NO.1 and Huang Medicine's new lung cancer drug, Savotinib, have been approved for new indications

On January 13th, the official website of the National Medical Products Administration (NMPA) of China announced that the application for the new indication of Savotinib tablets by Hehuang Pharmaceutical has been approved. Sevotinib is a highly selective oral MET inhibitor. According to a previous press release from Hehuang Pharmaceutical, the drug has been approved for the treatment of locally advanced or metastatic non-small cell lung cancer in adult patients with mesenchymal epithelial transition factor (MET) exon 14 mutation.

Comment: Hehuang Pharmaceutical has made breakthroughs in the field of innovative drugs in recent years. At the beginning of the year, the company transferred the shares of its subsidiary company that operates traditional Chinese medicine products, further focusing on innovative medicine business.

Johnson&Johnson's new cancer drug, Edatinib, has been approved for marketing in China

Johnson&Johnson announced that its application for the marketing of Adatinib tablets has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who carry susceptible FGFR3 gene variants and have undergone at least first-line surgery containing anti-PD-1 or anti-PD-L1 during or after disease progression and cannot be removed. Public information shows that erdafitinib is a pan FGFR inhibitor.

Comment: Johnson&Johnson is still developing a novel drug delivery system for targeted release of edatinib in the bladder, which can sustain local release of edatinib at very low doses for a long period of time. This product has previously achieved positive results in the Phase 1 trial, and the complete remission (CR) rate of high-risk non muscle invasive bladder cancer is 90%. We look forward to the approval and launch of Erdaptinib in China, which will bring new treatment options to more cancer patients.

NO.3 Kangfang/Summit Ivoxidan Anti Activation 5 Head to Head Phase III Clinical Trials

According to the ClinicalTrials website, Summit Therapeutics, a partner of Kangfang Biotech, has registered a phase III clinical trial (NCT06767514, HARMONI-7) to compare the efficacy of first-line treatment with bevacizumab and pembrolizumab in patients with PD-L1 high expression (TPS ≥ 50%) metastatic NSCLC. According to the Insight database, this is the fifth head to head Phase III study initiated by Ivosi.

Comment: In the mid-term analysis of the Phase III clinical trial (HARMONI-2) for first-line treatment of PD-L1 positive (TPS ≥ 1%) NSCLC in September 2024, the data of Ivoxidan drug was superior to that of pembrolizumab monotherapy. In addition to head to head studies on the combination therapy of pembrolizumab, Iveiximab has also conducted head to head studies on trastuzumab and durvalumab.

NO.4 Lizhu Pharmaceutical terminates PD-1 development

Lizhu Pharmaceutical has announced that, taking into account factors such as domestic competitors and future market forecasts, and after careful consideration, in order to allocate resources reasonably and better focus on advantageous projects, it has decided to terminate the PD-1 project. There is currently only one PD-1 monoclonal antibody under development by Lizhu Pharmaceutical, namely Lipustobart (LZM009), which is currently in the stage of application for market launch.

Comment: There are 11 PD-1 monoclonal antibodies and 8 PD-L1 monoclonal antibodies that have been launched in China. From the perspective of competitive environment and market prospects, LIZHU Pharmaceutical's LIPusubimumab will face commercialization challenges even if it is launched.