Two Drugs Enter Clinical Trials, One Approved for Market: Pfizer's GDF15 Monoclonal Antibody, Qilu's AB-729, and Hengrui's Omega-3 Fatty Acid Capsules

According to announcements from various companies and information from the CDE official website, two drugs have applied for clinical trials, and one drug has been approved for marketing! They are Pfizer's GDF15 monoclonal antibody Ponsegromab Injection, Qilu Pharmaceutical’s AB-729 Injection (introduced for $285 million), and Hengrui Medicine’s ω-3 Fatty Acid Ethyl Ester 90 Soft Capsules.

Two Drugs Submitted for Clinical Trials

Pfizer's GDF15 Monoclonal Antibody Submits for Clinical Trial

The CDE official website shows that Pfizer's Ponsegromab Injection clinical trial application has been accepted. This is the first GDF15 monoclonal antibody to be declared for clinical trials in China and can be used to treat cancer cachexia, solid tumors, anorexia, heart failure, etc.

Ponsegromab is currently primarily developed for the treatment of cancer cachexia. It is a secondary reaction mainly caused by tumor cell products and cytokines released by the body, characterized by systemic metabolic disorders, presenting symptoms such as anorexia, weight loss, anemia, weakness, and exhaustion.

GDF15 (Growth Differentiation Factor 15) is an endocrine hormone that binds to the GFRAL receptor in the brain, leading to reduced food intake and weight loss in the body. Ponsegromab, as a GDF15 monoclonal antibody, exerts its therapeutic effect by blocking the binding of GDF15 to the GFRAL receptor.

Qilu Pharmaceutical's AB-729 Injection, Acquired for $285 Million, Submits Clinical Application in China

The CDE official website shows that the clinical trial application of AB-729 Injection, developed by Qilu Pharmaceutical/Arbutus, has been formally accepted by the National Medical Products Administration (NMPA). Public information indicates that AB-729 is an RNAi drug developed by Arbutus for the treatment or prevention of hepatitis B.

RNA Interference (RNAi) is a mechanism present in living cells that suppresses the expression of specific genes, thereby affecting the production of specific proteins. AB-729 is an RNAi drug targeting liver cells, utilizing Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology, and can be administered via subcutaneous injection.

One Drug Approved for Marketing

Hengrui Medicine's Omega-3 Fatty Acid Drug for Hypertriglyceridemia Approved for Marketing in China

According to Hengrui Medicine's official WeChat, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, has received the "Drug Registration Certificate" issued by the National Medical Products Administration, approving the company's ω-3 Fatty Acid Ethyl Ester 90 Soft Capsules for market launch. The drug is indicated for use in adult patients with severe hypertriglyceridemia (≥500mg/dL) to reduce triglyceride (TG) levels on the basis of dietary control.

The main components of ω-3 Fatty Acid Ethyl Esters 90 Soft Capsules are Eicosapentaenoic Acid Ethyl Ester (EPA) and Docosahexaenoic Acid Ethyl Ester (DHA). Since EPA and DHA are weak substrates for the enzymes responsible for triglyceride synthesis, and they inhibit the esterification of other fatty acids, this product can reduce the synthesis of triglycerides in the liver. ω-3 Fatty Acid Ethyl Esters 90 Soft Capsules are suitable for reducing triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) on the basis of dietary control.

Editor: Qijin

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