SHANGHAI, CHINA, Apr 23, 2021 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), today announced that the New Drug Application (NDA) for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA). Dorzagliatin is the first glucokinase activator (GKA) to submit a NDA for the treatment of diabetes, and has the potential to become the first first-in-class drug to be launched in China.

Relying on Hua Medicine's original scientific concept of "repair the sensor, restore homeostasis, and treat the underlying cause of diabetes," the Company has always focused on addressing unmet medical needs since its establishment. The Company is committed to developing breakthrough products with innovative concepts, and advancing and establishing clinical practice and treatment standards globally. Dorzagliatin is the world's first new GKA diabetes drug for which a NDA has been submitted, with a new mechanism of action, new targets, new structures, new formulations and new curative effects. Dorzagliatin is the world's first new oral treatment for diabetes launched by a Chinese biotechnology company. Its mechanism of action directly targets the underlying cause of T2D. By repairing the damaged glucokinase sensor function in diabetic patients, dorzagliatin can significantly improve the beta-cell function and reduce insulin resistance in patients with T2D, effectively control the progress of T2D, and has therapeutic prospects in patients with diabetic nephropathy.

Today, diabetes is a major public health problem. According to a survey published by the British Medical Journal (BMJ) in 2020, based on the diagnostic criteria of the American Diabetes Association (ADA), the total number of diabetic patients in China is approximately 130 million. Compared with the large number of patients, the diagnosis rate of T2D in China is only 43.3%, and the treatment rate is only 49.0%. In recent years, China has emphasized the importance of prevention and treatment of diabetes. The "Healthy China Action (2019-2030)" has clearly defined the goal. By 2030, the diagnosis rate of diabetes among citizens aged 18 and above will reach above 60%, and the standardized management rate will reach above 70%. The diabetes treatment rate, control rate and complication screening rate is expected to continue to increase.

In the past ten years, the global diabetes market has grown rapidly. In 2019, the global expenditures spent on diabetes was approximately 760 billion USD, and the spending in China alone is approximately 109 billion USD. The market potential is exceptionally large. With the successive launches of the China Type 2 Diabetes Prevention and Treatment Guide (2020 Edition) by the Chinese Diabetes Society and the ADA's Diabetes Diagnosis and Treatment Pathway (2021 Edition), the concept of "glucose homeostasis" has become the standard for treatment of diabetes. The development of glucokinase activator for "glucose homeostasis" as the core has also attracted attention.

In December 2020, Hua Medicine announced that it has successfully completed two Phase III registration trials of dorzagliatin, of which SEED (HMM0301) is a monotherapy trial in drug naive T2D patients, and DAWN (HMM0302) is a trial of dorzagliatin combined with metformin in T2D patients who are metformin-tolerant. The two trials demonstrated fast onset, potent, and sustained HbA1c reduction, and significantly reduced 2H-PPG. Dorzagliatin also demonstrated good safety and tolerability, improved beta-cell function and reduced insulin resistance. Two Phase I clinical studies conducted in the first half of 2020 showed that the combination of dorzagliatin with sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor) showed a significant synergistic effect in blood glucose control, indicating that dorzagliatin has broad application potential in T2D patients with different glucose control needs at different disease stages. Another Phase I study conducted in patients with end-stage renal impairment showed that dozagliflozin monotherapy can provide treatment opportunities for diabetic nephropathy (DKD), which accounts for about 20%-40% of the T2D population. It has potential to become a hypoglycemic agent for diabetic nephropathy without dosage adjustment.

In the process of preparing for the commercialization of dorzagliatin, in August 2020, Hua Medicine formed a strategic cooperation agreement in China with the global pharmaceutical giant and leader in Chinese diabetes treatment, Bayer. Hua Medicine's innovative capabilities and Bayer's leading advantage in the field of diabetes management in China will enable this world's first innovative drug to benefit Chinese diabetic patients as soon as possible. In September 2020, the Company received the "Drug Manufacturing Permit" for dorzagliatin from the Shanghai Drug Administration, completing the core work of preparation for commercial production.

