Chinese Pharma Companies Accelerate Global Expansion as Innovative Drugs Gain FDA Recognition

　　【Pharmaceutical Network Industry Dynamics】Obtaining FDA approval for new drug clinical trials in the United States is an important step in the global layout of innovative drugs for many Chinese pharmaceutical companies. In recent years, with the continuous enhancement of R&D capabilities of China's innovative pharmaceutical enterprises, the number of innovative drugs passing FDA review and entering clinical trials or being marketed in the U.S. is gradually increasing.
 

On May 22, it was reported that Zenitar's innovative chemical drug Class 1, Furotinib Maleate Tablets, recently received clinical trial approval (IND) from the U.S. Food and Drug Administration (FDA), and is approved to conduct Phase I/II clinical trials in the United States for the treatment of myeloproliferative neoplasms (MPN).
 

According to reports, Furotinib Maleate Tablets are a novel triple-target inhibitor of JAK2/FLT3/CDK6 independently developed by Zenitar. Preclinical studies have shown that, compared with existing therapies, it has the advantages of higher selectivity and lower toxicity, and is expected to address clinical challenges such as splenomegaly and abnormal blood counts in patients with myelofibrosis.
 

Previously, the drug has been approved in China to conduct clinical trials for BCR-ABL fusion gene (Ph) negative MPN, covering three major hematological disease areas: Polycythemia Vera (PV), Essential Thrombocythemia (ET), and intermediate/high-risk Myelofibrosis (MF).
 

On May 21, GB18 Injection, an innovative drug developed by Shenzhen Kexing, a wholly-owned subsidiary of Kexing Biopharm, received clinical trial approval from the U.S. FDA for the treatment of cancer cachexia. GB18 Injection is an innovative drug targeting the GDF15 site, with clear differentiation advantages, and is expected to achieve a subcutaneous injection frequency of once every 3~42 weeks. In March 2025, the clinical trial application for this drug was accepted by the National Medical Products Administration of China.
 

This time, Kexing Biopharm's GB18 injection has received FDA clinical trial approval, marking an important breakthrough in the company's innovative drug research and development in the field of cancer cachexia, and will further assist in the globalization layout of its innovative drugs.
 

On May 20, Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., had received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets had been approved. The drug is mainly used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis, pulmonary embolism, and the prevention of venous thromboembolism in acutely ill patients. As of the announcement date, the company has invested approximately 8.2 million yuan in research and development costs. This approval will have a positive impact on the company's international development.
 

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For pharmaceutical companies, obtaining FDA approval not only reduces the costs of subsequent research and development and commercial promotion but also opens up fast-track approval channels in other countries. However, gaining FDA recognition is no easy task. Only products with differentiated safety and efficacy profiles, as well as drugs that can fill clinical treatment gaps, will truly be favored. Therefore, for pharmaceutical companies in China, only by continuously increasing R&D investment and strengthening their talent pool can they achieve continuous innovative breakthroughs in drug development and gain greater market competitiveness.
 

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