Recently, Chiatai Tianqing Pharmaceutical Group's randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE's consent to submit a marketing application for the addition of this new indication for bemosuzumab in combination with amiloride hydrochloride capsules. The Company will submit the marketing application in the near future.

Chiatai Tianqing has independently developed a new sequence of innovative humanized anti-PD-L1 monoclonal antibody, and in April 2022, bemosubimab in combination with amlotinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer was included in the breakthrough therapeutic categories by the CDE, and in January 2023, bemosubimab's application for marketing was formally accepted by the CDE for the first-line treatment of recurrent or metastatic endometrial cancer in combination with amlotinib hydrochloride capsules. In January 2024, bemosubaisumab in combination with amlotinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer was accepted by the CDE for Priority Review and Approval. in May 2024, bemosubaisumab in combination with amlotinib hydrochloride capsules and chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer was approved for marketing.

Anrotinib hydrochloride capsule is an oral novel small molecule multi-target tyrosine kinase inhibitor (TKI) independently developed by Chiatai Tianqing.In May 2018, Anrotinib hydrochloride capsule was approved for marketing by the State Drug Administration (SDA) and was the first drug approved in China for the third line of treatment of advanced stage non-small cell lung cancer.In February 2024, a marketing application for the seventh indication of Anrotinib was officially CDE accepted for the treatment of recurrent or metastatic endometrial cancer in combination with bemosuzumab. Up to now, Anrotinib hydrochloride capsules have been approved for six indications in China: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer, differentiated thyroid cancer and first-line small cell lung cancer.

Renal cancer is the third most common malignancy of the urinary system worldwide, and RCC accounts for 80-90% of all renal cancer cases. According to statistics, the number of new cases and deaths of renal cancer in China in 2022 will be about 77,000 and 46,000 cases, respectively. About one-third of renal cancer patients have already developed distant tumor metastasis at the time of initial diagnosis, while 20-50% of limited patients still develop distant tumor metastasis after undergoing nephrectomy. Based on the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium, the median overall survival (OS) of low-risk, intermediate-risk, and high-risk metastatic RCC patients treated with antivascular targeted therapies were 35.3, 16.6, and 5.4 months, respectively. In recent years, PD-(L)1 inhibitors combined with antivascular-targeted drugs have been successfully used overseas in the first-line treatment of advanced RCC, replacing antivascular-targeted drug monotherapy as the new standard first-line treatment option for advanced RCC. Compared with antivascular-targeted drug monotherapy, PD-(L)1 monoclonal antibody combined with antivascular-targeted drug therapy can significantly prolong patients' PFS, improve the objective remission rate (ORR), and a significant benefit in OS can be observed.

As the first pivotal phase III study of dual domestic innovative drug combinations for immunotherapy in advanced renal cancer, the ETER100 study (NCT04523272) is a randomized, open, positive drug-parallel-controlled, multicenter phase III clinical study designed to evaluate the efficacy and safety of bemosuzumab in combination with aniloticinib hydrochloride capsules versus sunitinib malate capsules in the first-line treatment of advanced unresectable or metastatic RCC with efficacy and safety. According to the results of the interim analysis of this study, the first-line treatment of advanced RCC with bemosubaisumab in combination with amlotinib significantly reduced the risk of disease progression or death in patients, while improving secondary endpoints such as ORR and OS. The safety data for bemosubicin monotherapy were consistent with known risks, and no new safety signals were identified. (Detailed research data from this study will be presented by the Company at an international academic conference in the near future.)

Behmosubaisumab combined with Anrotinib Hydrochloride Capsules will bring new therapeutic hope to the majority of patients with advanced kidney cancer, address the unmet clinical needs, and benefit domestic patients. At the same time, it also marks another important area where Behmosubaisumab continues to lay out its research after the field of small cell lung cancer and endometrial cancer. First-line advanced renal cell carcinoma will be the third indication declared for bemosubicinumab and the eighth indication declared for amrutinib hydrochloride. In addition, Behmosubaisumab combined with Anrotinib Hydrochloride Capsule is undergoing a number of clinical Phase III trials, including first-line non-small cell lung cancer and maintenance after radiotherapy for non-small cell lung cancer, etc. Chiatai Tianqing will continue to promote the development of Behmosubaisumab and Anrotinib Hydrochloride Capsule to bring new treatment options to more patients. With the company's continuous investment in innovative drug research and development, innovative products have achieved continuous breakthroughs, and the innovation pipeline has entered the harvest period.

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