Dr. Li Chen, founder and CEO of Hua Medicine, said: "We are very pleased that dorzagliatin's NDA application has been accepted by the NMPA. This is a major milestone for Hua Medicine. On the path to first-in-class, first-in-China, Hua Medicine has always strived to stand at the forefront of reform and pharmaceutical innovation, and contribute to the development of China's pharmaceutical industry and its people's health. Diabetes chronic disease management is a major work to protect national health, For the past 10 years Hua Medicine has committed to "China Leading Pharmaceutical Innovation", and actively explored the development and review and approval of China's first innovative drug with the Drug Evaluation Center, and achieved significant achievements in the field of innovative drug development with the spirit of "a sword in ten years." We have achieved breakthrough and developed this global innovative drug, allowing China to join the world in first-in-class drug development. We are very proud of this achievement and we look forward to working with our partners to jointly promote dorzagliatin in China."

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted the NDA for dorzagliatin to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

Forward-looking Statement
This article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.

For more information
Hua Medicine
Website: www.huamedicine.com
Investors
Email: ir@huamedicine.com
Media
Email: pr@huamedicine.com

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ADELAIDE, AU, Apr 22, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.

Title: Decentralized Trials – No Going Back
Link: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/
Time: 23 April, 2021 – 3.05 pm (Australia/Adelaide ACST).

Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent.

"DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen.

"The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk."

Yvonne Lungershausen said there are considerable benefits to DCT's including:

– Reduce the scheduling and travel burden on patients – providing care from the comfort of the patient's home.
– Connecting patients to trials on a global scale – patients that were otherwise inaccessible under more traditional trial protocols are now available.

And she said challenges include:

– Missed human-to-human contact and continuity of patient care
– Investigational product distribution to more remote destinations
– Oversight of compliance and study procedures in the patient's home

The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.

– Wearable devices are demonstrating enormous potential whether worn as a wrist strap or an adhesive patch on the body. AI-embedded capabilities allow these devices to measure a patient's heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data real-time.
– Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
– Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require the use of a lancet and finger prick whereas others do not, making clinical trials even more convenient.

Take the Quiz – Test your Knowledge about Australian Clinical Trials here:
https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Learn more at http://www.avancecro.com.

Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com

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Adelaide/Brisbane, Australia, Apr 7, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced the purchase of leading biolab TetraQ, based out of the University of Queensland.

Agilex Biolabs CEO Jason Valentine said the Board and senior management at Agilex Biolabs were extremely pleased with the purchase of such a high-calibre bioanalytics company.

"TetraQ complements the Agilex Biolabs work in Australia and APAC with its expert staff and years of experience in regulated bioanalytical services," he said.

"The TetraQ purchase is part of our regional expansion plans."

"Agilex Biolabs is already the largest and most technologically advanced biolabs in Australia, and the TetraQ addition to the business will further expand support for biotech clients running trials in Australia."

"We are also looking forward to introducing our clients to the well-established TetraQ toxicology capabilities for their discovery and pre-clinical work in Australia, which can also attract the 43.5% tax rebate."

"The clinical trials bioanalytics sector is one of the fastest-growing services globally with Australia and APAC a preferred location for conducting trials – especially since the COVID-19 pandemic."

TetraQ Director Dr Peter Tapley said he was very pleased that TetraQ was now an Agilex Biolabs company.

"They are the leader in the sector with 24 years of experience, and offer our clients a significantly expanded range of services and technologies," he said.

"Agilex Biolabs is known globally for its comprehensive services, specialist scientists, and the very latest technology. So this is the ideal next step for TetraQ and its staff and clients."

"I am pleased to be working alongside Agilex Biolabs' CEO Jason Valentine as we expand our offering and leverage the synergies that make our two companies leaders in the sector."

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff and supports clinical research for biotech clients from US, Europe and APAC.

The company has recently launched the GALEXI(TM) client portal, and has taken delivery of two more Sciex API 6500+(TM) LC-MS/MS systems. Key certifications include OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 20 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

About TetraQ www.tetraq.com.au

TetraQ is a Brisbane-based provider of bioanalytical and rodent toxicology and pharmacokinetics services for new drug and vaccine products. Our facility has NATA recognition for compliance with the OECD Principles of Good Laboratory Practice (GLP).

Our bioanalytical facility is located at the Royal Brisbane and Women's Hospital, and our in-life studies are run in a custom unit at the St Lucia campus of The University of Queensland. These two arms of TetraQ offer co-ordinated support for clients bringing pharmaceutical products to market.

