Good News! Chengdu SBK Successfully Passes On-Site Inspection for Class B “Drug Manufacturing License” for Chemical Class 1 Novel Drug SBK002 Tablets

From March 24 to 25, 2023, a three-member expert team from the Evaluation Center of the Sichuan Medical Products Administration conducted a thorough on-site inspection at Chengdu SBK for the issuance of the Class B Drug Manufacturing License for our chemical Class 1 novel drug, SBK002 tablets.

During the inspection, company leadership provided a detailed presentation on SBK’s quality management system and its current R&D pipeline. The expert team reviewed a wide range of aspects, including the company’s organizational structure, personnel, quality management systems, quality control and assurance processes, risk management, contract production management, quality complaints and recalls, post-marketing studies, and pharmacovigilance systems, along with related documentation. This review was conducted in strict adherence to the Drug Administration Law, Provisions for the Supervision and Administration of Drug Manufacturing, Drug Inspection Management Measures (Trial), Good Manufacturing Practices (2010 Revision), and its appendices.

The results of the two-day inspection showed that there were zero critical deficiencies, zero major deficiencies, and four minor deficiencies. After a comprehensive discussion, the inspection team concluded that “the company’s proposed production scope (limited to registration and declaration purposes) complies with all relevant regulations for the issuance of a drug manufacturing license”. Finally, based on the company’s performance, the inspection team provided the following feedback: As an R&D-driven enterprise, Chengdu SBK is home to promising drug candidates and a dynamic, young team. However, the team shall continue to strengthen staff training to ensure comprehensive management, full participation across all levels, and effective oversight throughout the entire process.

Following the inspection, the company promptly gathered all relevant personnel for a debriefing and to discuss next steps. A corrective action report was drafted immediately to address the identified minor deficiencies. Additionally, all staff were encouraged to continue their study of the applicable regulations to ensure smooth progress toward obtaining the Class B Drug Manufacturing License from the Sichuan Medical Products Administration.

The successful completion of this on-site inspection represents a key milestone for Chengdu SBK, marking an important step forward in our journey toward product commercialization.