Key points of investment
A leading domestic innovative biomedical enterprise. The company was founded in August 2011 by Dr. Yu Dechao, a national special expert of the China Organization Department's Thousand Talents Program, and others. It is a leading domestic R&D and production enterprise for innovative monoclonal antibodies. The company has established strategic partnerships with many world-renowned pharmaceutical companies such as Lilly, Adimab, and Hanmei Pharmaceutical, and its R&D capabilities have been widely recognized. Its fully integrated biopharmaceutical platform already covers all key biopharmaceutical development functions, including drug discovery, process development, analytical science, quality control and assurance, clinical development, manufacturing, and commercialization.
The domestic monoclonal antibody industry is on the rise. In particular, the market prospects for PD-1 monoclonal antibodies and bioanalogues are promising. As more monoclonal antibodies are included in the national health insurance drug catalogue, sales revenue of China's monoclonal antibody market is expected to maintain a compound annual growth rate of 42.6% in 17-22, exceeding the overall biopharmaceutical market. PD-1 monoclonal antibodies have many advantages over traditional cancer treatments represented by chemotherapy drugs. The range of indications continues to expand, and the global market is growing rapidly. On the other hand, biosimilar drugs are economical and effective alternatives to high-priced branded biopharmaceuticals, providing therapeutic efficacy not inferior to the original research products at lower prices, and market demand is strong. Currently, PD-1 monoclonal antibodies and bioanalogues have not been marketed and sold domestically, and they all have huge market prospects.
Innovation drives development, and pipeline enrichment has great potential. Over the past 7 years, the company has established a product pipeline composed of 17 antibody drug candidates. Of these, 4 core products that have entered advanced clinical development in China are dominant, and a total of 9 products have received CFDA clinical trial approval. Cindilizumab (PD-1) has officially submitted a listing application to the CFDA. It is expected to be the first batch of PD-1 monoclonal antibodies marketed and sold domestically. The first-mover advantage will help seize domestic market share. Its efficacy, safety, etc. in clinical trials are comparable to those of approved PD-1 antibodies, and it has higher binding affinity and higher target share, and has the potential to become the best product in its class. Currently, extensive clinical trials for various cancer indications have been carried out, which is expected to continue to contribute to growth impetus. The company's biosimilar drugs of rituximab, adalimumab, and bevacizumab all have indications and are currently in phase 3 clinical trials in China. Progress is at the forefront. It is expected that they will be approved for listing in the first batch in China, giving priority to seizing the broad domestic market. Five innovative monoclonal antibody products have entered the clinical research stage, and the potential is promising.
Risk warning: financial outlook risks; risks related to the development, clinical trials and regulatory approval of drugs under development; risks associated with commercialization of drugs under development, etc.
