Yaoyuan Pharmaceutical's cGMP Dosage Form Platform Officially Operational, Bridging Clinical to Commercial Manufacturing Services

VCBeat (WeChat ID: vcbeat) has learned that on December 15, 2018, Pharmablock Laboratories (Shanghai), Inc. announced that its subsidiary, Pharmablock Biologics (Qidong) Co., Ltd., had officially commenced operations of its cGMP formulation pilot and manufacturing platform (hereinafter referred to as the “cGMP Formulation Platform”) in the Qidong High-Tech Industrial Development Zone, Jiangsu Province. This zone is a key area for pharmaceutical development in Jiangsu Province, located just a 1.5-hour drive from Zhangjiang, and is currently working to integrate with Zhangjiang Pharma Valley to establish a unified base.

Group photo of guests and DrugSource employees at the opening ceremony of the cGMP formulation platform. Photo provided by DrugSource Pharmaceuticals

The newly opened cGMP drug product facility spans 3,000 square meters and features three production lines: two for oral medications and one for topical medications. It is equipped with comprehensive supporting facilities, including warehousing, Quality Control (QC), Air Handling Units (AHU), purified water systems, and wastewater treatment. The platform accepts commissions for the production of clinical trial samples and contract manufacturing under the Marketing Authorization Holder (MAH) system, serving both domestic and international clients. Its production capacity reaches approximately 250,000 capsules/tablets per day for oral formulations and 20,000 tubes per day for topical formulations, with a minimum batch size at the kilogram scale, thereby meeting diverse market demands.

cGMP Formulation Platform Corridor. Image provided by PharmAblo.

Purified Water System of the cGMP Formulation Platform. Image provided by Pharmaron.

cGMP Formulation Platform: Fluidized Bed (Image provided by Pharmaron)

It is reported that the cGMP formulation platform commenced construction after the Spring Festival in 2018, with hardware infrastructure completed and equipment installed concurrently by October of the same year. Designed by a team from the Jiangsu Provincial Pharmaceutical Industry Design Institute, the platform adheres to cGMP requirements throughout all stages, from cleanroom design to construction, thereby supporting simultaneous regulatory filings in both China and the United States.

Dr. Wang Yuan stated that in recent years, with the continuous introduction of substantive policy incentives—such as encouragement for innovative drug development, consistency evaluation of generic drugs, and the Marketing Authorization Holder (MAH) pilot program—domestic drug research and development has become increasingly active. On the supply side, the production capacity of existing large-scale CDMOs is saturated, while the quality of smaller institutions varies significantly. This situation presents opportunities for Pharmablock to expand its new business lines. Consequently, establishing an independent cGMP formulation platform has become both an intrinsic driver for corporate enhancement and an urgent requirement for accelerating development.

The completion and commissioning of the cGMP formulation platform have enabled Yaoyuan Drug to further extend its business value chain, expanding its service scope from pharmaceutical research to the clinical sample production of innovative drugs and the commercialization of specialty products. The platform is also capable of accepting technology transfers from Marketing Authorization Holders (MAHs), thereby providing stronger support for the development of innovative and specialized drugs. Moving forward, Yaoyuan Drug’s business landscape will be driven by a dual-engine strategy: the API and formulation development platform in Zhangjiang, Shanghai, and the formulation pilot-scale and commercial production platform in Qidong, Jiangsu.

Dr. Wang Yuan told VCBeat that Pharmaron Qidong’s cGMP formulation platform has adopted a “small but specialized” strategy, deeply understanding and valuing the critical importance of innovative drugs to biotechnology companies. Typically, the R&D of innovative drugs at biotech firms demands stringent control over timelines, high work quality, and seamless cross-functional collaboration. In response, Pharmaron strives to precisely align with clients’ unique characteristics and the need for flexibility and frequent communication in specific therapeutic areas. By mobilizing its technical expertise and team resources to fully meet the differentiated needs of each client, Pharmaron has established a competitive advantage distinct from that of large CDMOs holding dominant market positions.

Yaoyuan Pharmaceutical adheres to standardized requirements in work quality and business management, striving for excellence. Meanwhile, Yaoyuan Pharmaceutical arranges for core management personnel to directly participate in projects, integrating resources from top to bottom to address issues arising during the R&D process from a holistic project perspective. The company provides full-process intellectual property protection for innovative drug data provided by clients, signs non-disclosure agreements, and implements encrypted management for internal documents and information systems.

Yaoyuan Pharmaceutical was established in 2003, specializing in pharmaceutical process R&D. With 15 years of experience in domestic and international drug development and services, the company provides drug manufacturing process development, regulatory filing assistance, GMP consulting services, and supports domestic pharmaceutical manufacturers in completing project technology transfer and production. Yaoyuan Pharmaceutical excels in synthesis and analytical technologies for various categories of small-molecule drugs, including chiral drug technology and research and testing technologies for genotoxic impurities. Its distinctive capabilities include solubilization technologies for poorly soluble drug formulations, topical formulations, and oral sustained- and controlled-release technologies. Furthermore, Yaoyuan is well-versed in European and American drug registration regulations and has accumulated extensive experience in preparing CMC documentation in both Chinese and English, enabling simultaneous support for domestic and international regulatory submissions.

Dr. Wang Yuan is an overseas talent who returned to China in 2003 to start a business. Before returning, Dr. Wang earned his Ph.D. in organic synthesis in France and completed his postdoctoral research in Canada. Subsequently, Dr. Wang joined a foreign pharmaceutical company, where he engaged in the research and development of drug manufacturing processes, accumulating extensive experience in process scale-up and Good Manufacturing Practice (GMP) certification for pharmaceutical facilities.

At the outset of his entrepreneurial venture upon returning to China, foreign pharmaceutical companies were increasingly active in outsourcing production operations in the country, while domestic pharmaceutical firms lacked expertise in standardized regulatory registrations for Europe and the United States. Dr. Wang Yuan decided to leverage his overseas experience by establishing operations in China, focusing Pharmaron’s business on pharmaceutical process development and regulatory submissions, and providing customized development and manufacturing services.

Over the past 15 years, PharmSource has successfully completed more than 20 cGMP on-site audits and third-party audits (e.g., by PAREXEL UK) for clients in Europe and the United States; it has helped pharmaceutical manufacturers smoothly pass official cGMP inspections by regulatory authorities such as the U.S. FDA, Health Canada, and the European Union, thereby facilitating their entry into international markets. In recent years, against the backdrop of the rapid alignment of China’s pharmaceutical regulations with international standards, PharmSource has rapidly expanded its presence in the domestic market, undertaking new drug development projects for multiple pharmaceutical companies and successfully passing numerous domestic R&D on-site inspections.

Currently, Yaoyuan’s R&D team comprises more than 80 members. Upon onboarding of a new project, Yaoyuan Pharma will first hold a project initiation meeting to designate the project leader and assign R&D personnel from various specialties, thereby establishing a relatively stable project team.

Based on the requirements and milestones of each project, corresponding synthetic chemistry, analytical, and formulation researchers are assigned to each project team. The teams operate with high efficiency and a fast pace throughout the service process, with regular internal communications on progress. Project teams maintain real-time interaction with clients in accordance with R&D progress. With the establishment of the cGMP formulation platform, Pharmablock’s R&D team will be further expanded.

After establishing a cGMP formulation platform and implementing a dual-drive strategy, Yaoyuan Drug aims to engage more actively in clinical medication and innovative drug manufacturing services. For distinctive generic drugs, Yaoyuan facilitates rapid development and market launch.