TetraQ's bioanalytical facility determines small molecule and protein concentrations in matrices including plasma, serum, urine and tissue homogenates. We can develop and validate methods to support pharmacokinetic (PK) sample analysis for both pre-clinical and clinical studies.

We also offer pharmacodynamic (PD) analysis of biomarkers based on commercial ELISA kits or Meso Scale Discovery multiplex technology.

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

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HONG KONG, Mar 31, 2021 – (ACN Newswire) – Viva Biotech Holdings (1873.HK) announced that during the year ended December 31, 2020 (the "Reporting Period"), revenue of the Group increased significantly to RMB 697.0 million from RMB 323.1 million for the corresponding period last year, representing a YoY increase of 115.7%; gross profit increased substantially to RMB 304.9 million from RMB 155.9 million for the corresponding period last year, representing a YoY increase of 95.6%.

Financial Highlights of the year ended December 31, 2020:
— Revenue reached RMB 697.0 million, representing a year-on-year (YoY) increase of 115.7%
— Gross profit reached RMB 304.9 million, representing a YoY increase of 95.6%
— Adjusted non-IFRS net profit amounted to RMB 252.3 million
— Adjusted earnings per share amounted to RMB 0.18
— The Board recommended the payment of a final dividend of HK$0.01

Driven by the increase in outsourcing proportion of large-scale pharmaceutical enterprises and demand from small and medium-sized biotechnology companies, the global drug research and development ("R&D") and production service industry continued demonstrating an upbeat trend. Viva Biotech proactively grasped the opportunity and achieved both internal growth and external expansion. The synergistic effects of the Group's cash-for-service (CFS) model and equity-for-service (EFS) model were further demonstrated. The Group has thus made substantial progress in vertical integration and expansion along the industry chain to CDMO business.

Revenue from CFS Business Surged, Diversified & Extensive Customer Groups

During the Reporting Period, Viva Biotech's revenue from the CFS business increased significantly by 146.3% YoY to RMB 604.7 million. The total number of clients amounted to 1,252. The growth was primarily attributable to the extensive and diverse quality client groups, increase in orders from clients, and the CDMO and commercialization services due to acquisition of Langhua Pharmaceutical.

The backlog order under the CFS business model grew by approximately 54.7% and reached approximately RMB 416 million. As of December 31, 2020, the Company had accumulatively provided drug discovery services to over 543 biotechnology and pharmaceutical clients, delivered more than 21,000 protein structures and conducted R&D into over 1,500 independent drug targets. Clients included the global top 10 pharmaceutical companies (in terms of revenue in 2019) and 35 companies included in Fierce Biotech's Fierce 15. Revenue from repeated clients accounted for over 85% of the revenue during the Reporting Period.

Industry Chain Integration and Expansion of CDMO Business

Holding the aim to establish a one-stop platform from discovery to commercial production of novel drugs, the Company completed the strategic integration of Langhua Pharmaceutical in November 2020. As a comprehensive pharmaceutical R&D and manufacturing company, Langhua Pharmaceutical is mainly engaged in the production of small molecule APIs and intermediated and CDMO business. As of December 31, 2020, Langhua Pharmaceutical recorded revenue of RMB1,518.1 million throughout the year, representing a YoY increase of 22.7%. Sales revenue from its CDMO business amounted to RMB 875 million, representing a YoY increase of 54%. Langhua Pharmaceutical had served a total of over 709 clients, of whom the retention ratio of top ten clients reached 100%, and has independently produced 95 varieties of API and CDMO projects so far.

EFS Business Continuously Expanding, Portfolio Companies Made Substantial R&D Progress

During the Reporting Period, due to the increase in the incubated companies and their growing demands, revenue from the EFS business increased by 19.1% YoY to RMB 92.3 million, and backlog order climbed by approximately 138.8% YoY and reached approximately RMB 191 million. Throughout 2020, the Company reviewed a total of over 834 projects globally and added 21 start-ups to its portfolio companies, and added additional investment in 10 existing portfolio companies, covering multiple indications, modalities and locations. During the Reporting Period, R&D for all of the portfolio companies rolled out smoothly and total number of pipeline projects exceeded 120, half of which had entered PCC/IND-enabling stage. Meanwhile, the Company proactively carried out post-investment support, including enhancing talent recruitment, optimizing product pipeline development strategies, bridging financing resources and launching industry events such as Demo Day and Viva Biotech Partnership Summit, to develop and enhance ecosystem construction.

