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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SHANGHAI, CHINA, Mar 19, 2021 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the audited annual results of the Company and its subsidiaries for the year ended December 31, 2020 (the "Reporting Period"). During the Reporting Period, the Company continued to advance various clinical trials and R&D investments, successfully completed two Phase III registration trials for dorzagliatin in China, and achieved remarkable results in preparing for dorzagliatin's commercialization. These 2020 achievements provide a solid foundation for the Company's long-term and stable development in the future. In 2020, the Company incurred approximately RMB367 million in total expenditures, of which approximately RMB221 million was research and development expenses. As of December 31, 2020, the Company's cash position was approximately RMB1,032 million, a decline of only RMB74 million from the 2019 year-end cash balance of RMB1,106 million, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.

Over the past decade, Hua Medicine has focused on unmet medical needs and relentlessly pursued breakthroughs in a major disease area, successfully realizing the world's leading scientific concept into the first-in-class oral glucokinase activator, dorzagliatin, with a breakthrough innovation mechanism. With the successful completion of two registration trials, dorzagliatin's scientific thesis of "Repairing sensors, reshaping homeostasis and fundamentally treating diabetes" has been validated. Hua Medicine has become the first company in the world to complete clinical development of a glucokinase activator. The results of the two Phase III clinical trials demonstrated that dorzagliatin has long-term sustained efficacy, and good safety and tolerability profiles. By repairing the damaged expression of glucokinase in patients with diabetes, dorzagliatin has the potential to improve beta-cell function, reduce insulin resistance and ultimately restore the self-regulation of blood glucose. Dorzagliatin has progressed from 0 to 1 – from a disruptive scientific theory to a potential commercially viable product, propelling Hua Medicine into a new stage of development.

The unique mechanism of dorzagliatin is also expected to create a new era of personalized and precision treatment of diabetes. Results from two Phase I clinical trials, HMM0111 and HMM0112, announced in the first half of 2020 demonstrated that dorzagliatin combined with DPP-4 inhibitors and SGLT-2 inhibitors, respectively, have a clear synergistic effects in blood glucose control, indicating that dorzagliatin has a wide range of application potential in Type 2 diabetes ("T2D") patients with different glucose control needs and at different disease stages. Meanwhile, data from HMM0111 also indicated that dorzagliatin can promote endogenous GLP-1 secretion and improve beta-cell function in patients (specific research results will be presented at this year's ADA Scientific Sessions). In addition, a Phase I study in patients with end stage chronic kidney disease demonstrated that dorzagliatin is a feasible monotherapy for T2D patients who have diabetic kidney disease ("DKD"), who make up about 20% to 40% of T2D patients. This marks the first oral anti-diabetes therapy that could be available for this group of T2D patients, as current oral therapy are either prohibited or require dose adjustment. The Company will initiate additional clinical trials for dorzagliatin in DKD, and combination therapy with additional diabetes drugs, including with GLP-1 RAs and insulin for T2D patients, and with insulin for T1D patients, to expand the addressable market for dorzagliatin. The Company will also continue to expand in three dimensions: expansion of product pipeline, expansion to global, and expansion into new disease areas to take Hua Medicine from 1 to 10. These will support Hua Medicine in becoming a leading biotechnology company with clinical value, social value and investment value.

"In 2020, we experienced the most serious global public health crisis in a century. Despite the pandemic Hua Medicine has still achieved several milestones and breakthroughs in clinical trials and in the prepartion for drug commercialization. We have completed relevant preparation work and will submit the New Drug Application ("NDA") to the National Medical Products Administration ("NMPA") very soon. We hope to work with our partners to further accelerate the NDA and marketing processes of dorzagliatin for the benefit of diabetes patients in China and around the world." said Dr. Li Chen, founder, CEO and CSO of Hua Medicine.

2020 Clinical Highlights:
– Successfully completed SEED, a Phase III registration trial to investigate the efficacy and safety of dorzagliatin monotherapy in drug naive T2D patients. It was the first Phase III trial conducted by Hua Medicine in China. The 52-week topline data demonstrated that dorzagliatin as a monotherapy has long-term sustained efficacy, and good safety and tolerability profiles.
– Successfully completed DAWN, a Phase III registration trial to investigate the combination therapy of dorzagliatin and metformin on T2D patients inadequately glycemic-controlled with metformin. It is the second Phase III trial conducted by Hua Medicine in China. Both the 24-week and 52-week topline results demonstrated that the combination therapy has long-term sustained efficacy, and good safety and tolerability profiles.
– Presented additional data of the 24-week SEED trial at the 80th American Diabetes Association (ADA) Annual Scientific Sessions, demonstrating significant improvements in beta-cell function and 2h-PPG reduction.
– Announced additional data of the 24-week DAWN trial at the Chinese Diabetes Society's 2020 Scientific Meeting, demonstrating improvements in beta-cell function and reduction in insulin resistance.
– Completed HMM0110, which demonstrated desirable pharmacokinetics profile in patients with end stage chronic kidney disease, indicating the potential use of dorzagliatin with no dose adjustment among T2D patients with diabetic kidney disease.
– Completed HMM0111, investigating the pharmacokinetic and pharmacodynamic parameters of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function, in addition to increased secretion of endogenous GLP-1.
– Completed the clinical trial of HMM0112, investigating the pharmacokinetic and pharmacodynamic characteristics of dorzagliatin in combination with empagliflozin (a SGLT-2 inhibitor) and demonstrated a clear synergistic effect in efficacy of blood glucose reduction and improvement of beta-cell function.

Operational highlights:
– Entered into a commercialization agreement and strategic partnership with Bayer AG for dorzagliatin in China.
– Entered into a commercial supply agreement with Raybow Pharmaceutical, for Raybow to become an additional manufacturing supplier for commercial launch.
– Granted the Drug Manufacturing Permit for dorzagliatin in China by the Shanghai Municipal Drug Administrative Bureau.
– Announced that global operation headquarters and research and development center in Shanghai's Zhang Jiang Science City officially established.

Financial Highlights: For the year ended December 31,2020
– Cash position was approximately RMB1,032 million, representing a decline of only RMB 74 million from the 2019 year-end cash balance, due principally to the inflow of non-dilutive upfront payment by Bayer AG of RMB 300 million.
– Total expenditures incurred by the Company was approximately RMB367.2 million, of which approximately RMB221.0 million was research and development expenses, representing a decrease of approximately 31% (RMB101 million).
– Loss before tax decreased by approximately RMB32.1 million or approximately 8% to approximately RMB393 million.
– Loss and total comprehensive expense for the year decreased by approximately RMB31.7 million or approximately 7% to approximately RMB393.6 million.

Business Outlook
– Plan to submit our NDA for dorzagliatin to the NMPA in China in the first half of 2021.
– Plan to initiate additional studies for dorzagliatin in DKD in the second half of 2021.
– Plan to initiate additional studies for dorzagliatin combinations, including with GLP-1 RAs and insulin for T2D patients, and insulin for T1D patients in the second half of 2021. Advancing the company fixed-dose combination pipeline for dorzagliatin.

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 will submit its NDA 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-enabling 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.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
Email: ir@huamedicine.com

Media
Email: pr@huamedicine.com

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