Shanghai Haiyan Pharmaceutical Technology Co., Ltd. is the chemical innovative drug R&D center of YRPG. Located in Zhangjiang, Shanghai, it covers an area of 2,400 square meters. Established in May 2011, the company focuses on the R&D of innovative small molecule chemical drugs and is capable of independently conducting the whole pipeline research of innovative drugs, including new molecule design and synthesis, pharmacology, toxicology, DMPK (Drug Metabolism and Pharmacokinetics), pharmacy, etc. It has developed molecular generation platforms for protein degradation (PROTAC), bioconjugation (ADC - Antibody-Drug Conjugates, AGC - Antibody-Glue Conjugates), traditional small molecules and computer-aided drug design (CADD). The company has nearly 20 ongoing projects in areas such as oncology, neurology, immunology, and the digestive tract, with several projects in the clinical research stages. In addition, one innovative product, Levoornidazole Disodium Phosphate for Injection, has been approved for production and included in the medical insurance. Two other products, namely Tononadif Hydrochloride Tablets (for male erectile dysfunction) and Fexuprazan Hydrochloride Tablets (for reflux esophagitis), have been submitted for production approval. The company has completed the pre-production communication for YZJ-1139 (a sleep aid) and is about to apply for production approval. It is expected to become the second dual orexin receptor antagonist product to be launched in China, bringing good news to nearly 300 million young insomnia patients. 

While focusing on R&D, the company actively applies and evaluates government projects and has won numerous enterprise-level honors. In 2017, for the first time, it was certified as a "High-tech Enterprise" by the Ministry of Science and Technology, the Ministry of Finance, and the State Taxation Administration, and it successfully passed the re-evaluations in 2020 and 2023. Meanwhile, the company possesses multiple invention patents and has been recognized as a " Demonstration Enterprise for Patent Work in Shanghai" by the Shanghai Intellectual Property Administration. 

Shanghai Hailu Biotechnology Co., Ltd. is the biopharmaceutical R&D center of YRGP. Located in Zhangjiang, Shanghai, it covers an area of 5,000 square meters. Established in August 2015, the company focuses on the R&D of biological macromolecular drugs. It has established a full-process preclinical biopharmaceutical R&D platform for antibody discovery, antibody engineering, in vitro function, in vivo efficacy, process development, and quality analysis. The company has also developed multiple technological platforms for monoclonal and bispecific antibodies, T cell engager (TCE) bispecific antibodies, next-generation conjugation technologies (ADC - Antibody-Drug Conjugates, ARC - Antibody-conjugated siRNA, AXC - Site-specific Antibody-Drug Conjugates), and nucleic acid drugs. The company has more than 10 ongoing projects in such areas with significant clinical needs as oncology, autoimmunology, and neurology. Several projects are in preclinical development and antibody discovery stages, with the progress ranking among the top three domestically and globally. In December 2020, the company was recognized as the "Shanghai Engineering Technology Research Center for Immunotherapy Drugs" by the Science and Technology Commission of Shanghai Municipality. 

Since the State Council called for accelerating the consistency evaluation of generic drugs in 2015, YRPG has quickly responded and planned ahead. As of October 2024, the Group has 171 generic drugs that have passed or are deemed to have passed the consistency evaluation. Among the 171 generic drugs, 37 passed for the first time in the industry, and the number of generic drugs that have passed the consistency evaluation ranks among the top in China. In the first nine rounds of centralized procurement, 51 drugs were selected, achieving import substitution and saving significant costs for national health insurance and patients.

In the new situation, the company focuses on developing next-generation novel delivery systems (NDDS), complex formulations, and high-end raw materials to enrich and strengthen the product pipeline, breaking through the homogenization dilemma. The company is actively developing technological platforms for liposomes, in-situ gels, microcrystals/nanocrystals, inhalation, transdermal delivery, peptides, and lipid nanoparticles (LNP), as well as first and early generic products, to build a product pipeline to address future challenges rapidly. At the same time, the company will accelerate the internationalization of the products to gain a competitive edge in the international market and achieve multi-point sustainable development.