Enhancing Strengths of Technology Platforms, Expanding Scales of Staff and Facilities

During the Reporting Period, the Company invested RMB 66.0 million in R&D, representing a YoY increase of 46.7%. Besides the continuous optimization of existing technology platforms, the investment was primarily used for the introduction of new technology platforms, such as Cryo-EM and computational chemistry. The Company also actively expanded into the field of antibody macromolecules and set up CMC process development team, so as to take the initiative to expand and meet clients' demand for R&D and production services at various stages.

As of December 31, 2020, the Group had a total of 1,619 employees, including 643 employees newly consolidated from Langhua Pharmaceutical. The Company (excluding Langhua Pharmaceutical) had 976 employees, including 817 R&D personnel, with a laboratory and office premise of approximately 24,000 square meters. To better accommodate the rapid-growing business needs and personnel increase, save rental expenses and provide stable R&D, production and operation premises, the Company proactively expanded its business bases and obtained properties and land banks in Zhoupu, Shanghai; Zhangjiang, Shanghai; Chengdu, Sichuan; and Qiantang New District, Hangzhou.

Dr. Cheney Mao, Chairman and Chief Executive Officer of Viva Biotech Holdings, said, "Positioning at the early drug discovery sources from '0' to '1', the Company enjoys advantages in terms of technology platforms, client flow and talents. In the future, the Company will continue to construct and raise technology barriers, enhance talent recruitment, strengthen bridging of customers and portfolio companies, improve operating efficiency, tap into the synergistic effect, accelerate the construction of one-stop drug discovery and production service platforms from '0' to '1' and to 'N', to establish an open and cooperative platform targeting global biopharmaceutical innovators."

About Viva Biotech Holdings

Viva Biotech's mission is to become a cradle for innovative biotechnology companies from around the world. We have developed a scalable business model combing the conventional cash-for-service (CFS) model and its unique equity-for-service (EFS) model. Under the CFS model, the Group provides one-stop service for novel drug discovery and production to global pharmaceutical clients. EFS business is dedicated to investing globally in biotech innovation with novel solutions to unmet medical needs across multiple therapeutic areas. As of December 31, 2020, Viva Biotech had provided drug discovery and production services to 1,252 pharmaceutical clients worldwide, worked on over 1,500 independent drug targets, delivered approximately over 21,000 independent protein structures and incubated/invested 67 biotech companies.


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HONG KONG, Mar 24, 2021 – (ACN Newswire) – TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its audited annual results for the year ended 31 December 2020.

Milestones of 2020 Annual Results
TOT BIOPHARM's core products including mAb drug TAB008 and ADC drug TAA013 have achieved key milestones. The Company actively promoted the development of and collaboration relating to innovative drugs and have established a R&D and commercialization platform integrating mAb and ADC drugs. The Company will rapidly expand its CDMO/CMO business to create new momentum for the future development of the Company.

Key milestones of pipeline products:
— TAB008 (anti-VEGF mAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted, and was accepted by NMPA in September 2020 (Note: Pre-approval registration inspection was completed in January 2021). It is expected to be approved for marketing in 2021.
— TAA013 (anti-HER2 ADC): It is the first T-DM1 ADC product entering Phase III clinical trial in China. The first participant was enrolled in July 2020. Clinical recruitment is progressing smoothly.
— TAB014 (anti-VEGF mAb): Phase III clinical trial application (IND) was submitted to FDA. Upon receiving FDA's approval, it would be exempted from the Phase II clinical trial and would directly carry out Phase III clinical trial (Note: (IND authorized by FDA in January 2021, and would directly carry out Phase III clinical trial).
— TOZ309 (temozolomide capsule): Pre-approval registration inspection was completed, and it is expected to be approved for marketing in the first half of 2021.

Key milestones of commercial production plans
— In 2020, the construction of the ADC drug substance commercial production facility was completed, and the production of multiple batches of ADC drugs for clinical purposes was accomplished.
— In 2020, the GMP compliance inspection of the production workshop for chemical drugs was completed, laying a foundation for the commercial production of chemical drugs.

