Chinese Pharma's 2024 FDA Breakthroughs: Over 10 Companies Secure Key Milestones for Oncology and Beyond

　　【Pharmaceutical Network Industry DynamicsIn 2024, the trend of China's pharmaceutical industry expanding overseas remains strong. According to industry statistics, at least 10 Chinese pharmaceutical companies have made new progress with the U.S. FDA, including approvals for clinical trials, obtaining Fast Track designations, and receiving marketing approvals.
 

Only in March, there have been new developments in the U.S. listing of multiple domestically produced drugs. On the evening of March 12, Betta Pharmaceuticals announced that its controlling subsidiary, Xcovery, received a letter from the U.S. FDA. The FDA has completed the review of the submission documents related to the marketing authorization application for Ensartinib Hydrochloride Capsules (trade name: Beinina®, hereinafter referred to as "Ensartinib") intended for "the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for anaplastic lymphoma kinase (ALK)" (i.e., first-line indication). The FDA confirmed that the application materials are complete and can proceed to substantive review. Ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor, independently developed by Betta Pharmaceuticals and Xcovery.
 

Kelun Pharmaceuticals announced on the evening of March 11 that A400 (a Rearranged during Transfection (RET) small molecule kinase inhibitor project, also known as KL590586 or EP0031), a key product of its holding subsidiary Kelun-Biotech, has been granted Fast Track designation by the U.S. FDA for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC). Currently, Kelun-Biotech is conducting pivotal clinical trials in China for A400 (EP0031) targeting RET-positive non-small cell lung cancer.
 

On March 10, Poly Pharm announced that the benzylsuccinyl atracurium injection has received the FDA's approval for market in the United States. It is indicated as an adjunct to general anesthesia for tracheal intubation in adult and pediatric patients aged 1 month to 12 years; for maintaining skeletal muscle relaxation during surgery in adult and pediatric patients aged 2 to 12 years via bolus or infusion administration; and for mechanical ventilation in adult ICUs.
 

On the same day, December 10, BeOne Medicines announced that Brukinsa® (zanubrutinib) was granted accelerated approval by the U.S. FDA for use in combination with the anti-CD20 monoclonal antibody obinutuzumab to treat adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. The accelerated approval for this indication is based on the overall response rate and duration of response. This approval also marks the fifth B-cell malignancy indication for Brukinsa® in the United States. Notably, in 2023, BeOne Medicines' BTK inhibitor zanubrutinib (brand name "Brukinsa") achieved global sales of $1.3 billion, surpassing the $1 billion milestone.
 

Grand Pharmaceutical Group Limited recently announced that its ophthalmology partner, Formosa Pharmaceuticals, has received approval from the U.S. FDA for the New Drug Application (NDA) of GPN00833 (APP13007), a hormone nanosuspension eye drop used for post-operative anti-inflammatory and analgesic treatment in ophthalmology. Grand Pharmaceutical Group Limited holds the development and commercialization rights for this product in mainland China, Hong Kong, and Macao. This significant overseas progress of the product will further support its registration work in China.
 

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Since 2024, anti-tumor drugs remain the focus of attention in the industry among Chinese-produced drugs navigating FDA approval. This year, significant progress has been made in the U.S. for several oncology drugs, including A400, the main product of Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical; Docetaxel Injection from Huiyu Pharma; HER3 ADC innovative drug SHR-A2009 injection from Hengrui Medicine; a Nectin-4-targeted ADC innovative drug independently developed by Mabwell; and SIM0500, an anti-tumor new drug self-developed by Simcere Pharmaceutical.
 

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