Shanghai R&D Base

The Shanghai R&D base is located in the R&D building of Shanghai Haini Pharmaceutical Co., Ltd. in the Pudong New District of Shanghai. The building covers an area of 6,500 square meters and employs more than 40 staff, including 5 with doctoral degrees. As a national key laboratory for transforming high-end formulation achievements and cultivating talent, the Shanghai R&D base mainly focuses on the R&D of liposome-modified drugs. It has established a cell laboratory and platforms for liposome formulation and analytical research.

Taizhou R&D Base

The Taizhou R&D base is in a 16-story R&D building of Yangtze River Pharmaceutical Group Co., Ltd. in Taizhou City, Jiangsu Province. As a functional building integrating experimental research, office management, and material storage, the R&D building covers about 33,000 square meters. The company boasts nearly 250 R&D staff, including 5 with doctoral degrees and 10 associate professors or professors. Equipped with various types of functional experimental platforms, including formulation laboratories, quality research laboratories, and synthesis laboratories, the Taizhou base is dedicated to developing technological platforms for first and early generic drugs, long-acting injectables (including nanocrystals and in-situ gels), emulsions, and so on.

Nanjing R&D Base

The Nanjing R&D base is in Nanjing Hailing Pharmaceutical Co., Ltd. in the Qixia District of Nanjing City. The company covers an area of about 16,000 square meters. The Nanjing R&D base is a practice base for postgraduates with professional degrees from China Pharmaceutical University and Lanzhou University, with over 110 R&D staff. Based on the Group's characteristic disease areas and production lines, the base has established a platform development strategy centered on inhalation formulation technology, transdermal delivery technology, and peptide drug development. By building a core platform with high-tech barriers and developing a batch of high-barrier complex formulations, the base aims for distinctive and differentiated development, positioning its R&D at the forefront in China. Meanwhile, the base is advancing the internationalization of peptide products in line with the Group's globalization strategy.

National Key Laboratory of High-end Formulations for Overcoming Drug Delivery Barriers

The National Key Laboratory of High-end Formulations for Overcoming Drug Delivery Barriers (hereinafter referred to as the Laboratory) is a national research platform jointly reorganized by YRPG and Fudan University in March 2023. Formerly known as the National Key Laboratory of New Drug Formulation Technologies, it is among the first batch of national key enterprise laboratories. Since its establishment was approved by the Ministry of Science and Technology in 2007, the Laboratory has always been committed to innovative R&D in pharmaceutical formulations.

The Laboratory conducts theoretical research, formulation technology studies, and development of advanced formulation products focused on overcoming physiological and pathological barriers in drug delivery, including oral delivery, and intravenous and local injections. The Laboratory aims to become a domestically leading and internationally advanced R&D technology platform for high-end formulations and a transformation base for achievements, contributing significantly to enhancing the new quality productive forces of biomedicine and realizing the strategic goals of the Healthy China Initiative and Pharmaceutical Powerhouse.

The laboratory has gathered a group of high-level research talents, with 150 permanent staff, including 66 with doctoral degrees and 20 selected for the provincial or higher-level talent programs. In 2023, the Laboratory witnessed 4 new members added to the talent programs at the provincial, ministerial, or higher level and trained 258 postgraduate students, all dedicated to overcoming drug delivery barriers and promoting innovative development of the biopharmaceutical industry.

Looking ahead, the university and the enterprise will continue to deepen cooperation and work together on the construction and development of the National Key Laboratory, striving to achieve more fruitful results in areas such as scientific research innovation and talent cultivation and contributing even more to the progress of China's pharmaceutical and scientific research.

Beijing Haisha Consulting Co., Ltd., established in 2011, is a wholly-owned subsidiary of YRPG. To " build a world-class clinical R&D platform, " the company conscientiously implements the strategic guidelines of the Institute of Pharmaceutical Sciences, focusing on the scientific initiation of clinical projects and the high-quality, efficient implementation of these projects. The company actively promotes the development of clinically valuable products. It mainly undertakes Phase I, II, and III clinical trials and bioequivalence trials for the headquarters of the Group and subsidiaries.

Since its establishment, the company has undertaken over 100 clinical trials covering multiple therapeutic areas, including anesthesia, oncology, anti-infection, andrology, digestion, sleep, and endocrinology. The company employs over 170 people, with offices nationwide in over ten locations, including Beijing, Shanghai, and Nanjing. It has established a matrix management system with multiple departments, including medical science, clinical operations, biostatistics, clinical pharmacology, pharmacovigilance, quality management, and R&D management, enabling collaborative operations across modules.

