Hengrui Medicine Advances Four Innovative Drugs; Class 1 New Drug Wins NMPA Approval

After the market close on August 20, Hengrui Medicine issued four announcements stating that its self-developed Class 1 innovative drug fumarate liconpam (HRS-5965) capsules had received marketing approval from the National Medical Products Administration (NMPA), while three other innovative drugs — SHR-8203 injection, SHR-7012 injection, and HRS-3095 tablets — each received clinical trial approval notices.

According to the announcements, fumarate liconpam capsules are a Class 1 chemical drug in a 25mg specification, indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy. PNH is an acquired hemolytic disease that has been included in China's First Batch of Rare Disease Catalog. The drug is a complement factor B inhibitor that suppresses both intravascular and extravascular hemolysis at the mechanistic level by inhibiting abnormal activation of the alternative pathway and the complement amplification loop.

For this indication, Novartis's Fabhalta (iptacopan hydrochloride capsules) was approved in China in 2024, while Langlai Technology's Yishining (lanopam hydrochloride tablets) and Haisco's Youkepan (sipam succinate tablets) received approval in 2026. According to the EvaluatePharma database, Fabhalta's global sales reached approximately USD 505 million in 2025. Hengrui's marketing application for the drug in PNH patients who remain anemic after prior treatment with C5 complement inhibitors is also under review. To date, cumulative R&D investment in the fumarate liconpam capsule program totals approximately RMB 277.5 million (unaudited).

Subsidiary Guangdong Hengrui Medicine Co. , Ltd. received a clinical trial approval notice from the NMPA for SHR-7012 injection, a self-developed innovative drug intended for the treatment of cutaneous lupus erythematosus (CLE). Its clinical trial application was accepted on May 21, 2026. No drug targeting the same mechanism has been approved domestically or internationally to date. Cumulative R&D investment in the SHR-7012 injection program totals approximately RMB 25.5 million (unaudited).

Another clinical trial approval was granted for SHR-8203 injection, filed by subsidiary Beijing Shengdi Pharmaceutical Co. The self-developed innovative anti-tumor drug is intended for the treatment of advanced solid tumors. Its clinical trial application was accepted on May 28, 2026, and the NMPA has approved monotherapy clinical trials in advanced solid tumors. No similar drug has been approved domestically or internationally, and cumulative R&D investment in SHR-8203 injection totals approximately RMB 20.4 million (unaudited).

Subsidiary Chengdu Shengdi Pharmaceutical Co. also received a clinical trial approval notice from the NMPA for HRS-3095 tablets, authorizing clinical trials for primary immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA). HRS-3095 is a small-molecule compound targeting immune cells developed in-house, with promising therapeutic effects on autoimmune blood diseases. Its clinical study for chronic spontaneous urticaria is progressing to Phase II. No drug targeting the same mechanism has been approved domestically for ITP and AIHA to date. Cumulative R&D investment in the HRS-3095 tablet program totals approximately RMB 39.6 million (unaudited).