Another Triumph in Tasly Biopharma Innovative Drug R&D — PCSK9 Monoclonal Antibody Approved for Clinical Trials

Another Triumph in Tasly Biopharma Innovative Drug R&D — PCSK9 Monoclonal Antibody Approved for Clinical Trials

On May 6, 2020, Tasly Biopharmaceuticals Co., Ltd. (hereinafter referred to as “Tasly Biopharma”), a holding subsidiary of Tasly Pharmaceutical Group Co., Ltd., received clinical trial approval by National Medical Products Administration (NMPA) for its recombinant fully human anti-PCSK9 monoclonal antibody injection.

As a biopharmaceutical company that has been concentrating on cardiovascular and cerebrovascular field for 19 years, Tasly Biopharma’s recombinant fully humani anti-PCSK9 monoclonal antibody injection is a Class 1 new therapeutic biological product that specifically binds to PCSK9 (Proprotein Convertase Subtilisin /Kexin Type 9) for effectively inhibiting the functions of PCSK9 and reducing the level of low density lipoprotein cholesterol (LDL-C) in plasma. It is used for the treatment of hypercholesterolemia, especially in patients who cannot receive statins for intolerable side effects and patients whose LDL-C level is still not normalized after treatment with statins at maximum acceptable dose, thereby significantly reducing the incidence and death risks of atherosclerotic cardiovascular disease (ASCVD).

According to the data in the “Report on Cardiovascular Diseases in China 2018”, the prevalence of dyslipidemia in Chinese people over 18 years old in 2012 was 40.40%, and the prevalence of dyslipidemia in Chinese adults has risen sharply in the past decade. In 2011, the survey on the management of dyslipidemia patients and cholesterol compliance in China showed that only 39% of dyslipidemia patients received lipid-lowering treatment, most of whom used statins. 38.5% of patients receiving lipid-lowering drugs did not reach the target value of LDL-C.

Currently, there are only two PCSK9 inhibitor drugs in the world that have been approved for sales in the market, Evolocumab and Alirocumab. In China, related approved products include Evolocumab injection and Alirocumab injection. Therefore, the development of recombinant fully human anti-PCSK9 monoclonal antibody injection helps to meet the current clinical needs.

Tasly Biopharma will carry out clinical trials in strict accordance with the drug clinical trial notification and related laws and regulations. After the clinical trial is completed, we will submit a new drug production application based on the results of the clinical trial statistical data, in order to finally obtain the production approval and market it for the wellbeing of more patients across the world.

Founded in 2001 as a pioneer deeply rooted in the fast growing biologics market in China, Tasly Biopharma is a leading innovative biopharmaceutical company in China with over 19 years’ rich experience in autonomous R&D and commercialization of biological medicine. We operate one of the few commercialization platforms in the industry which integrates the research and development, manufacturing, and sales of biological medicine.

Establishing a complete biological drug research and development system, Tasly Biopharma has always attached great importance to research and development innovation, focused on the three major therapeutic areas of cardiovascular diseases, alimentary tract and metabolism, and oncology, and continuously and steadily increased investment in research and development to lay a good foundation for future development.

Tasly Biopharma continues to develop a complete product pipeline system, and currently has a portfolio of 17 pipelines under research. It includes one class Ⅰ innovative biologic thrombolytic drug PUK on the market, one product in Phase III trial, three products in Phase II trial, two products in Phase I trial and ten pre-clinical products, which make up a preferred product portfolio capable of continuous development. PUK, which is the only approved recombinant human prourokinase product in China, was included in the “Catalog of Medicines” covered by National Medical Insurance System twice in 2017 and 2019. PUK is the first Category I biological drug approved in China to have received funding under the National Science and Technology Major Project — Major Innovative Drug Development during the 11th Five-Year Plan period. We believe that PUK has huge potential to become a blockbuster thrombolytic drug in China. Its new indication for acute ischemic stroke has completed clinical enrollment in Phase III, and its NDA filing is likely to be made this year; another new indication for acute pulmonary embolism has completed phase II clinical enrollment.

In addition, the fully-human EGFR-targeted monoclonal antibody SY101 for the treatment of advanced colorectal cancer and hepatitis B adenovirus injection T101 for treatment have both started phase II clinical trials; the recombinant oncolytic virus injection T601 has started phase I clinical trials this year. B1140 and SY101 received funding under the National Science and Technology Major Project — Major Innovative Drug Development during the 13th Five-Year Plan period at the same time.

Tasly Biopharma has always focused on biotechnology with patients as the center, aiming to provide high-quality and cost-effective biologic drugs for global patients, and meeting the growing unfulfilled clinical needs in the target therapeutic area.