Hengrui Pharmaceutical (01276): Drug clinical trial approval notice for drugs such as HRS-7172 tablets and adbelimab injections

Zhitong Financial App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) and its subsidiaries received approval from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to issue HRS-7172 tablets, adbelizumab injections, 4610 injections, SHR-8068 injections, SHR-9839 (sc), injectable SHR-9839 (sc), injectable SHR-1826, bezubasumab injections, HRS-4642 injections, HRS-4642 injections, HRS-4642 injections HRS -7058 capsules of the “Drug Clinical Trial Approval Notice” will conduct clinical trials in the near future.

HRS-7172 tablets are novel anti-tumor small molecule inhibitors independently developed by the company. According to inquiries, there are currently no similar drugs approved for marketing in China. Up to now, the total R&D investment for HRS-7172 film-related projects is about 61.9 million yuan (unaudited).

Adbelimab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance by specifically binding PD-L1 molecules and reactivate the anti-tumor activity of the immune system, thus achieving the goal of treating tumors. The company's adbelizumab injection has been approved for two indications: first-line treatment of patients with extensive small cell lung cancer in combination with carboplatin and etoposide; combined with platinum-containing chemotherapy as a new adjuvant treatment, and continued to use this product as a single adjuvant treatment after surgery to treat patients with stage II, IIIA, and IIIB that can be surgically resected and without known EGFR (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangement. Similar foreign products Atezolizumab (product name: Tecentriq), Avelumab (product name: Bavencio), and Durvalumab (product name: Imfinzi) have been approved for sale in the US. Among them, Atezolizumab and Valumab have been approved for sale in China. A number of similar products have also been approved for sale in China. According to inquiries, total global sales of Atezolizumab, Avelumab, and Durvalumab in 2025 were approximately US$11.054 billion. Up to now, the total R&D investment for adbelimab injection-related projects is about 1,309 billion yuan (unaudited).

SHR-4610 injection is an innovative anti-tumor drug independently developed by the company. It has shown good anti-tumor activity in pre-clinical animal models and is intended for the treatment of advanced solid tumors. Up to now, the total R&D investment for SHR-4610 injection-related projects is about 15.5 million yuan (unaudited).

SHR-8068 injection is an all-human anti-CTLA-4 monoclonal antibody introduced by the company, which can enhance anti-tumor immune effects. The project has advanced to phase III clinical trials of multiple combination drugs for liver cancer and lung cancer. Currently, two similar products have been approved for marketing worldwide, namely ipimumab and teximumab. According to inquiries, the total global sales volume of ipimumab and teximumab in 2025 is approximately US$1.68 billion. Up to now, SHR-8068 injection-related projects have invested a total of about 510 million yuan in R&D (unaudited).

SHR-9839 is an EGFR/c-Met bispecific humanized antibody drug independently developed by the company. It is intended to treat advanced solid tumors. It exerts an anti-tumor effect by simultaneously blocking two key signaling pathways related to tumor development. SHR-9839 (sc) for injection is a subcutaneous preparation of SHR-9839. Currently, 1 drug with the same target has been approved for marketing worldwide. Up to now, the total R&D investment for SHR-9839 related projects is about 124 million yuan (unaudited).

Injectable SHR-1826 is an antibody-conjugated drug targeting c-Met. It kills tumor cells after being endocytosed into tumor cells through specific binding to target antigens on the surface of tumor cells. Currently, clinical trials of this project for non-small cell lung cancer have progressed to phase III. According to inquiries, the similar product ABBV-399 (generic name: telisotuzumab vedotin) obtained accelerated approval from the US FDA for marketing in May 2025. Up to now, the total R&D investment for SHR-1826 related projects for injectable use is about 170 million yuan (unaudited).

Bevacizumab is a humanized anti-VEGF monoclonal antibody. It was developed by Chinese and foreign pharmaceuticals in collaboration with Genetech, a subsidiary of Roche. It was approved for marketing in the US in 2004. The trade name is Avastin (Avastin), and is currently sold in China and many countries around the world. The company's bevacizumab injection is a biosimilar of Anvitin and was approved for marketing in 2021. Currently, several bevacizumab injections have been approved for marketing in China. According to inquiries, the global sales volume of bevacizumab in 2025 is about US$5.86 billion. Up to now, bevacizumab injection-related projects have invested about 413 million yuan in R&D (unaudited).

HRS-4642 injection is a KRAS G12D inhibitor independently developed by the company. It is a liposomal dosage form. This product can specifically bind KRAS G12D, inhibit the phosphorylation of MEK and ERK proteins, and exert anti-tumor effects. According to inquiries, there are currently no similar drugs approved for marketing at home or abroad. Up to now, HRS-4642 injection-related projects have invested about 349 million yuan in R&D (unaudited).

HRS-6093 tablets are a novel, efficient, and selective oral KRAS G12D inhibitor, which can specifically bind KRAS G12D mutant protein to exert anti-tumor effects. According to inquiries, no similar products have been approved for sale at home or abroad. Up to now, HRS-6093 film-related projects have invested a total of about 60.2 million yuan in R&D (unaudited).

HRS-7058 is a novel, efficient, and selective small-molecule covalent inhibitor intended to treat advanced solid tumors with KRAS G12C mutations. Globally, similar products Sotorasib and Adagrasib were approved by the FDA for marketing in 2021 and 2022, respectively. Currently, 4 similar products have been approved for marketing in China, including Fluozelese (approved in 2024), Gesorese (approved in 2024), Golerese (approved in 2025), and Sausi Merese (approved in 2026). According to the EvaluatePharma database, the total global sales volume of similar products over 2025 is approximately US$619 million. Up to now, the total R&D investment for HRS-7058 related dosage forms is about 197 million yuan (unaudited).