Dr. Liu, Jun, Chief Executive officer, Chief Scientific Officer, and Executive Director of TOT BIOPHARM, said, "TOT BIOPHARM has achieved multiple targets during the year, and manifested more prominent competitive and it has gradually formed a trend of coordinated development for R&D and commercial production of innovative drugs. In 2020, our R&D achievements are encouraging! The core product TAB008, TOT BIOPHARM's Independently developed bevacizumab biosimilar, has been submitted new drug application under the new version of the Administrative Measures for Drug Registration, and has been accepted by NMPA. Moreover, ADC drug TAA013 has successfully entered Phase III clinical trial, with a leading position in China in terms of our R&D progress. In the meantime, TOT BIOPHARM has established a R&D and commercialization platform integrating monoclonal antibodies (mAb) and antibody drug conjugates (ADC). In short, medium and long-term development, we will continue to enhance its production capacity planning and expand its CDMO/CMO business, so as to meet international and domestic clinical and commercial needs, and create new momentum for the future development of the Company. 2021 will be a fruitful year for TOT BIOPHARM, our core products TAB008 and chemical drug TOZ309, are expected to be approved for marketing, thereby benefiting a large number of cancer patients. We will continue to commit on our corporate vision of improving the quality of life of cancer patients worldwide with innovative technologies through the unremitting efforts."

Unique Business Models
— Our three integrated technology platforms and comprehensive industry chain
With three self-developed technology platforms and a complete international quality management system and registration team, TOT BIOPHARM has a comprehensive industry chain, covering from drug research and development, clinical research to commercial production, which lays a foundation for accelerating the progress of R&D, international market plan and CDMO business.
— Abundant Product Pipeline
At present, we have 13 drug candidates, including biological drugs, TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and antibody drug conjugates (ADC), TAA013 (anti-HER2 ADC), which are indicated for various cancers with high incidence, such as non-small-cell lung cancer, breast cancer, gastric cancer, esophageal cancer and cervical cancer.
— Commercial Production Layout with Competitive Edge
TOT BIOPHARM adheres to the business philosophy of the integration of innovative R&D and commercial production. The Company has a 16,000L capacity for mAb production and ADC drug substance production facility. In September 2020, the construction of drug substance production facility was completed for the commercial production of ADCs; the production workshop for chemical drugs has completed the GMP compliance inspection, which laid a foundation for the commercial production of chemical drugs.

The operations of the Company's various R&D pipelines proceeded hand-in-hand in 2020 and achieved smooth progress with the following major milestones.

Soon-to-be-commercialized Drugs
— TAB008 (anti-VEGF mAb) (Non-squamous non-small-cell lung cancer (nsNSCLC)): The new drug application was submitted under the new version of the Administrative Measures for Drug Registration, and was accepted in September 2020. It is expected to be marketed in 2021.
— TOZ309 (temozolomide capsules (200mg,100mg)): The temozolomide generic drug, a chemical drug, completed the pre-approval registration inspection, and it is expected to be marketed in the first half of 2021.
— TOM312 (megestrol acetate): We have completed the commercial-scale formulation process validation through continuous technological optimization, and have successfully submitted the ANDA application in Taiwan.

Clinical Trial Progress and Achievement
— TAA013 (anti-HER2 ADC) (HER2-positive breast cancer): Phase III clinical trials were initiated in June 2020 with the first patient enrolled in July, and it is currently at the stage of clinical recruitment. It is planned to be launch in the market in 2023.
— TAB014 (anti-VEGF mAb) (wet age-related macular degeneration (wAMD)): We have completed the pivotal Phase III clinical trials and CDE consultation, and directly carried out the Phase III clinical trials exempting from the domestic Phase II clinical trials. At the same time, we submitted the investigational new drug (IND) in respect of the Phase III clinical trial application of TAB014, based on the data from the Phase I clinical trial of TAB014 conducted in China and relevant clinical literature data, this IND application is a direct application for authorization to conduct Phase III clinical trial (being exempted from Phase II clinical trial).
— TIC318 (carboplatin) (epithelial-derived ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, testicular tumors, malignant lymphoma, cervical cancer, bladder cancer and NSCLC): We have completed commercial-scale formulation process validation in the high active drug injection workshop.

