people aged 18 and above."

Booster Vaccine and Vaccine for Children

At the same time, Bio Farma also started clinical trials for its booster vaccine on September 1, 2022. "We have secured approval for a clinical trial (PPUK) from BPOM for IndoVac booster vaccine," Honesti said. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM.

Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine of Padjajaran University, Bandung) and Dr. I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Department, Udayana University). Trials involved 900 subjects aged 8 and above to test IndoVac's booster vaccines.

BPOM requires vaccine manufacturers to conduct clinical trials to decide if a vaccine is safe and can boost immunity against Covid-19, and to determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.

All Covid-19 vaccines made by Bio Farma, including the primary series, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.

President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said.

For Bio Farma, it is not the first time embarking on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes the Phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).

Made-in-Indonesia Vaccines

Honesti Basyir said IndoVac is special as one of the few made-in-Indonesia vaccine products. The vaccines (which include the primary series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for nation's children. Bio Farma handles the manufacturing process from upstream to downstream.

The local contents of IndoVac's primary series vaccines, according to Bio Farma, will be around 80%. "This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines. This will also impact foreign exchange reserves," Honesti said.

In the long term, Bio Farma hopes to capture the export market with IndoVac vaccines. "We will not only produce them (the three types of vaccines) to meet domestic needs but also target the supply of global markets," he said.

"We registered for Emergency Use Listing (EUL) with the World Health Organization (for primary series), so this vaccine can be used in other countries through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not just in Indonesia, but also to the world."

Bio Farma's Success in Polio Vaccine

Honesti said apart from manufacturing Covid-19 primary series vaccines, which is currently waiting for the results of Phase 3 clinical trials and the EUA, Bio Farma has previously proven that it can secure the EUA from BPOM and the EUL from the WHO for its novel Oral Polio Vaccine type 2 (nOPV2).

The EUL, which is released by the WHO, is a procedure for assessing and listing vaccines during public health emergencies by non-vaccine-producing countries. As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.

Among the countries that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.

In the manufacturing of nOPV2 vaccine, Bio Farma collaborated with world-class research institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier for the polio vaccine in the world. The company currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).

Apart from producing polio vaccines, Bio Farma's Laboratories have secured international acknowledgement as the reference labs to check samples of polioviruses. The world was previously waiting for two countries, Afghanistan and Pakistan, to combat polio diseases, before a 'world-free polio' can be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East.

The nOPV2 vaccine became an important product to prevent further spread of the polio disease. Bio Farma's success in producing and exporting nOPV2 vaccine means that the Indonesian state-owned company has contributed to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

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

CT Event Asia to host ASEAN Healthcare Transformation Summit 2022

KUALA LUMPUR, Sep 1, 2022 – (ACN Newswire) – This year, CT Event Asia is all set to bring you the Asean Healthcare Transformation Summit 2022, themed "Leveraging Human Touch and Technology in the Era of Connected Health". Happening at the JW Marriot Hotel on 6th-7th September 2022, this conference is the most interactive healthcare summit in Southeast Asia, aims to address the most pressing issues in the healthcare sector. The summit promises to be even larger and will feature keynotes sessions emphasizing on the digital health ecosystem, public health systems transformation, universal health coverage, robots in healthcare, integrated hospitals and burnout in HCW.



This summit will be supported by 4 focused streams on 'healthcare digitalisation & innovation', 'value based & patient centered care', 'patient safety & quality' as well as 'lean management & operations excellence'.

We are anticipating over 500+ participants from utility leaders, Hospitals, Government agencies, Pharmaceutical, Solution providers, IT and Investors to discover the healthcare landscape, transformation solutions in healthcare, emerging trends in the industry and new health-tech to stay relevant in your profession in a challenging and complex operating environment. Here is our speaker list!

Join us now to get more insights from the healthcare industry leaders and meet our Sponsors and Partners as well with all of this to explore, our Asean Healthcare Transformation Summit 2022 is set out to be bigger than ever! Here's our list of Sponsors and Partners.

The Asean Healthcare Transformation Summit 2022 website has full details about the program. Interested parties can visit the website here or request for the event brochure here.

To get in touch with our team for enquires relating to this event, feel free to reach out to:
Camara
Partnership Director
CT Event Asia
+60 16 283 2660 | +03 2710 7756
camara@cteventasia.com

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

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

Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years

Cambridge, MA, Jul 19, 2022 – (ACN Newswire) – Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia.

"We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA," said Michael Azrak, General Manager of Moderna for Australia and New Zealand. "The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2."

Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.

The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.

Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).

The TGA previously approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.

Authorized Use

Therapeutic Goods Administration has provisionally approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company's COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Moderna Contacts

Media:
Luke Mircea-Willats
Director, Media Relations & Communications
Luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

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

Avantor Named Best Company for Upstream Processing and Single-Use Solutions at BMK 2022

Awards recognize Avantor innovations that allow the biopharmaceutical industry to bring therapies to market more efficiently

Incheon, Korea, June 30, 2022 – (ACN Newswire) – Avantor, Inc., a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, acquired awards for the best company in upstream processing and single-use solutions at the Biologics Manufacturing Korea (BMK) 2022 conference.

