The board of directors of Sino Biopharmaceutical Limited announced that the Anlotinib Hydrochloride Capsules and Anti PD-L1--Benmelstobart developed by Chia Tai Tianqing Pharmaceutical Group Co. Ltd., a subsidiary of the Company, have filed a new indication application for marketing to the Center for Drug Evaluation (theCDE) of the National Medical Products Administration (the NMPA) of China and the application is accepted, for the indication of recurrent or metastatic endometrial cancer that is not microsatellite instability-high (non-MSI-H) or not DNA mismatch repair deficient (non-dMMR) and that has been previously treated by a first or second line chemotherapy regimen that was either unsuccessful or not tolerated. Benmelstobart is a novel fully humanized anti PD-L1 monoclonal antibody with a new sequence self-developed by the Group.

In April 2022, Benmelstobart in combination with Anlotinib Hydrochlorides Capsules was included in the breakthrough therapy category by the CDE for the treatment of recurrent or metastatic endometricrial cancer. In January 2023, the new drug application for Benmelstobart was formally accepted by the CDE for first-line treatment of small cell lung cancer in combination with AnlotinIB Hydrochloride Capsules. In January 2024, Benmelstobart In combination with Anlotinib hydrochloride Capsules was included in priority review and approval procedures of the CDE for the treatment the recurrent or metastatic endomet Industrial cancer.

Anlotinib HydrochlorIDE Capsules is a novel oral small molecule multi-targeted tyrosine kinase inhibitor (TKI) independently developed by the Group. In May 2018, Anlotinib Hydrochloriding Capsules was approved for marketing by the NMPA and was the first drug approved for utilisation in the third-line treatment of advanced non-small cell lung cancer in China. In January 2023, Anlotinib Hydro chloride Capsules' application for marketing of its sixth indication was formally accepted by the CD E for use in conjunction with Benmelstobart for the first-line treatment of small cells lung cancer.

Anlotinib hydrochlorides Capsules was previously approved for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer and differentiated thyroid cancer. Endometrial cancer ranks second among malignant tumors of the female reproductive system in China, and first in developed countries. With the increasing prevalence of high-fat and high-calorie dietary patterns and the gradual spread of unhealthy lifestyles, the incidence of endometrial cancer continues to rise, especially among younger women in China.

In 2016, the number of new cases of endometrial cancer reached 71,000 in China, with an incidence rate of 10.54 per 100,000 people. Currently, platinum-based chemotherapy is the first-line therapy for endometrial cancer in China. However, for patients with progress after first-line treatment, there is no standard clinical treatment protocol; patients have limited clinical treatment options and poor prognosis; thus, there is urgent need for effective treatment modalities.

Benmelstobart in addition, Benmelstobartin combination with AnlotinibHydchloride Capsules is currently undergoing a number of Phase III clinical trials, and is expected to be in the first PD-L1 inhibitor and small molecule anti-angiogenic drug combination therapy approved for recurrent or metastatic endomet trial in China, addressing the unmet clinical needs and benefiting patients in China. At the same time, it also signifies that Benmelstobart has successfully laid out another important area after small cell lung cancer. In addition, Ben Melstobart in combination with an important area after small cell lung Cancer.

In addition, Benmel Stobart in combination with An lotinib Hydrochloride Capsule is currently undergoing a number of phase III clinical trials, the Phase III clinical trials, and the Phase III clinical trials, the first PD-L1 study.