China's Innovative Drug Approvals Reach 142 as Domestic Pharma Gains Global Momentum

　　【Pharmaceutical Network Industry DynamicsIn recent years, driven by both policy and market forces, the pharmaceutical industry in China has shown positive development trends. In particular, with the acceleration of review and approval processes, policy incentives, and strong capital support, investment in R&D for innovative drugs in China has continued to increase, leading to a steady stream of innovative achievements.
 

According to data statistics, as of now, the National Medical Products Administration (NMPA) has cumulatively approved 142 innovative drugs, with 1,112 varieties passing or deemed to have passed the consistency evaluation. A large number of innovative drugs, biologics, key vaccines, and traditional Chinese medicine compound preparations have been approved for marketing.
 

Recently, Zhejiang Jingxin Pharmaceutical Co., Ltd.'s Class 1 innovative drug, Didazinib Capsules, has been approved for marketing in China, becoming the first new drug in 16 years to improve sleep. It is reported that Didazinib belongs to the benzodiazepine class of drugs and is a partial positive allosteric modulator of the γ-aminobutyric acid type A (GABAA) receptor. By partially activating the GABAA receptor, it promotes sleep.
 

Beijing Purun'ao Biotechnology Co., Ltd.'s Class 1 innovative drug, Berotinib Enteric-Coated Capsules, has also recently been approved for marketing. This medicine is suitable for treating patients with locally advanced or metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations. Data shows that Berotinib is a cell-mesenchymal-epithelial transition factor (c-MET) receptor tyrosine kinase inhibitor that can inhibit the proliferation of tumor cells with high c-MET expression.
 

Juventas' Naciorlen Injection (Trade Name: Yuanruida) has also been recently approved for marketing. This drug is used to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. According to available information, Naciorlen Injection is an autologous T-cell immunotherapy product prepared using gene modification technology to express chimeric antigen receptors (CAR) targeting CD19 on the surface of T cells.
 

Wuhan Hiteck Biological Pharma Co.,ltd.'s Eprenetapoptin for Injection (trade name: Shaite) has also been recently approved for marketing. This drug, in combination with thalidomide and dexamethasone, is indicated for adult patients with relapsed or refractory multiple myeloma who have previously received at least two systemic treatment regimens.
 

In addition, the international strategic layout of China's pharmaceuticals industry is also accelerating. Data shows that from January to October this year, the total import and export value of pharmaceutical materials and medicines in China reached 439.8 billion yuan, and it is expected to reach 520 billion yuan for the whole year. And in traditional...Active Pharmaceutical IngredientsAgainst the backdrop of generic drugs going global, the pace of overseas expansion for vaccines and biologic innovative drugs is also accelerating.
 

Recently, Ryzneuta®, a biologic innovation drug independently developed by Yifan Pharmaceutical Co., Ltd., has been approved for marketing in the United States. This marks the first case where a Chinese pharmaceutical company successfully submitted a complete BLA (Biologics License Application) to the FDA (U.S. Food and Drug Administration) with its own team and officially received approval. Data shows that Ryzneuta® is a large-molecule biologic innovation drug that Yifan Pharmaceutical developed over more than a decade using its own research team. Currently, the drug is mainly used to treat neutropenia in cancer patients who develop the condition after receiving anti-cancer drugs. It enables the rapid proliferation and recovery of neutrophils, thereby enhancing the immune system's ability to resist infections.
 

Fruquintinib, co-developed by Hutchmed and Takeda, has recently been successfully launched in the United States. The drug is used to treat specific types of colorectal cancer and is a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis.
 

Numerous Chinese pharmaceutical companies have actively expanded into international markets, accelerating the implementation of their globalization strategies and driving the robust growth of pharmaceutical foreign trade. Industry experts indicate that, overall, driven by both policy support and market demand, the development of China's pharmaceutical supply chain shows positive trends. Currently, China's pharmaceutical distribution sector is maintaining a recovery growth rate, with the overall pharmaceutical industry market size remaining stable and the supply chain resilience further strengthened. Data shows that in the first three quarters, the total sales of pharmaceuticals in China amounted to approximately 2 trillion yuan, with an estimated total of 2.89 trillion yuan for the entire year of 2023, representing a year-on-year increase of about 5%.
 

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