Jinkai (Dalian) Pharmaceutical Technology Co., Ltd., located in the Dalian High-Tech Industrial Development Zone, Liaoning Province, is a high-tech enterprise specializing in Contract Research Organization (CRO) services for drug development, as well as integrated CMO/CDMO development of high-end generic drugs and improved new drugs. The company has a registered capital of RMB 50 million, fully paid-in. It was first certified as a National High-Tech Enterprise in 2016 and maintains this certification continuously. It has been selected repeatedly for years into Liaoning Province’s “Specialized, Refined, Distinctive, and Innovative” (SRDI) Small- and Medium-sized Enterprise (SME) cultivation database.  

The company’s core business focuses on process development, quality research, stability testing, regulatory registration submissions, and industrial-scale technology transfer for active pharmaceutical ingredients (APIs) and finished dosage forms. Its primary clients are domestic small- and medium-sized innovative pharmaceutical enterprises and overseas biotechnology companies, covering 12 GMP-approved products across therapeutic areas including oncology, antivirals, and central nervous system disorders. Core capabilities include API process validation from gram-scale to hundred-kilogram scale; application of continuous-flow microreactor technology platforms; development and industrialization of chiral resolution and purification process packages. Notably, it has achieved an 82.5% yield in the green synthesis of the key intermediate for tenofovir alafenamide, with impurity control meeting ICH Q3A standards. The company operates a 2,200 m² GMP pilot plant and a CNAS-accredited analytical testing center (L12389), and possesses FDA Drug Master File (DMF) registration capability (three DMFs, numbers 29562, 31087, and 33421) and European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificate of a Suitability (CEP) (R0-CEP 2024-0176).  

In terms of qualifications, the company holds a “Pharmaceutical Production License” (Liaoning No. 20220003), ISO 9001:2015 and ISO 14001:2015 certifications, and passed a U.S. FDA on-site inspection in October 2024 (Report No. FDA-INS-2024-1187) with zero Form 483 observations. Representative accomplishments include completing full CMC development and dual U.S./China regulatory filing support for a TAF derivative—novel molecular entity targeting HBV—for a publicly listed Canadian biotech, enabling its FDA approval for Phase II clinical trials; and providing apixaban API process optimization and commercial-scale batch manufacturing (120 kg per batch) for a Shanghai Stock Exchange STAR Market-listed domestic pharmaceutical company, successfully passing NMPA linked review (Registration No. Y20230012345). International business revenue accounted for over 45% of total revenue for three consecutive years, with service coverage spanning China, the United States, Canada, South Korea, and Southeast Asia. Contracts are executed in English and governed by English law. Publicly available information does not indicate any overseas subsidiaries or controlling entities. Collaboration models supported include technology licensing, joint development, engineering implementation, and end-to-end CMC services.