Commercial Production and CDMO/CMO Strategic Collaboration
TOT BIOPHARM increased resource investment, actively promoted CDMO/CMO business, and developed diversified strategic collaboration with domestic and foreign pharmaceutical companies to provide customers with high-standard and high-quality CDMO/CMO services.
— The Company's commercial production technology demonstrates a sharp competitive edge in cost effect. Its self-developed perfusion-batch combined process flows, PB-Hybrid Technology, can realize commercial production direct scale-up from 25L to 2,000L in the cell culture process, thereby streamlining process flows, reducing production risks while shortening production cycles, lowering production costs, and greatly improving production capacity and cost advantages.
— For the year of 2020, the Company has reached commercial collaboration with several innovative pharmaceutical companies to provide CDMO/CMO services for new drug R&D partners, including the CDMO collaboration with Kintor Pharmaceutical Limited (9939.HK) to continue providing clinical supplies manufacture and technical support for its core product Proxalutamide in China and the United States. At the same time, we provide Kintor clinical supplies manufacture for the novel coronavirus disease (COVID-19) overseas (including the United States, Brazil, etc.), pursues diversified collaboration opportunities while increasing the Company's cash flows.

Future Development
Embrace openness and win-win collaboration to promote domestic and international
commercial collaboration for drug candidates: At present, TOT BIOPHARM has multiple product pipelines such as biological drugs, ADC drugs and chemical drugs, which are stepping into the commercial stage with huge market potential. TOT BIOPHARM has been adhering to the principle of openness, collaboration and win-win, and discusses future commercial development strategies with various domestic and foreign partners. Relying on R&D, clinical trials and a one-stop full industry chain platform of application, manufacturing and commercialization, TOT BIOPHARM actively seeks the strategic collaboration domestically and internationally. We will obtain milestone funds through the transfer of domestic and foreign sales rights. Through diversified collaboration models, we share resources, accelerate the progress of product R&D and marketing, and rapidly occupy domestic and foreign market shares to enhance market competitiveness. Leveraging our unique advantages in R&D and production, we strengthen CDMO/CMO business collaboration to provide pharmaceutical companies with production capacity and technological requirements which they are lack of, and help customers shorten production time and reduce production costs in a cost-effective manner.

Financial Highlights
— Revenue amounted to RMB22,491,000, representing a 50% year-on-year decrease, mainly attributable to the impact of the national volume-based procurement policy on the sales derived from the distribution of brand-name drug S-1, and the alignment of our CDMO business with our customers' planned schedules.
— Research and development expenses amounted to RMB235,196,000, representing a 23% year-on-year increase, mainly attributable to the commencement of Phase III clinical trial for the TAA013 project of the Company in 2020 after the completion of Phase I clinical trial that resulted in an increase in demand for active pharmaceutical ingredients (APIs), excipients and consumables by related contract research (CROs) and those for the preparation of clinical drugs.
— Selling expenses amounted to RMB25,953,000, representing a 18% year-on-year decrease, mainly attributable to the overall economic slowdown as a result of the outbreak of COVID-19 in 2020 which led to the suspension or postponement of various marketing events.
— General and administrative expenses amounted to RMB46,855,000, representing a 51% year-on-year decrease, mainly attributable to the inclusion of listing expenses in the expenses for the same period in 2019.
— In summary, net loss for the year of 2020 amounted to RMB288,498,000, representing a 4% year-on-year decrease.

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)
TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumour drugs and therapies, striving to build a leading brand of oncology treatments worthy of the trust of patients and their families, and medical professionals.

The Company has in place three major integrated technology platforms. They are:

Therapeutic Monoclonal Antibody and ADC Technology Platform: it integrates research and development (R&D) and production capacities for antibody-based drugs and ADC, with the designed production capacity of the commercialization base of biological drugs reaching 16,000L to accommodate high-quality commercialization of drug candidates;

Gene Engineering Based Therapeutics Technology Platform: it integrates anti-tumour immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumour-targeted oncolytic virus products;

Innovative Drug Delivery Technology Platform: a comprehensive platform for the process development and commercial production of high intensity and frequency of drug injections. It adopts a production design with aseptic lyophilization and aseptic filling to satisfy the GMP production requirement of OEB 4/5 active level lyophilized powder and water needle.

