Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors.

In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies.

Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively inhibiting and capturing PARP, thereby triggering cell death. PARP inhibitors have been proven to be effective in treating breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer. However, the clinical application of PARP inhibitors is affected by drug toxicity and the development of drug resistance after long-term use. Therefore, exploring new PARP inhibitors and combination treatment options may provide more treatment options for patients with advanced solid tumors.

HRS-1167 (M9466) is a selective, highly active, orally available small molecule inhibitor of PARP1 independently developed by Hengrui and has intellectual property rights. It is a second-generation PARP inhibitor. Compared with first-generation PARP inhibitors, HRS-1167 (M9466) is more selective and has stronger affinity for PARP1 and can induce DNA capture. HRS-1167 (M9466) is currently in early clinical development and has the potential to treat additional patients as monotherapy and combination therapy if it demonstrates favorable safety and efficacy.

SHR-A1921 for injection is an antibody drug conjugate (ADC) independently developed by Hengrui Pharmaceuticals that targets the TROP-2 tumor-related antigen. By binding to the target antigen on the surface of tumor cells, the drug is endocytosed into the cells and released into small cells. Molecular toxins kill tumor cells. In April 2023, Hengrui disclosed clinical trial data targeting SHR-A1921 for the first time at the AACR 2023 meeting, and the results were encouraging. In addition to this approval, a number of phase I-III clinical studies have been carried out, covering advanced solid tumors.

Bevacizumab is a humanized anti-VEGF monoclonal antibody that blocks tumor angiogenesis and inhibits tumor cell growth by blocking the binding of VEGF to its receptor. Hengrui's Bevacizumab Injection is a product independently developed and applied for marketing in accordance with the biosimilar route, using the original bevacizumab as a reference drug. Currently, Hengrui Medicine’s bevacizumab injection (trade name: Arritus®) has been approved for 3 indications. In June 2021, it was approved for metastatic colorectal cancer and advanced, metastatic or recurrent cancer. Non-small cell lung cancer; the third indication was approved in September 2021 for recurrent glioblastoma. Studies have shown that PARP inhibitors and anti-angiogenic drugs can have synergistic anti-tumor effects.

Abiraterone acetate tablets (II) (trademark: EREGIS®) is a Class 2 new drug independently developed by Hengrui Pharmaceuticals. It is also the first abiraterone acetate nanocrystal preparation in China. It innovatively introduces nanocrystal technology and absorption enhancers. 8-(2-Hydroxybenzamido)sodium octanoate significantly improves bioavailability and reduces the impact of food. It can be taken on an empty stomach or after meals, which is beneficial to improving the patient's compliance with long-term treatment. The drug has been approved for marketing in December 2023, bringing new treatment options to domestic patients with metastatic prostate cancer.

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