As winter plum blossoms bloom and the twelfth lunar month welcomes spring, Chiheal Group held its senior management business conference on January 24, 2025. The meeting was attended by Dr. Zhang Zhefeng, Chairman of the Group, Ms. Hou Wen, Vice Chairman, and senior executives from various subsidiaries.

This conference aimed to review and summarize the work of 2024 while also looking ahead to and planning the key tasks for 2025. It focused on discussing work plans, strategies, and measures to achieve the annual goals for 2025, striving toward the set objectives with determination and effort.

Chiheal Aikang Pharma

Over the past year, Beijing Chiheal Aikang Pharma, as the core force of the registration and clinical business segment of Chiheal Group, has achieved remarkable results.

In the registration business, we successfully completed the post-marketing change registration for two imported drugs and obtained approval documents. Additionally, we completed multiple Pre-IND, IND, and NDA submissions for pipeline products on schedule, which have now entered the CDE review process.

The Clinical Medicine Department also delivered outstanding performance, completing clinical documentation, communication, and medical consulting services for over ten pipeline projects. Several clinical trial projects successfully reached key research milestones, with results meeting trial expectations, providing strong support for our clients in accelerating their regulatory submissions.

Furthermore, we successfully obtained certifications and honors such as Beijing High-Tech Enterprise Recognition, Technology-Based Small and Medium-Sized Enterprise (SME), Innovative SME, and the Beijing Science and Technology Program Expansion Award. These recognitions not only affirm our technical capabilities but also highlight our commitment to innovation.

Chiheal（Shandong）Pharma

Ruzhi Biomed

In 2024, Ruzhi Biomed focused primarily on its role as a Marketing Authorization Holder (MAH). Throughout the year, the company successfully expanded its B-license coverage to include 21 additional products. It passed GMP compliance inspections and obtained inspection notification letters for Penicillin Sodium for Injection, Lornoxicam for Injection, and Cefotaxime Sodium for Injection, covering three products and four registration numbers. Additionally, the company successfully underwent over ten inspections by provincial and municipal regulatory authorities.

Ruzhi Biomed also initiated production scheduling for three marketed products, supplying approximately 300,000 units of Lornoxicam for Injection across six batches, ensuring a 100% market supply rate. Drug vigilance efforts were carried out in an orderly manner, alongside several R&D projects. The company assisted Southwest Pharmaceuticals in obtaining the production approval for Oxacillin Sodium for Injection, submitted registration applications for five projects, and conducted supplementary research on two projects.

Thanks to these efforts, Ruzhi Biomed was successfully recognized as a Technology-Based Small and Medium-Sized Enterprise and a National High-Tech Enterprise in 2024. Looking ahead to 2025, the company will continue to push forward, overcoming challenges, strengthening its MAH operations, ensuring an effective and efficient quality system, and maintaining stable market supply.

Discovery Pharma conducted a comprehensive review of the outstanding achievements made by various departments in 2024.

In terms of corporate management, the company refined its daily operations, safety, environmental protection, and occupational health regulations while establishing the Government Affairs Department and Project Management Department. In 2024, the company was recognized as an "Innovative SME" and designated as a Hebei Province Biopharmaceutical Contract R&D Service Platform, while also obtaining ISO 9001 quality system certification.

On the project front, the Chemical Drug Team in Shijiazhuang completed 11 project registrations, with 2 currently under submission, 7 process validations finalized, and 5 projects under research. Additionally, the company successfully underwent multiple audits by various governmental authorities and completed four B-license expansion inspections.

Thanks to the joint efforts of the Group and all employees, Discovery Pharma successfully met its annual targets, making a significant contribution to the rapid development of the Group.

Rukang Biomed

As Chiheal Group’s MAH platform enterprise in the Hainan Free Trade Port, Rukang Biomed achieved significant milestones under the Group’s leadership in 2024. In July, the company successfully obtained its manufacturing license.

Over the year, 12 projects were initiated, with 4 projects completing MAH transfer applications, 2 projects completing registration acceptance, and 2 projects finalizing process validation and awaiting regulatory submission. Additionally, 5 projects underwent manufacturing license expansion and amendments.

Thanks to the dedication of all employees and the strong collaboration with the Group’s R&D team, Rukang Biomed successfully met its annual objectives.

In 2024, Chihealbio actively advanced its business development, closely collaborating with subsidiaries such as Beijing Aikang to jointly carry out clinical trials, registration submissions, and other projects. Significant progress was made with projects like Benalafon and Azithromycin for Children, while the long-term strategic focus on innovative and modified drugs gradually began to yield results. The international expansion of innovative drugs emerged as a new growth driver for profitability.

In 2025, Chihealbio will continue to increase investment in the fields of innovative and modified drugs, driving more projects into the clinical phase. The company will focus on advancing the already-launched innovative drug projects, aiming for more clinical approvals and registration progress. Additionally, by leveraging subsidiaries such as Beijing Aikang, the company plans to further expand clinical services and CRO (Contract Research Organization) business, strengthen collaborations with external companies, secure more clinical contracts, and enhance the overall business scale of the Group.

The company will optimize contract management by clarifying contract terms, improving project execution efficiency, and establishing more effective communication mechanisms to address any cooperation issues in a timely manner. Moreover, Chihealbio will proactively respond to the impact of national procurement policies, optimize its product pipeline, explore new profit models such as international expansion of innovative drugs, and reduce reliance on the domestic procurement market. The company will also focus on market research and analysis to explore non-procurement and international markets, searching for new business growth opportunities. Simultaneously, Chihealbio will strengthen team development and talent training, optimize personnel structure, and enhance team professionalism to provide strong support for the company’s growth.