R&D Center

 

Scientific research strength
We have established an efficient R&D system that enables us to continue to develop investigational drugs in high-potential therapeutic areas such as metabolic diseases, orthopedics, oncology and hematology. Through more than 30 years of accumulation, our R&D team has accumulated extensive professional knowledge in the fields of new drug discovery, efficacy evaluation, process and quality research, preclinical research, clinical research and regulatory filing.
Our R&D team has approximately 110 people, more than 60% of whom have master's and doctoral degrees, covering multi-disciplinary backgrounds. The main members of the R&D team have an average of more than 20 years of experience in the pharmaceutical industry. Due to our strong R&D capabilities, we participate in multiple national or provincial research projects. We have undertaken three major national science and technology projects, and our marketed products have won a total of 11 national honors. After 30 years of R&D efforts, we have established six product development platforms: recombinant protein drug technology platform, peptide drug technology platform, innovative drug-device combination technology platform, antibody drug technology platform, long-acting technology platform and subcutaneous drug delivery technology platform, allowing us to continue to develop and advance pipeline products.

 

 1.Recombinant protein drug technology platform

 

 

We use three mature protein expression systems, namely E. coli expression system, yeast expression system and mammalian cell expression system, to produce functional recombinant therapeutic proteins. Using protein expression systems, we have produced a number of drugs that are already on the market and in clinical stages (such as Jilifen, Jijufen and JY06 (Jixinfen)).

 

 

 

2.Peptide drug technology platform

 

 

We began to develop peptide drugs in 2005 and have since established strong capabilities in the research and development, process development and production of peptide drugs. In addition to JY29-2 and the liraglutide biosimilar subsequently known as Lilupin, we are also developing amylin analogs and dulaglutide biosimilars using our peptide drug technology platform.

 

 

 

3.Innovative drug-device combination technology platform

 

 

We have combined recombinant proteins with biological materials to establish a drug-device combination technology platform. We have developed China's first commercialized rhBMP-2 bone repair material product Guyoudao, and are using this technology platform to continue to develop a new generation of bone repair materials. Higher performance bone repair materials.

 

 

 

 

4.Antibody drug technology platform

 

 

Our comprehensive antibody drug technology platform covers the key steps needed to develop antibody drugs, effectively advancing the development process that begins with the discovery and optimization of innovative antibodies. Up to now, we have obtained IND approval for two investigational antibody drugs, including the Class 1 innovative antibody investigational drug JY47 and the antibody biosimilar investigational drug JY43. JY47 is a SIRPα-specific monoclonal antibody proposed for the treatment of advanced solid tumors, while JY43 is a targeted monoclonal antibody proposed for the treatment of multiple myeloma. We are also developing JY41 (Antibody biosimilar), an osteosclerosis inhibitor intended for the treatment of osteoporosis. In addition, we continue to combine and improve dosage forms around innovative antibodies. In addition to developing our own antibody products, we also provide preclinical research and development services to other pharmaceutical companies. An investigational antibody drug developed using our R&D services has entered phase III clinical trials.

 

 

 

5.Long-term technology platform

 

 

Protein and peptide drugs generally require frequent administration and injection. In order to improve patients' convenience and compliance with medication, we use various long-acting technologies, including fatty acid chain modification, polyethylene glycol (PEG) modification and FC fusion, which can extend the half-life of the drug and achieve long-lasting therapeutic effects. The semaglutide biosimilar JY29-2, which we developed and modified using lipidation technology, completed the Phase III clinical trial for the treatment of T2DM in October 2023, and was approved for clinical trial for the treatment of obesity and overweight in January 2024. In addition, we have submitted an NDA application to NMPA in May 2023 for the G-CSF product JY06 (Jixinfen) modified with PEGylation technology. We also provide preclinical drug development services to other pharmaceutical companies with our long-acting technology. An investigational insulin detemir drug developed using our lipidation technology has received IND approval.

 

 

 

6.Subcutaneous drug delivery technology platform

 

 

For parenteral administration, a large number of adverse events are associated with intravenous administration. Switching to subcutaneous injection of drugs can effectively reduce the risk of adverse events and improve patients' tolerance to the drugs. Our platform focuses on subcutaneous drug delivery using recombinant hyaluronidase. Hyaluronidase can temporarily hydrolyze subcutaneous hyaluronic acid, thereby improving the dispersion and penetration of drugs in tissues and improving the bioavailability of drugs. Therefore, combining hyaluronidase with active substance allows large-dose drugs that originally need to be delivered through intravenous administration to be administered subcutaneously, thus providing patients with a safer and more convenient option. We have independently developed recombinant hyaluronidase JY53 and expect to submit a drug master file (DMF) registration application for JY53 as an excipient in 2024. Based on this platform, we are conducting preclinical research on the daratumumab biosimilar JY43-2. JY43-2 contains recombinant human hyaluronidase and can be injected subcutaneously.

 

The company attaches great importance to the construction of intellectual property strategy, has a professional intellectual property management department, and has formulated a variety of policies to encourage technological innovation and intellectual property protection. The company was rated as a patent demonstration enterprise in Zhejiang Province in 2010. In October 2014, it obtained the "Intellectual Property Management System Certification Certificate" issued by Zhongzhi (Beijing) Certification Co., Ltd. (passed re-certification in 2020). In October 2015, it was awarded the "Intellectual Property Management System Certification Certificate" by the National Intellectual Property Administration. The company attaches great importance to intellectual property protection and carries out a comprehensive patent layout for R&D projects. We hold 15 registered patents and eight pending patent applications in China, and two pending PCT applications. We have received multiple awards and recognitions, including 3 patents that won the "China Excellent Patent Award".