Sang Kyu Lee, Representative Director – Avantor Korea/Japan (Left), James Hwang, Head of Application, Asia, Middle East & Africa – Biopharma after receiving the Awards for Best Company in Single-use Solutions and Upstream Processing at BMK 2022

This is the second consecutive year that Avantor has been recognized for its upstream processing capabilities, a testament to its ongoing investment and innovations including development of high-purity raw materials, reagents and differentiated cell culture processes. In single-use solutions, Avantor received the best company award for the third consecutive year. Avantor was recognized for strengthening production capabilities and establishing an optimized supply chain in collaboration with global partners to respond to the growing need of biopharmaceutical manufacturers for single-use solutions.

Narayana Rao Rapolu, Vice President, Biopharma Asia Middle East & Africa for Avantor said, “Avantor’s single-use solutions enable biomanufacturers to bring new therapies to market faster and improve global health. Our local teams have expertise and experience across multiple processes that drive therapies forward from prototype development to system design, production and delivery. We offer the choice, agility and speed needed to support the evolving life-sciences market in Korea and across the region.”

Sang Kyu Lee, Representative Director for Avantor Korea & Japan said, “We are proud to be recognized for Avantor’s ability to support biopharmaceutical manufacturers through our comprehensive product portfolio and customer-driven production technologies. We continue to introduce innovations that allow life-changing therapies to reach the patients who need them.”

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 avantorsciences.com and find us on LinkedIn, Twitter and Facebook.

About The Korea Bioprocessing Excellence Awards

The Korea Bioprocessing Excellence Awards aims to recognize organizations within Korea that have engaged in substantial efforts to innovate, optimize processes and uphold a high level of efficacy, quality and safety in biological products manufacturing.

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

Global Media Contact:
Petro Kacur
Director, PR and External Communications
Avantor
M: 404-408-0663
Petro.Kacur@avantorsciences.com



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

SINGAPORE ANNUAL MEETING: DIA and CoRE Gathering Key Healthcare Experts in Neutral Forum to Discuss Regulatory News and Drug Development

Singapore, Jun 15, 2022 – (ACN Newswire) – The COVID-19 pandemic has ushered an increased speed of healthcare innovations with the hope of effectively managing this public health threat. This meeting offers a neutrally organized forum to discuss lessons learned and better prepare the healthcare system for the next challenges. From 12-13 July, representatives from Regulatory agencies, health authorities (Ali Al dalaan,[SFDA] Wen-Yi Hung[TFDA] Shin-ichi Okudaira [PMDA]) Jesusa Joyce N. CIRUNAY [Philippines FDA] and industry leaders (Serena Chan [Syneos Health], Daniela Caiazza [Novotech], Ralf Altenburger[Roche], Yu LIANG [MSD], and many more) meet in person for the first time in two years to foster positive changes in the healthcare environment in the Asia-Pacific. That includes emerging technologies, innovations in cancer care, digital health and improved patient access to novel therapies.



Sessions discussing Digital Health, Decentralized Clinical Trials, and access to Innovative Therapies

Connecting different perspectives and interests in a neutral forum allows an open dialogue and facilitates solutions and concrete action points for today's healthcare challenges, such as:

Fostering digital health adoption in the Asia-Pacific is highly dependent on regulatory frameworks. The session will discuss benefits of digital health, personalised care and what is necessary to improve application in the region.

The dynamics of decentralised clinical trials has the potential to improve patients' experience. Serena Chan (Syneos Health Singapore), Daniela Caiazza (Novotech), and Jerome Armellini (IQVIA Singapore) will discuss how decentralised trials can benefit patients, clinicians, trial sites and sponsors beyond the pandemic setting.

Novel approaches for managing cancer come from innovative cell and gene therapies. Challenges arise when it comes to country-specific regulations. Together with other specialists, Ralf Altenburger (Global Head Cell and Gene Therapy, F. Hoffmann La-Roche) will present where the field is going as an integral part of cancer care.

Building regulatory agility for improved patient access became more aware throughout the pandemic. Ali Al dalaan (SFDA) will present his view on regulatory convergence and discuss with industry leaders how to improve patient access through regulatory agility.

Empowering the ASEAN patients is subject of a townhall format, where all participants wrap up the conference and discuss the efficiency and sustainability of healthcare systems in ASEAN and identify next steps.

About DIA Singapore Annual Meeting
Date: 12-13 July 2022
Location: Grand Copthorne Waterfront Hotel, Singapore
Havelock Road
Singapore 169663
Singapore

Registration information:
Register before the 30th of June and get a 25% discount using the following code: SAM2022
– Register online here: https://bit.ly/3aPsB9o
– Register with one of our Team member: kanchan.patel@DIAglobal.org

About DIA

DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers, and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.
DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East, and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

Connect with DIA:
Twitter: https://twitter.com/DrugInfoAssn
LinkedIn: www.linkedin.com/company/dia
Facebook: www.facebook.com/DrugInformationAssociation/
Instagram: www.instagram.com/druginfoassn/

About Centre of Regulatory Excellence (CoRE):

Launched in 2014, CoRE at Duke-NUS Medical School, is the first dedicated Asian centre targeted at addressing the capacity development and policy innovation needs of national health regulators, the biomedical industry, and pharmaceutical and medical device companies. The Centre provides a neutral academic platform to establish regional platforms and networks to exchange knowledge, encourage innovation, promote thought leadership and collaboration in strengthening regulatory science and policy, and health systems frameworks, within and among national regulatory agencies, industry, health ministries and academia.

Contact:

CoRE
Sherna WADIA
Associate Director
Centre of Regulatory Excellence
Duke-NUS Medical School
Email: core@duke-nus.edu.sg

DIA
Kanchan PATEL,
DIA Associate Director, India-Singapore Operations
Email: kanchan.patel@DIAglobal.org

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