Innovation Pipeline Maturing: Hengrui Pharma Secures Clinical Approvals for Seven New Drug Candidates

　　【Pharmaceutical Network Corporate NewsBy 2025, Hengrui Pharma's innovative drugs have entered a period of intensive harvest. On December 29, Hengrui Pharma announced that its subsidiary, Hearm, had received the "Drug Clinical Trial Approval Notice" for HRS-6257 tablets issued by the National Medical Products Administration, and will soon commence clinical trials.
 

On the same day, the company also announced that it, along with its subsidiaries hearem, Shanghai Shengdi Pharmaceutical Co., Ltd., and Suzhou Shengdiya Biopharmaceutical Co., Ltd., had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for SHR-4375 Injection, Adebrelimab Injection, SHR-8068 Injection, Bevacizumab Injection, HRS-4642 Injection, and SHR-9839 Injection (sc).
 

It is reported that all the above drugs are in clinical phase I/II, and there is no complete clinical data yet. Except for HRS-6257 tablets, which are intended for the treatment of acute and chronic pain, the clinical positioning of the other drugs is oriented towards the anti-tumor field, involving advanced solid tumors, colorectal cancer, lung cancer, etc.
 

In fact, 2025 is a "big year" for Hengrui Pharma's innovative drug approvals. In the first three quarters, the number of new drug marketing applications accepted by the National Medical Products Administration (NMPA) has reached 13 in total (counted by indication), covering disease areas such as oncology, metabolism and cardiovascular diseases, immunology, and respiratory diseases. During the reporting period, the company also obtained 48 clinical trial approvals, with four products included in the list of breakthrough therapies.
 

Currently, Hengrui Pharma has a robust pipeline with over 100 self-innovated products in clinical development and more than 400 clinical trials being conducted both in China and internationally. Notably, its solid innovation and R&D capabilities have also laid a strong foundation for the company’s performance growth and high-level international collaborations.
 

In terms of performance, in the first three quarters of this year, the company achieved operating revenue of 23.188 billion yuan, representing a year-on-year increase of 14.85%; net profit attributable to shareholders was 5.751 billion yuan, marking a year-on-year growth of 24.50%.
 

In terms of BD transactions, in March, Hengrui Pharma announced an exclusive licensing agreement with Merck regarding its Lipoprotein(a) [Lp(a)] oral small molecule project (including the lead compound named HRS-5346), with a total value of $1.97 billion. In April, Hengrui Pharma announced a collaboration with Merck, granting Merck the exclusive commercial rights in mainland China for its self-developed Class 1 new drug HR7280; Hengrui Pharma will receive an upfront payment of €15 million (approximately RMB 120 million) and is also entitled to receive milestone payments for the licensed product and royalties of a double-digit percentage of annual net sales in the licensed territory. In July, Hengrui Pharma reached a collaboration with GSK to jointly develop up to 12 innovative drugs covering respiratory, autoimmune, inflammation, and oncology fields (including the authorization of HRS-9821 outside Greater China), with a potential total transaction amount of approximately $12 billion...
 

Overall, Hengrui Pharma has entered the harvest period of innovation. In the future, the company will be driven by "independent research + BD + internationalization" to continuously consolidate its leading position in the field of oncology, while achieving more new breakthroughs in metabolism, immunity and other fields.
 

　　Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.