Core Insights - The article discusses the recent clinical trial applications submitted by several pharmaceutical companies, focusing on the competitive landscape of PD-1 inhibitors in the oncology market [12][11]. Group 1: New Drug Applications - From June 13 to June 18, the National Medical Products Administration received applications for 9 new chemical and biological drugs from 6 listed companies [4]. - Companies such as Hengrui Medicine, Innovent Biologics, and CSPC Pharmaceutical Group submitted 2 clinical applications each, while companies like Ascletis Pharma, Junshi Biosciences, and Kintor Pharmaceutical submitted 1 application each [7]. Group 2: Focus on Oncology Drugs - All applications during this period were for anti-tumor drugs, indicating a strong focus on oncology within the pharmaceutical industry [8]. - The article highlights that the PD-1 inhibitors submitted by Shijiazhuang Yiling Pharmaceutical and Junshi Biosciences are still in clinical trials, with no products yet on the market [12]. Group 3: Competitive Landscape - Currently, there are 8 PD-1/PD-L1 products approved in China, leading to intense competition among companies [12]. - Shijiazhuang Yiling's PD-1 is in Phase I clinical trials for ovarian cancer and Phase II for advanced/metastatic cervical cancer, while Junshi's PD-1 is at the application stage for MSI-H solid tumors [12][13]. - The article suggests that both companies need to adopt differentiated development strategies to avoid excessive competition and achieve market success [12]. Group 4: Market Positioning - Junshi's PD-1, known as Surulitinib, is positioned to be the first anti-PD-1 monoclonal antibody for treating MSI-H solid tumors in China, despite its later market entry [12]. - In contrast, Shijiazhuang Yiling's prospects for its PD-1 product appear less optimistic, as there are no approved PD-1 products for cervical cancer in the domestic market [13]. Group 5: Historical Context - Shijiazhuang Yiling previously had a partnership with Junshi Biologics for a PD-1 product but terminated the agreement to avoid potential conflicts with another in-house PD-1 candidate [14]. - This decision has led to a delay in Shijiazhuang Yiling's PD-1 development, while Junshi's product has been on the market for over two years, generating significant revenue [14].
掘金创新药丨PD-1竞争还在加剧，石药集团、复宏汉霖孰能突围宫颈癌适应症