China's Anti-Cancer Drug Sector Enters a Harvest Period with Multiple Breakthrough Therapies Approved for Clinical Trials

　　【Pharmaceutical Network Market AnalysisRecently, the national launch conference of Cadonilimab Injection (brand name: Kaitanini®), the world's first bispecific antibody drug targeting dual immune checkpoint inhibitors independently developed by Akeso Biopharma, was held in Huangpu District, Guangzhou City. This new drug, independently developed by Akeso Biopharma, has been approved for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy. The drug is China’s first bispecific antibody for tumor immunotherapy and the first approved tumor immunotherapy drug for the treatment of cervical cancer.
 

Clinical research data show that, compared with the therapies already approved in China, the median overall survival of Cadonilimab in all-comer patients with recurrent or metastatic cervical cancer reached 17.51 months, extending the overall survival by 8 to 13 months over the approved therapies. In addition to its use in cervical cancer treatment, Cadonilimab is also being rapidly advanced in research for gastric cancer, liver cancer, non-small cell lung cancer, and nasopharyngeal carcinoma.
 

Coincidentally, on July 4, Hansoh Pharma also announced that "Palbociclib Capsules," developed by its subsidiary Jiangsu Hansoh Pharmaceutical Group Co., Ltd., had received a drug registration certificate from the National Medical Products Administration of China. The product is an anti-tumor drug, suitable for locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative, and should be used in combination with aromatase inhibitors as the initial endocrine therapy for postmenopausal female patients.
 

In fact, in recent years, with the continuous growth of the oncology drug market size, pharmaceutical companies in China are actively competing to establish a presence in this field. Currently, in addition to the successive launch of new drugs, the clinical development of innovative oncology drugs in China is rapidly advancing, driven by policies encouraging innovation and the impact of centralized procurement measures. Since July, several anti-tumor drugs have received clinical trial approvals.
 

On July 12, Zhejiang Medicine announced that its subsidiary, Zhejiang Newcode Biopharmaceutical Co., Ltd. ("Newcode Bio"), received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for the injection of recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate (ARX305), approving the conduct of clinical trials of this drug as a monotherapy in patients with advanced tumors.
 

ARX305, the injectable recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate, is a next-generation monoclonal antibody conjugate drug co-developed by Novel Biomedicine and U.S.-based Ambrx Inc. under a "Co-development and License Agreement" signed on October 22, 2019, for the treatment of advanced tumors expressing CD70.
 

On July 11, Hengrui Medicine announced two drug clinical trial approvals: the Phase Ib/II open, multi-center clinical study of SHR-1701 injection combined with Almonertinib and other innovative drugs for the treatment of EGFR-mutated recurrent or advanced non-small cell lung cancer, and the clinical trial of HRS-1167 tablets for advanced solid tumors.
 

On July 5, Fosun Pharma announced that its holding subsidiary, Shanghai Fosun, received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for FS-1502 (i.e., Recombinant Humanized HER2 Monoclonal Antibody-Monomethyl Auristatin F Conjugate for Injection) in combination with serplulimab and/or chemotherapy for the treatment of patients with HER2-expressing advanced gastric cancer…
 

Industry analysis believes that the field of anti-tumor drugs, as a popular disease area, will gradually enter the harvest period with the continuous efforts of pharmaceutical companies. However, it should be noted that with the normalization of drug procurement and medical insurance negotiations, the exclusive market rights for anti-tumor drugs will become shorter. Even exclusive new drugs will find it hard to maintain a long-term position, so competition among enterprises in this field will become increasingly fierce in the future.
 

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