Overview

With the Taizhou TCM Institute as the center, there are two TCM institute branches in Nanjing and Taizhou. The current staff exceeds 70, with over 60% holding master’s degrees or doctoral degrees, covering various drug innovation and R&D fields, including natural pharmacology, pharmaceutics, analysis, pharmacology, and clinical studies. Since its establishment, the Institute has obtained 9 exclusive production approvals for Chaiqin Qingning Capsule, Shuanghua Baihe Tablet, Shenqu Xiaoshi Oral Liquid, Baiai Capsule, Qingping Granules, Lingxiong Capsule, Sanfeng Tongqiao Dripping Pills, Lianyu Burn Ointment, and Shangle Aerosol; additionally, the Institute has acquired clinical licenses for 4 new drugs.

The R&D of TCM includes innovative drugs, modified drugs, maintenance of existing TCM registration numbers, and the development of medicines with the same name and formula. Among these, developing creative and modified drugs covers areas where TCM has advantages, such as digestive disorders, respiratory diseases, peri-tumor chronic diseases, ophthalmology, neuropsychiatry, and pediatrics. The categories include TCM compound formulations, extracts from single plant sources and their formulations, as well as new medicinal materials and their formulations. The maintenance of existing TCM registration numbers includes expanding new indications and new dosage forms of existing products, applying for TCM protection, expanding basic research and evidence-based studies, defending large varieties of medicines with the same name and formula, and selecting high-potential TCMs for the R&D of large varieties with the same name and formula.

R&D platforms for TCM

The Group has established the "National Engineering Research Center for Traditional Chinese Medicine Pharmaceutical Technology" and the "Key Research Laboratory for Traditional Chinese Medicine Quality Control". Since 2002, the Group has invested over RMB 100 million to establish the Nanjing Hailing National Engineering Research Center for Traditional Chinese Medicine Pharmaceutical Technology in collaboration with institutions such as Nanjing University, Beijing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing University of Science and Technology, and China Pharmaceutical University, and has received project support from the National Development and Reform Commission. The research center takes modern pharmaceutical engineering research for TCM as its central direction, focusing on solving technical problems in such key areas as industrial extraction, separation, purification of effective ingredients, practical parts, and effective monomers of TCM, as well as quality control of intermediates and formulations. The Group strives to standardize production processes, establish quality standards for products, and enhance the intelligence of processing equipment, thereby improving the manufacturing level and international competitiveness of China's TCM industry.

The Key Laboratory for TCM Quality Control of the National Administration of Traditional Chinese Medicine, established on April 11, 2011, relies on YRPG. The main research directions of the Laboratory include: 1) quality control of TCM based on chemical components-biological activities;2) improvement of quality standards for TCM;3) international and mutual recognition of quality standards for TCM.

TCM Internationalization

Leveraging the platform advantages of the national “Key Laboratory for TCM Quality Control,” YRPG gathered renowned experts in TCM standard research to integrate new technologies and methods from various disciplines such as TCM chemistry, TCM analytics, and chemometrics. As a result, a “Comprehensive Quality Standard System for Traditional Chinese Medicine” suiting the complex characteristics of TCM systems was established and has been successfully applied to the quality standards of over 20 TCM varieties included in the China Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia, significantly enhancing the international exchange of TCM.

On June 24, 2011, the State Administration of Traditional Chinese Medicine (SACCM), the European Directorate for the Quality of Medicines and Healthcare (EDQM), and the YRPG Key Laboratory for Quality Control of TCM (NKI-TCM) signed a tripartite cooperation agreement to jointly work on the research of Chinese herbal medicine quality monographs for the European Pharmacopoeia. YRPG is currently responsible for researching 15 plant monographs of TCM materials for the European Pharmacopoeia. Among these, the research results for 5 varieties, including Persicaria orientalis, Polygonum cuspidatum, Houttuynia cordata, Eupatorium, and Folium Isatidis, have been publicized and included in the European Pharmacopoeia. Since China participated in the research, Folium Isatidis became the first TCM variety included in the European Pharmacopoeia.