Using these platforms, the Company has studied and developed various anti-tumour drug series and genres, and has formed a high quality and comprehensive drug product chain. On top of developing innovative proprietary drugs, the Company also draws on its own industry value chain to build a complete industry chain platform that supports operations from R&D and production and clinical development to marketing. By adopting an open platform business model, it is able to cooperate with biomedical enterprises and third parties at different stages along its industry value chain.

For enquiries:
Strategic Financial Relations (China) Limited
Anita Cheung / Winnie Lau / Christina Chong / Tin Tim
Tel: (852) 2864 4827 / 2864 4876/ 2864 4899 / 2114 4907
Email: sprg-tot@sprg.com.hk



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HONG KONG, Mar 23, 2021 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading and innovation-driven pharmaceutical conglomerate in the PRC, has announced its audited annual results for the year ended 31 December 2020. During the year, the Group switched marketing and sales resources towards new products by capturing opportunities arising from industry policies and boosted product sales by leveraging new online platforms. These efforts have brought about bountiful harvest, driving revenue from products that have been launched to market in the past three years to double to approximately RMB8.06 billion, and their contributions to total revenue jumping from 16.6% to around 34.1%.

Development Highlights
— Profit attributable to the owners of the parent was approximately RMB2.77 billion, while earnings per share were approximately RMB14.74 cents, representing modest increases of approximately 0.3% and 0.4% respectively over the last year amid adversity.
— Sales of new products launched within five years accounted for approximately 38.1% of the Group's total revenue, amounted to approximately RMB9.01 billion, an increase of approximately 79.3% over the last year. Cumulative revenue from 45 products that have been launched to market in the past three years has grown by over 100% compared with last year's level to around RMB8.06 billion, and their contributions to total revenue have also increased from 16.6% to about 34.1%.
— The oncology drug FOCUS V (Anlotinib) has been approved for three new indications, namely non-small cell lung cancer, small cell lung cancer and soft tissue sarcoma, and it has been included to the National Medical Reimbursement Drug List. The Group has formed a strong product mix with over 23 oncology products for various solid or haematological tumors. Oncology products of the Group have included more and more new products which have generated strong revenue, accounting for 40.3% of total revenue, and becoming the Group's most important product category.
— The Group made a capital contribution to Sinovac Life Sciences Co., Ltd. ("Sinovac LS") that amounted to US$515 million and becomes interested in a 15.03% equity interest in Sinovac LS. Sinovac LS has made significant progress in the phase III clinical trials of its inactivated COVID-19 vaccine and it has received orders from different countries, with a promising profitability outlook. The investment will help Sinovac enhance its R&D and production capabilities of CoronaVac, a COVID-19 vaccine. The investment also marks Sino Biopharm's foray into vaccine R&D and production.
— Penpulimab (Annike), an anti-PD-1 monoclonal antibody drug that is jointly developed by the Group and Akeso, Inc., for third-line treatment of metastatic nasopharyngeal carcinoma has gained fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA).
— In the fourth quarter, the Group obtained 12 approvals for drug registration and passed (or are deemed to have passed) Consistency Evaluations for 23 chemical drugs. The Group obtained a total of 35 approvals for new drug registration and passed the Consistency Evaluations for 47 chemical drugs during 2020.

Net profit grows amid adversity
During the year, the Group recorded revenue of approximately RMB23.65 billion (2019: RMB24.23 billion). Profit attributable to the owners of the parent was approximately RMB2.77 billion, while earnings per share were approximately RMB14.74 cents, representing modest increases of approximately 0.3% and 0.4% respectively over the last year amid adversity. The Group has maintained a healthy financial position with cash and bank balances reaching approximately RMB11.26 billion at the year end.

The Board of Directors declared a final dividend of HK2 cents per share. Together with the dividend of HK2 cents per share already paid in each of the first three quarters, the total dividends for the year amounted to HK8 cents per share (2019: 8 cents).

Promptly responds to COVID-19 pandemic fight
At the start of the COVID-19 pandemic, the Group, with its strong sense of social responsibility and high sensitivity, responded promptly and donated funds and materials to efforts aimed at controlling the pandemic. It made an emergency decision to add mask production lines and production of masks commenced to meet the urgent needs amid the pandemic. Since January 2020, the Group has made 18 donations of funds, drugs and materials involving a combined amount of RMB22 million. In addition, the Group resumed work and production as soon as possible while complying strictly with the government's COVID-19 prevention and control measures. While according high priority to the production of drugs that were urgently needed during the pandemic, the Group also strived to meet market demand for other general drugs.

