Product Quality and Safety
Product quality is the foundation of Joincare’s steady growth. We are committed to delivering high-quality products and services to our customers by continuously enhancing our comprehensive quality management system throughout the product lifecycle—from R&D and development to post-market patient use. We strengthen supply chain management to ensure the quality of raw materials, and adhere to responsible marketing principles to promote our products with accuracy and integrity, safeguarding public health with unwavering dedication.
Quality Management System
We have established and continuously refined a full-lifecycle quality management system that covers drug development, manufacturing, marketing, and use. In proactive response to regulatory requirements, we diligently fulfill our responsibilities as the marketing authorization holder, striving to provide patients with high-quality and reliable products.
Certification of the Quality Management System
Certification
7 companies have passed GB/T 19001-2016/ISO 9001:2015
1 company passed ISO 22000:2018
2 companies have passed ISO 13485:2016
1 company passed ISO/IEC 17025:2017
1 company passed CNAS-CL01
Quality Training for Employees
Joincare places great importance on product quality training and advocacy, establishing employee quality training management procedures based on standards such as GMP, GSP, GVP, and CNAS, and formulating annual quality training plans covering all employees. The Human Resources Department is responsible for organizing and supervising employee education and training, and establishing health files. The Quality Management Department is responsible for maintaining the roster of quality-related personnel, dynamically updating personnel information, tracking the implementation of training plans, and establishing training archives. The Group incorporates the implementation of annual training and the completion of training for key position personnel into quality management work reports, ensuring continuous improvement and effective traceability. In addition, the Group improves employees' product quality management capabilities and awareness through diverse training formats such as quality micro-courses, fun sports competitions, online knowledge competitions, and operational skills competitions.
The Group actively participated in multiple external professional training sessions organized by drug regulatory authorities and certification bodies, covering areas such as GSP implementation, MAH contract manufacturing supervision, qualified person performance of duties, internal auditor qualifications, and improvement of enterprise management representative capabilities, simultaneously strengthening quality, environmental, and occupational health and safety management system capability building, and genuinely fulfilling the enterprise's primary quality responsibility.
In 2025, Joincare continuously conducted product quality and safety-related training sessions, with employee coverage reaching 100%.
Product Quality and Safety Objectives
Joincare is committed to the continuous improvement of its quality management system, the refinement of operational mechanisms, and the enhancement of quality monitoring capabilities. We have established overall corporate quality objectives and conduct ongoing annual reviews of their achievement. Key targets include:
100
%
Pass rate in market sampling
<1
%
Customer complaint rate
>90
%
Customer satisfaction rate
100
%
Individual case adverse reaction report submission compliance rate
100
%
Safety summary report submission compliance rate
Supply Chain Management
Joincare actively collaborates with suppliers to build harmonious and mutually beneficial partnerships, ensuring supply chain stability and sustainable development.
Supplier Classification and Risk Management
During the supplier evaluation and management process, we prioritize comprehensive identification, assessment, and control of supply chain risks. Evaluation dimensions include Environmental, Social, and Governance (ESG) impacts as well as business relevance. For ESG-related risks, we conduct assessments across three levels—country risk, sector-specific risk, and product-specific risk—to identify our key suppliers and critical indirect suppliers.
Dimension of supply chain risk assessment
Supply Chain Risk Mitigation Plan
To ensure production stability and product quality and safety, we have developed comprehensive and systematic risk mitigation strategies and contingency plans tailored to our supply chain and business operations. In the procurement stage, we have established and continuously improved a dual-sourcing system and implemented policies for alternative suppliers. For raw materials, excipients, and key consumables, we maintain backup supplier options to mitigate the risk of supply disruptions. In the manufacturing stage, we integrate formulation development with the establishment of API production bases, actively advancing API manufacturing processes to enhance in-house production capabilities—aiming to achieve integrated “API + formulation” manufacturing. In addition, our multiple production facilities across China serve as mutual backup sites, enabling production support in the event of emergencies. We closely monitor the inventory levels of production materials and have implemented a series of risk response measures to safeguard production stability at the source. Subsidiaries also proactively adopt measures to address supply chain stability risks.
Supplier Audit and Evaluation
Referencing the responsible supply chain management principles of the Pharmaceutical Supply Chain Initiative (PSCI Principles) and industry practices, Joincare has formulated and implemented systems including the On-site Audit Management Procedure, Supplier Quality Review Management, Material Supplier Quality Audit Procedure, and Supplier Management Procedure. In accordance with requirements, we regularly conduct on-site reviews and desk assessments of suppliers' qualifications, production premises, process technology and production facilities, warehousing management, quality management systems, environmental protection, and occupational health and safety management, and clearly set out work requirements for the Group's supplier auditors to continuously improve the standardization level of supplier management. In addition, where necessary, we engage third-party professional organizations to conduct on-site audits of suppliers. We continuously strengthen management of key indirect suppliers by conducting on-site audits of the manufacturers of key products procured from distributors (i.e., the Group's significant indirect suppliers), comprehensively inspecting production equipment and quality management conditions upstream in the supply chain to ensure that all capabilities of significant indirect suppliers meet our requirements.
Supplier ESG Management
Joincare systematically implements ESG management for suppliers, with continuous attention to their sustainability practices and performance. The Group’s Sustainability Committee under the Board of Directors serves as the highest decision-making body, responsible for overseeing the implementation of supplier ESG management.
We have clearly defined ESG expectations for suppliers in the Supplier Code of Conduct, and we emphasize ESG performance throughout key processes such as onboarding, audits, and evaluations.
Case: Joincare’s subsidiaries conducted supplier training
In 2025, Joincare Haibin conducted quality improvement training for high-risk material suppliers, communicating the Group's quality management objectives to suppliers and strengthening their understanding of key quality management and EHS management points.
In 2025, Haibin Pharma conducted a total of 13 supplier quality training sessions, communicating the Group's quality management requirements to suppliers and strengthening quality management awareness to ensure that products are sourced safely and reliably. In addition, Haibin Pharma supports suppliers in enhancing their sustainable development capabilities through approaches such as dispatching personnel to conduct on-site coaching, for example conducting on-site coaching for the anhydrous sodium carbonate (sterile grade) supplier on aseptic operating standards and following up on rectification and implementation.
In 2025, Jiaozuo Joincare conducted a series of systematic and targeted quality training activities for raw material suppliers, with training content centered on three themes: "New Employee Induction Quality Awareness Training", "5S Management Training", and "Supplier Management Training", primarily covering Class A significant material and Class B general material suppliers. Through case sharing, interactive sessions, and hands-on guidance, the training helped suppliers gain a deep
understanding of the importance of quality awareness, master 5S site management methods, and clarify their responsibilities and requirements within the supply chain. Through two-way communication and experience sharing, the initiative not only enhanced suppliers' quality and EHS management capabilities but also strengthened the collaborative partnership between us and our suppliers.