Among them, there is a PD-1 monoclonal antibody drug called Pembrolizumab Injection (trade name: Annike) independently developed by Kangfang Biotechnology from China in April 2025 ®) Approved by the US FDA for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) and at least two indications for platinum based first-line chemotherapy after progression.

 

According to the data, Pembrolizumab was independently developed by Kangfang Biotechnology and subsequently developed and commercialized by Kangfang Biotechnology and Zhengda Tianqing. This product is a PD-1 monoclonal antibody with IgG1 subtype and Fc segment modification. Its Fc segment modification avoids antibody dependent cell phagocytosis (ADCP) and cytokine release (ADCR) by eliminating binding to Fc γ R, reducing non-specific depletion of effector T cells, thereby enhancing anti-tumor activity and reducing systemic immune toxicity.

 

It is reported that nasopharyngeal carcinoma is a relatively rare tumor with significant regional distribution characteristics. Every year, there are over 133000 new cases of COVID-19 worldwide. The two indications of Pembrolizumab cover the treatment scenarios from the first-line to the back-end, providing patients with a comprehensive management plan and broad market prospects.

 

In addition to the aforementioned products, FDA approved products in the first half of the year also include Datroway (datopotamab deruxtecan) from AstraZeneca and Emrelis (telisotuzumab vedotin) from AbbVie, as well as Journavx (suzetrigine) from Vertex Pharmaceuticals, Blujepa (gepotidacin) from GSK, Qfitlia (fitusiran) from Sanofi and Alnylam, Imagination (nipocalimab) from Johnson&Johnson, and Avmapki Fakzynja Co pack (avutometinib+defactja) from Verastem Oncology. Innovative drugs such as inib, Tryptyr (acoltremon) from Alcon, and Andembry (garadacimab) from CSL Behring.

 

Among them, Datroway is an ADC drug produced by coupling humanized monoclonal antibody targeting TROP2 with innovative DNA topoisomerase I inhibitor (Dxd) through a cleavable tetrapeptide linker. The approved indication is HR positive and HER2 negative breast cancer.

 

Emrelis is composed of c-Met binding antibodies, cleavable linkers, and microtubule inhibitor MMAE payload, targeting tumor cells expressing c-Met with specific and high affinity binding. Its approved indication is non-small cell lung cancer with high c-Met expression.

 

Journavx is a new type of oral analgesic approved for decades, and also a highly anticipated non opioid analgesic. By selectively inhibiting NaV1.8 and intervening in pain signaling pathways, it can provide better analgesic effects while avoiding side effects such as addiction compared to traditional opioid drugs.

 

Blujepa is a novel triazepine oral antibiotic, indicated for simple urinary tract infections; Qfitlia targets SERPING1 gene mRNA, with indications for hemophilia A and B; Imaavy targets neonatal Fc receptor (FcRn) monoclonal antibody, with indications for myasthenia gravis; Avmapki Fakzynja Co pack is a combination therapy indicated for KRAS mutant ovarian cancer.

 

These 16 innovative drugs approved by the FDA in the first half of 2025 cover multiple therapeutic areas, from tumors to infections, from pain to immune diseases, and more. The approval of these innovative drugs, whether it is innovative achievements from China such as pembrolizumab or the research and development achievements of other international pharmaceutical companies, has brought more treatment options to patients worldwide and promoted the innovative development of the pharmaceutical industry.