Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study.

In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise.

Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays an important role in maintaining gene stability and telomere length. It has been found that PARP inhibitors can hinder DNA damage repair by selectively inhibiting and trapping PARP, thus triggering cell death.PARP inhibitors have been proven to be effective in the treatment of breast, ovarian, prostate, and pancreatic cancers, but the clinical application of PARP inhibitors is affected by the toxicity of the drug and the emergence of resistance to long-term use. Therefore, exploring novel PARP inhibitors and combination therapeutic regimens may provide more therapeutic options for patients with advanced solid tumors.

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

SHR-A1921 for injection is Hengrui Pharmaceuticals' self-developed antibody-drug coupling (ADC) targeting TROP-2 tumor-associated antigen, which kills tumor cells by binding to the target antigen on the surface of the tumor cell, allowing the drug to be endocytosed into the cell and then releasing a small molecule toxin to kill the tumor cell.In April 2023, Hengrui Pharmaceuticals disclosed the first clinical trial data of the targeting of SHR-A1921 in the AACR 2023 meeting. A1921 clinical trial data with encouraging results. In addition to this approval, a number of Phase I-III clinical studies have been conducted covering advanced solid tumors.

Bevacizumab is a humanized anti-VEGF monoclonal antibody, which blocks tumor angiogenesis and inhibits tumor cell growth by blocking the binding of VEGF to its receptor. Hengrui Pharmaceuticals Bevacizumab Injection is a product independently researched and developed according to the biosimilar pathway, using the original bevacizumab as the reference drug. Currently, Hengrui Pharmaceuticals Bevacizumab Injection (trade name: Eritol®) has been approved for 3 indications, in June 2021 for metastatic colorectal cancer and advanced, metastatic or recurrent non-small-cell lung cancer; and in September 2021 for the third indication, for recurrent glioblastoma. Studies have shown that PARP inhibitors and anti-angiogenic agents can have synergistic anti-tumor effects.

Abiraterone Acetate Tablets (Ⅱ) is a Class 2 new drug independently developed by Hengrui Pharmaceuticals, and is also the first nanocrystalline formulation of Abiraterone Acetate in China, which innovatively introduces nanocrystalline technology and pro-absorbent agent 8-(2-hydroxybenzamido)octanoic acid sodium, which significantly improves the bioavailability and reduces the influence of food, and can be taken on an empty stomach or after meals, which is conducive to improving the patient's long-term treatment adherence. Adherence. The drug has been approved for marketing in December 2023, bringing new treatment options for metastatic prostate cancer patients in China.

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