Previous
JeYou Pharma's AR-NTD Inhibitor Clinical Trial Application Approved
September 28, 2026 — Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that its small molecule innovative drug manufacturing base, Zhejiang Hangyu Pharmaceutical Co., Ltd. (hereinafter "Hangyu Pharmaceutical"), has successfully obtained the Drug Production License (Type A Certificate) and the GMP Compliance Inspection Announcement. The acquisition of this qualification not only demonstrates that the company's small molecule production base is ready for commercial manufacturing, but also marks a new milestone for JeYou Pharmaceutical in achieving end-to-end capabilities—from development to commercial production—in the small molecule innovative drug sector.

Founded in 2021, Hangyu Pharmaceutical is located in the Qiantang Linjiang area of Hangzhou, Zhejiang Province, covering approximately 100 mu (about 6.7 hectares). The facility primarily engages in the production of Class 1 small molecule innovative drug formulations. Integrating globally advanced pharmaceutical technologies and equipment, the base possesses comprehensive capabilities spanning early-stage clinical sample production, pivotal clinical sample manufacturing, commercial production, and sales. It also provides high-quality CDMO/CMO services for innovative drug formulations to industry clients. Currently, the facility has an annual production capacity of 200 million tablets/capsules of solid dosage forms.
JeYou Pharmaceutical's small molecule innovative drug development matrix has already begun delivering innovative results to the market, exemplified by the Class 1 anti-tumor innovative drug Jielemei® (suximerex sulfate tablets), which was approved for marketing in February this year. This product is the first independently developed Class 1 innovative drug approved from JeYou Pharmaceutical's R&D platform and was previously granted Breakthrough Therapy Designation by the NMPA. The Hangyu Pharmaceutical team was fully involved in the product's technology transfer and scale-up production, continuously optimizing manufacturing processes to ensure high drug quality and safety while further enhancing the product's pharmacoeconomic advantages, ultimately benefiting clinical patients.
From R&D exploration to industrial implementation, JeYou Pharmaceutical has always adhered to a clinical-needs-first approach, delivering high-quality innovative drug products to benefit patients. The obtaining of the Drug Production License (Type A Certificate) and GMP Compliance Inspection Announcement once again validates JeYou Pharmaceutical's capabilities in the commercialization of small molecule innovative drugs, which will comprehensively empower the company's future multi-pipeline strategy and CDMO business expansion. JeYou Pharmaceutical will continue to leverage its integrated R&D, production, and sales platform to vigorously advance the development of innovative drugs in critical disease areas, while collaborating with industry partners to accelerate the commercial production and launch of innovative drug products, contributing to the high-quality development of the pharmaceutical industry.
About JeYou Pharmaceutical
Shanghai JeYou Pharmaceutical Technology Co., Ltd. focuses on the "3+1" core therapeutic areas of oncology, nephrology, pain, and autoimmune diseases, specializing in the R&D, manufacturing, and commercial translation of innovative drugs. The company has built a differentiated product portfolio with international competitiveness, covering monoclonal/bispecific antibodies, TCE, ADCs, small molecule drugs, and PROTACs, among other modalities. Its current self-developed product portfolio comprises 40+ candidates, with over 10 in clinical stages. In February 2026, the company's self-developed Class 1 anti-tumor innovative drug Jielemei® (suximerex sulfate tablets) was approved for marketing by the National Medical Products Administration.
Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that the clinical trial application for its self-developed AR-NTD inhibitor, the JMN-2205 tablet project, has been approved...
2026/10/10
Today, Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that the phase III clinical enrollment of the company's independently developed anti-IgE drug, oripazumab (JYB1904), for chronic spontaneous urticaria (CSU) has been completed three months ahead of schedule ...
2026/18/09
Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that the company's preclinical CDK4 inhibitor (JYC010145) and CDK2-PROTAC (JMKX009137) candidate drug molecules have initiated a new drug clinical trial application……
2026/11/08