By directing marketing and sales resources towards new products in response to policy changes, revenue from new products marketed over the past three years rises to account for around 34.1%
The Group addressed the impact of centralized drug procurement by switching marketing and sales resources towards new products that have been approved for launch in the last three years and carry significant academic value. Cumulative revenue from 45 products that have been marketed in the past three years has grown by over 100% compared with last year to RMB8.06 billion, and their contributions to total revenue have also enlarged from 16.6% to around 34.1%, which has partially mitigated the influence from old products due to the centralized drug procurement program.

As for the therapeutic categories, the oncology drug FOCUS V (Anlotinib) has been approved for three new indications, namely non-small cell lung cancer, small cell lung cancer and soft tissue sarcoma, and it has been included to the National Medical Reimbursement Drug List. The Group has formed a strong product mix with over 23 oncology products for various solid or haematological tumors. The Group's oncology products have included more new products which have generated strong revenue, accounting for 40.3% of total revenue, and becoming the Group's most important product category. The new respiratory drug Tianqingsuchang generated strong sales of over RMB500 million after it was launched to market more than six months ago and it is therefore worth looking forward to its higher revenue and profit contributions.

Promotes product sales with the use of new online platforms and achieves impressive results
Amid the pandemic, numerous academic exchanges and other forms of academic activities, organized in new online platforms, have brought about bountiful harvest. The Group actively explored and expanded investments in online marketing, academic activities and services. Nearly 80,000 different kinds of online academic activities were held for nearly 30 million customers and patients. The Group also strived to connect with and optimize sales terminals by working with over 60,000 pharmacies, which had served nearly 2 million patients. Its efforts successfully boosted product sales. Online marketing and academic services have since become an important part of the Group's sales and marketing operations.

Stepping up investment in R&D reaps bountiful harvest
For the year, the total R&D expenditure of approximately RMB2.85 billion, which accounted for approximately 12.1% of the Group's revenue. The Group's increase in investments in R&D has achieved fruitful results during the year.

During the fourth quarter, the Group was granted 5 clinical trial approvals, 12 production approvals, and 23 approvals for Consistency Evaluation, and made 6 clinical trial applications, 2 applications for Consistency Evaluation and 4 production applications. Cumulatively, a total of 391 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Out of these, 39 were for hepatitis medicines, 183 for oncology medicines, 22 for respiratory system medicines, 20 for endocrine, 16 for cardio-cerebral medicines and 111 for other medicines.

In 2020, the Group obtained 35 approvals for drug registration and 47 approvals for Consistency Evaluation. It submitted 41 applications for clinical trial, and completed production filing after clinical trials for 25 products. 12 applications for Consistency Evaluation were made. The Group obtained 191 patent approvals, including 158 invention patents. Cumulatively, the Group has obtained 924 invention patent approvals, making the Group the leading pharmaceutical company in China in terms of patent approvals.

Looking ahead: The Group will adopt marketing & sales and service model that employs online platforms
Looking forward to 2021, domestic supply and demand have rebounded strongly. After COVID-19 vaccines have been given conditional approvals for launch, vaccinations will provide major hope of containing the disease. With the increasing number of people around the world receiving COVID-19 vaccinations, the Group's investment in Sinovac LS, the vaccine manufacturer, stands to make attractive return.

The expansion of the centralized drug procurement scheme and its coverage has become a new normal in the domestic pharmaceutical industry, and consolidation in the industry will accelerate. Leading companies with a strong R&D capability, top R&D teams and product pipelines, leading technological platform, high technology barrier and the ability to produce new products continuously will enjoy distinct advantages. Noting the increasing importance of marketing and sales and service model that employs online platforms in the pharmaceutical industry, the Group has undertaken moves to keep abreast of these latest developments.

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 potentials, comprising a variety of biopharmaceutical and chemical medicines for treating tumors, liver diseases, orthopedic diseases, anti-infectious diseases and respiratory system diseases.

Sino Biopharm 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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