Yifan Pharmaceutical Co., Ltd.
亿帆医药
002019
Shenzhen Stock Exchange
Company Profile
1、Biologics (Biopharmaceuticals) Field The company has been deeply cultivating the field of biologics for many years, especially relying on the international development journey of the Ryzneuta product in China and globally, and has established a full life-cycle undertaking system covering new drug discovery, CMC research, clinical development, and commercial production. This system covers key global new drug markets including China, the United States, and Europe. At the same time, relying on a cross-regional collaborative network, we efficiently integrate global resources to accelerate the industrialization process of subsequent innovative achievements. The company has established biologics drug research and development centers in both China and the United States, and has built an international R&D system and talent team that meet development needs. It has also established a comprehensive supporting team for drug clinical trials and regulatory submissions, and is capable of undertaking the entire process of new drug research — from project evaluation and initiation, new drug screening, API and formulation process development, to quality standard establishment, clinical research, and registration. The company has established a high-standard large molecule drug manufacturing system aligned with international practices, capable of meeting drug production quality requirements of different countries and regions. Its subsidiary, the Beijing Evive manufacturing site, has successfully passed GMP certifications from China’s NMPA, the U.S. FDA, and the European EMA. It is also one of the few biopharmaceutical API manufacturing sites in China that has obtained commercial production licenses and passed GMP inspections from the regulatory authorities of China, the United States, the European Union, and Brazil. The company is actively building and strengthening its international business team for large molecule drugs, with extensive experience in international market access, business negotiations, and partnership expansion. It continues to broaden its product portfolio through product licensing transactions and other means. As of now, the company’s first innovative biologic drug, Ryzneuta, has been approved for marketing and sales in 34 countries, including China, the United States, the European Union, and Brazil. 2、Small Molecules (Chemical Medicines) Field We base our endeavors on "Specialty raw materials and high-end excipients," focusing on a differentiated pharmaceutical product chain characterized as "Small, Precise, and Unique", and possess a sophisticated research and development manufacturing platform for chemical drugs along with a high-standard quality management system that aligns with international standards. In terms of products, our research and development and manufacturing encompass a range that includes dinazone oral suspension, oxytocin injection, , nimodipine injection, phloroglucinol injection, methocarbamol injection, famotidine injection, and neostigmine methylsulfate injection, fully addressing the diverse needs of the market.During the reporting period, we completed the registration application for 7 products; the production line for small-volume injectables (non-terminal sterilization) successfully passed the EU GMP on-site inspection and was awarded the GMP certificate; the chemical drug research and development center advanced multiple R&D projects, accumulating the completion of 85 key milestones, reflecting a growth of 13.3% compared to 2023. 3、Traditional Chinese Medicine Sector Traditional Chinese medicine is a traditional area of strength for Yifan Pharmaceutical, leveraging the competitive edge of "exclusive varieties and the basic drug catalog under health insurance", advancing through a dual approach of policy-driven initiatives and international expansion. We possess 104 approved numbers for traditional Chinese medicine, including Baixuekang (Compound Huangdai Tablets), Xiao'er Qingqiao Granules, moisture-removing itch-relieving ointment, Piminxiao Capsules, Fuyinkang Lotion, and 14 exclusive traditional Chinese medicine products under health insurance, 6 from the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List, 1 national second-class protected traditional Chinese medicine Variety, 1 from the World Health Organization's Essential Medicines List, and 5 registered varieties overseas. During the reporting period, we enriched our product matrix in the advantageous field of traditional Chinese medicine. There are 17 ongoing projects, of which 5 are new drugs and improved formulations (including 1 newly initiated project), 5 are classic prescriptions, 6 are secondary developments, and 1 is for the protection of traditional Chinese medicine. 4、Synthetic Biology Field The company is one of the leading manufacturers and suppliers of Vitamin B5 and its raw products globally, employing a flexible sales strategy that primarily focuses on direct sales, supplemented by distribution. Over 70% of its products are sold to various countries and regions, including Europe and America, maintaining a leading position in the global market for many years.During the reporting period, the company's self-developed vitamin new product processes underwent continuous optimization, resulting in a significant enhancement of technical indicators. The leading products showed remarkable progress in quality improvement, cost reduction, and efficiency enhancement, thereby strengthening product competitiveness. Simultaneously, the existing production technology has improved significantly compared to the year 2023, with multiple technological achievements successfully implemented.
Full description
Yifan Pharmaceutical is an innovative R&D and manufacturing company focusing on the pharmaceutical and healthcare sectors. Yifan is committed to advancing the scientific validation of possible solutions with equal emphasis on classical findings and time-proven innovations, and emerging as a new contributor of expertise in the global pharmaceutical and healthcare industry. With the 5 research centers located in San Francisco, Shanghai, Beijing, Hangzhou and Hefei, Yifan is focusing on four business sectors, biologic products, small molecules, synthetic biologics and characteristic TCMs. By fully integrating high-quality innovation resources both at home and abroad, and making continuous efforts in innovation and R&D, the company has initially built a differentiated, diversified and competitive product R&D pipeline that not only meets clinical needs but also has commercial values, covering nearly 50 products under research, such as new drugs, biosimilars, generic drugs, TCMs, and synthetic biological products. Focusing on hematologic maliganancies, inflammatory, endocrinology/metabolic, dermatological, gynecologic and pediatric diseases, etc., we have built an innovative drug development platform based on both eukaryotic expression and prokaryotic expression systems, and preparation technology platforms integrating R&D and production of oral slow controlled release preparations, micron suspension, micelles for injection, high-end complex liquid preparations, etc. Centering on the fields of special raw materials and excipients for medical use in such categories as vitamins, antivirals, cytotoxics and contrast agents, we have built R&D technology platforms for raw materials and excipients for medical use, such as continuous flow reaction, solid phase peptide synthesis, and highly active cytotoxicity, and have put forth efforts to build an innovative R&D system for the whole industrial chain ranging from raw materials and excipients for medical use, special intermediates to pharmaceutical preparations. In addition, we have actively carried out project cooperation with top synthetic biologics companies both at home and abroad, possessed a complete and efficient industrial scale-up technology system of synthetic biologics, and gained cost and scale advantages with disruptive technologies in a sustainable manner. With forward-looking strategic planning and excellent resource integration capability, we have built more than ten manufacturing bases of drup products both at home and abroad that meet the requirements of cGMP specifications such as NMPA, FDA and EMA, and have built more than 100 production lines for various dosage forms, which are equipped with sophisticated pharmaceutical production facilities and quality and laboratory management systems. Keeping abreast of the highest standard in the industry and international standards, an industrial supply chain system synchronizing internal supply with external CMO has taken shape to support large-scale commercial production of our products on sale and under development. To improve the accessibility of valuable drugs to global patients, and for patients in every corner of the world to obtain reliable and affordable therapeutic drugs and regain health, we actively promote the construction of a sound and extensive global network for commercialization, so that domestic high-quality drugs can be exported and overseas high-quality drugs can be introduced to China. At present, we have provided business services in more than 40 countries and regions in Southeast Asia, Europe and North America, including Singapore, South Korea, Italy, China, Germany, and the United States. Looking forward, Yifan people will maintain a calm state of mind, stick to critical thinking and enterprising spirits, and hold on to our original aspirations, so as to pursue steady growth and make further contributions to the elimination of human diseases.