Year-End Work Summary

Chiheal (Shandong) Pharma has navigated a busy and fulfilling 2024. As we reflect on the year that is coming to a close, we acknowledge the correct guidance from the Group and the strong support and active collaboration from our sister units. Adhering to the work principle of "doing things thoroughly and practically" and the service motto of "high quality and cost-effective," we have worked diligently to improve our internal operations while striving to increase our market share.  

At the same time, we have strengthened internal management to enhance the company’s operational capabilities and overall competitiveness. Through the tireless efforts of all our employees, we have successfully completed several key projects. In the face of increasingly fierce market competition, the company’s leadership has been proactive, viewing challenges as opportunities, and has responded positively to ensure the establishment of a solid foundation for the company’s rapid development in the future.  

In order to learn from the past and continue to improve, we now present a summary of the work completed in 2024 and a forward-looking outlook for 2025

2024 Main Work Review

Quality Department

1. Completed the registration acceptance of 17 product varieties, conducted on-site production inspections for 8 projects, completed GMP combined inspections for 1 project, and carried out 2 additional inspections, including the addition of eye drop formulation for the 203B production line and the addition of small-volume parenteral (terminal sterilization) for the 201 production line, all of which passed smoothly.

2. Work completed to assist the marketing authorization holders:

   - Completed the filing of entrusted consent for 10 products.

   - Completed the production license change for 13 products to add the C certificate for entrusted production.

   - Completed the CDE registration for 5 BFS pharmaceutical packaging materials.

   - Conducted 17 on-site sampling inspections for registration by the Sixth Division of the Shandong Provincial Drug Administration (17 products).

3. B Certificate entrusted production status:

   - A total of 39 batches of production and release were completed throughout the year.

   - Achieved 100% pass rate in quality inspections with zero quality safety incidents for the year.

   - Conducted 2 audits of entrusted enterprise Haotong Pharmaceutical's system throughout the year.

4. Customer external audits and corrective actions:

   - Hosted 23 customer audits throughout the year and rectified identified defects.

5. Document management:

   - Added and updated over 1,000 documents in the document system this year.

   - A total of 35 deviations were handled as required.

   - Initiated 44 changes according to change control procedures.

6. Validation:

   - Conducted over 170 equipment validation/qualification activities throughout the year to ensure proper equipment operation.

   - Carried out computer system validation to ensure stable and reliable data.

7. Supplier management:

   - Conducted audits on suppliers in accordance with the supplier management procedures, including on-site audits or survey audits.

Production Department

1. Completed pilot batches and process validation batches for 7 product varieties throughout the year.  

2. Added and updated approximately 190 documents, process protocols, batch records, and upgraded files; completed 24 department training sessions.  

3. Built the production department system and conducted activities to improve the production line management level.

Equipment Department

This year, 63 documents and records were revised and updated, and 38 departmental training sessions were organized, with 270 participants.  

A total of 1,626 measuring instruments were calibrated, 161 preventive maintenance tasks for the plant were completed, 123 preventive maintenance tasks for equipment were finished, and 539 equipment failure repairs were carried out.

Sales Department

Market Access

National 8th batch annual re-registration and authorization of distribution units, signing of third-party contracts;  

Special adjustments for injectable drugs listed in the catalog, price governance and four-in-one linkage for provincial listings, drug traceability information collection, and submission of centralized procurement drugs for grassroots applications;  

Analysis of the 10th batch, Fujian Province Alliance volume-based procurement, Chongqing City's commonly used and shortage drug provincial alliances, Kunming City listing, and submission rule analysis for the 14 provinces of Shaanxi, including submission precautions and submission data review assistance;  

Establishment of distribution relationships in Jiangsu, Jiangxi, and Sichuan, with negotiation and confirmation.

First-time business exchange registration, product registration, or other documentation, brochures, etc., as well as the update of new qualifications for the year;  

After completing the shipment, submit the invoice application and issue the corresponding invoice to the commercial entity, with the contract included;  

Regular tracking of shipping progress, organizing logistics details, and settling shipping fees on a quarterly basis.

Marketing and Compliance

2025 Work Plan

Project Development

Based on the project approval progress and expected CMO outsourcing situation, it is anticipated that 20 projects will undergo process validation and commercial production in 2025. At the same time, there will be a strong focus on business development and sales.

Work Focus

Continuously optimize and improve systems and processes, and standardize the management of business flow, product flow, and cash flow.
Consistently enhance the company's accountability management and internal control levels, ensuring the efficient implementation of the company's control system. Effectively manage funds, implement the group's centralized procurement requirements, integrate business resources, and achieve diversified and sustainable development.

Focus on talent development and strengthen training efforts.

Focus on talent development and enhance team management capabilities. Gradually increase the talent pool, cultivate new types of versatile professionals, and strengthen the development of the talent hierarchy.
Increase training efforts to improve employees' professional knowledge and skills, fostering synergy with the company to reach higher goals and achieve long-term development.

Stabilize product quality.

Stabilize the quality of existing production products, always adhering to a quality-centric approach, continuously improving product quality control standards, and strictly implementing all quality management systems. Continue to achieve 100% pass rate in annual quality inspections and zero quality safety incidents throughout the year.
By thoroughly analyzing market demand and competitive trends, develop targeted product development strategies.

Focus on cost reduction and efficiency improvement.

The key focus for the second half of the year for the large pharmaceutical factory is to further increase revenue and reduce costs by identifying business pain points and lowering production costs. Focus on cost reduction and efficiency improvement to enhance the effectiveness of fund utilization.
Through strategies such as optimizing production processes, improving production efficiency, and making reasonable purchases, achieve cost savings while exploring ways to maintain higher profit margins in a competitive market.

The new year signifies a new beginning, with new opportunities and challenges. All employees of the large pharmaceutical factory will, under the correct leadership of the group, closely focus on the annual goals and tasks, work diligently to make progress, and move forward with determination. Together, we will fully embark on a new journey for the development of Chiheal (Shandong) Pharma!

About Chiheal (Shandong) Pharma

Chiheal (Shandong) Pharma Co., Ltd., established in October 2020, is a modern high-end formulation production base developed and built by Chihealbio It is a key investment project in the Luxi New District of Heze City, China, in 2020, and was included in the list of major projects by the Shandong Provincial People's Government in January 2023.

The company is a professional CDMO/CMO service provider for pharmaceutical formulation pilot/registration batch production/commercial production, with an integrated R&D and manufacturing model. Chiheal (Shandong) Pharma operates several drug formulation platforms, including vial lyophilization/water injection, oral solutions, BFS small volume injectables, BFS eye drops, BFS inhalation solutions, and BFS ear drops. The company holds pharmaceutical production licenses for A, B, and C certificates and has already commenced production on nearly 30 different products.