Ten Class 1 New Drugs Receive IND Approval in China, Including Candidates from Pfizer, HEC Pharm, Alphamab, and Huahai Pharma

According to the latest announcement on the official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration today, ten Class 1 new drugs have been approved for clinical trials. These investigational new drugs target various mechanisms, including TYK2 inhibitors, PI3K inhibitors, Bcl-2 inhibitors, and IL-17 antibodies, and are developed by companies such as Pfizer, HEC Pharm, Anon Therapeutics, Fuchuang Pharmaceutical, Keymed Biosciences, Huahai Pharmaceutical, and Jiangsu Hengrui Medicine.

▲Implied Approval for Clinical Trials (Data Source: CDE)

Pfizer: TYK2 Inhibitor PF-06826647 Tablets

PF-06826647 is a TYK2 inhibitor under development by Pfizer, currently in Phase 2 clinical trials. TYK2 is a member of the JAK family and plays a critical role in mediating IL-12, IL-23, and type I interferon signaling. According to Pfizer’s official website, the drug is intended for the treatment of inflammatory and autoimmune diseases. Recently, this product has received implicit approval for clinical trials in China, with the proposed indication being moderate-to-severe ulcerative colitis.

Arno Therapeutics: PI3K Inhibitor AN2025

AN2025 (buparlisib) is an oral pan-PI3K inhibitor that targets all Class I PI3K isoforms and exhibits immunomodulatory effects in cancer. Originally developed by Novartis, AnorMed obtained exclusive global rights to the drug in 2018 through a global licensing agreement. Based on previously completed global Phase II clinical trials, when used in combination with paclitaxel for patients with head and neck squamous cell carcinoma (HNSCC), the median survival time reached 10.4 months. Early studies also indicated that AN2025 holds therapeutic potential for tumors that are non-responsive or resistant to PD-1 inhibitors. Notably, the U.S. FDA has granted Fast Track designation for this drug. The recent approval of AN2025 for clinical trials in China aims to develop its indication for recurrent or metastatic head and neck squamous cell carcinoma.

Fuchuang Medicine: Bcl-2 Inhibitor FCN-338 Tablets

FCN-338 is a selective small-molecule inhibitor of Bcl-2. According to announcements from Fuchuang Pharmaceutical, the product was independently developed by the company, with cumulative R&D investment exceeding RMB 260,000. BCL-2, fully named B-cell lymphoma 2, plays a crucial role in apoptosis and is overexpressed in certain types of cancer, contributing to drug resistance. It represents a novel therapeutic target for hematologic malignancies. Bcl-2 inhibitors can restore the programmed cell death mechanism in tumor cells by inhibiting BCL-2 function, thereby inducing tumor cell death. FCN-338 has recently received implicit approval for clinical trials, intended for the treatment of hematologic malignancies.

Alphamab Oncology: Coagulation Factor Product KN057 Injection

KN057 is an innovative biologic drug targeting coagulation factors, developed by Alphamab Oncology based on protein engineering and antibody screening technologies, for the treatment of hematological disorders. The product has recently received implicit approval for clinical trials in China, with proposed indications being hemophilia A and hemophilia B, with or without inhibitors. Hemophilia is a rare inherited bleeding disorder characterized by a deficiency in coagulation factors, requiring long-term infusion of clotting factors.

Huahai Pharmaceutical: IL-17 Antibody HB0017 Injection

HB0017 is a monoclonal antibody targeting interleukin-17 (IL-17). It has previously received approval in China for the treatment of moderate-to-severe plaque psoriasis and ankylosing spondylitis. The indication for which it has now obtained implicit approval for clinical trials is psoriatic arthritis. Studies have shown that IL-17 is an important pro-inflammatory cytokine that plays a significant role in the pathological processes of various autoimmune diseases. Notably, this product was approved for clinical trials in the United States in April this year.

HEC Pharmaceutical: HEC89736 PTSA•0.5H2O Tablets, a PI3Kδ Inhibitor

HEC89736PTSA•0.5H2O is an oral, highly selective PI3Kδ inhibitor developed by HEC Pharm. Studies have shown that PI3Kδ plays a crucial role in regulating cells of the adaptive immune system as well as the innate immune system, making it a potential target for treating various immune disorders. The indications for which HEC89736PTSA•0.5H2O tablets have received implicit approval for clinical trials include hematologic malignancies such as chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma.

In addition, other Class 1 new drugs that have received implicit approval for clinical trials include: SHR-1703 injection, a novel biologic drug under Hengrui Medicine, intended for the treatment of eosinophilia-related diseases such as severe eosinophilic asthma; ST-1898 tablets, a Class 1 small-molecule chemical drug under Beijing Saitai Mingqiang Pharmaceutical, intended for the treatment of advanced solid tumors with c-MET abnormalities; WXFL10203614 tablets from Fuxin Pharmaceutical, intended for the treatment of moderate to severe active rheumatoid arthritis; and Xingmeng Biologics’ recombinant humanized monoclonal antibody injection against rabies virus, intended for post-exposure prophylaxis of rabies.

Original Title: Ten Class 1 New Drugs Approved for Clinical Trials, from Pfizer, HEC Pharm, Alphamab Oncology, Huahai Pharmaceutical, and Others

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