AI-Driven Biopharmaceutical R&D Company Development Directions
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Biopharmaceutical raw materials primarily consist of natural biological materials, including microorganisms, humans, animals, plants, and marine organisms. With advancements in biotechnology, purposefully engineered biological materials have become a major source of biopharmaceutical ingredients, such as animal-derived materials produced through immunological methods or microbial/cellular materials with modified genetic structures.
2023 Biopharmaceutical Growth Trends and Future Directions
Recently, a business-focused biopharmaceutical special issue by Nature published an article titled Understanding the company landscape in AI-driven biopharma R&D, which explores the growth trends and future directions of AI-driven biopharmaceutical R&D companies in recent years.
The advancement of artificial intelligence (AI), combined with the increased availability of biomedical data, is revolutionizing drug discovery and development. Initially focused on areas such as small-molecule drug design and target identification through literature analysis, AI tools are now being developed for all stages of the research and development (R&D) pipeline and across multiple therapeutic modalities. Breakthroughs like AlphaFold2 in protein structure prediction have added new momentum to the field, while progress in foundational models is opening up new possibilities across data domains, including images, text, omics, and chemistry.
As a result, AI-based tools are currently regarded by the biopharmaceutical industry as one of the key 'engines' for discovering and developing innovative drugs. Large biopharmaceutical companies are building AI capabilities through three parallel approaches.
First, major biopharmaceutical firms are establishing in-house AI expertise, including through collaborations with information technology companies. For example, in 2019, pharmaceutical giant Novartis and tech giant Microsoft announced a multi-year partnership to leverage Novartis's datasets and Microsoft's AI tools for discovering, developing, and commercializing new drugs. They also established an AI innovation lab to support researchers across Novartis.
Secondly, acquiring AI-powered biotech companies has become a fast track for pharmaceutical giants to obtain AI capabilities. Typically, these acquisitions target firms specializing in AI tools and datasets for specific aspects of drug development. For instance, Roche acquired Prescient Design in 2021 (a startup using generative models for antibody design), while BioNTech recently announced a £362 million upfront payment to acquire InstaDeep (a company specializing in protein design through deep learning and reinforcement learning). These deals often provide biopharma companies with experienced personnel in bioinformatics, data science, and engineering, along with access to proprietary databases.
Thirdly, biopharmaceutical companies are establishing partnerships with AI-driven biotech firms to identify and co-develop drug candidates. The most valuable deal in recent years was the December 2021 collaboration between Recursion and Genentech/Roche, which uses Recursion's AI-powered high-throughput screening platform to identify new targets and drugs in neuroscience and oncology. Recursion received $150 million upfront, with potential milestone payments of $300 million per project for up to 40 research programs, potentially totaling $12 billion. In January 2022, Exscientia struck another major deal with Sanofi to develop up to 15 drug candidates in oncology and immunology using Exscientia's AI-powered precision medicine platform, with $100 million upfront and potential payments reaching $5.2 billion.
The Landscape of AI-Driven Biotech Companies
AI-driven biotech companies are clearly playing a prominent role in the application of AI across the industry.
China Biologic Products has entered into a collaboration agreement with Hongyun Huaning (Hangzhou) Biopharmaceutical Co., Ltd. (hereinafter referred to as Hongyun Huaning) to jointly develop the dual-target weight-loss innovative drug GMA106. Hongyun Huaning will receive up to $57 million (approximately RMB 408 million) in upfront and milestone payments from the deal, while China Biologic Products will obtain exclusive development and commercialization rights for GMA106 in Greater China.
China Biologic Products stated that the introduced GMA106 is a GIPR (glucose-dependent insulinotropic polypeptide receptor) antagonist/GLP-1R (glucagon-like peptide-1 receptor) agonist.
Regarding efficacy, China Biopharmaceuticals stated that the latest Phase 1 clinical data for AMG133, which shares the same target and mechanism of action as GMA106, showed that the high-dose group of AMG133 achieved a 12-week weight loss effect of 14.52%, outperforming the 6% weight loss observed in the semaglutide 2.4mg group over the same period. This result is also close to the 16.0% weight loss achieved by Eli Lilly's Tirzepatide 5mg group over 72 weeks in previous trials.
Tianyancha records show that Hongyun Huaning was established in 2010 in Hangzhou, Zhejiang Province, and is primarily engaged in research and experimental development.
Regarding GMA106, the subject of the collaboration with China Biopharmaceuticals, Hongyun Huaning stated on its official website that GMA106 is primarily indicated for obesity, non-alcoholic fatty liver disease, and diabetes. The project commenced Phase I clinical trials in Australia in November 2021. In March 2022, it received implicit clinical trial approval from China's National Medical Products Administration, with plans to conduct clinical trials in China. On November 24, 2022, GMA106 completed the first dosing for all subjects in the first dose group of its Phase Ib clinical study in Australia.
The market space for GLP-1 drugs in diabetes patients is expected to exceed 25 billion yuan, while the market for obesity treatment applications is projected to surpass 20 billion yuan.
According to the 'Global Obesity Drug Competitive Landscape Analysis Report' from Dingxiangyuan Insight Database, there are currently 27 clinical research projects targeting GLP-1 class obesity treatment drugs. The pharmacological types are mainly peptides, with other categories under research including antibody fusion proteins, monospecific antibodies, and small molecule chemical drugs. Currently, no obesity indication drugs targeting this pathway have been approved in China, but multiple companies have already entered this competitive and crowded field.
Beyond single-target GLP-1 drugs, dual-target and multi-target drugs based on GLP-1R are gaining traction in the fields of glucose reduction and weight loss. Guojin Securities analysis indicates that most global multi-target agonists in development focus on GLP-1R/GIPR and GLP-1R/GCGR combinations. Among these, Eli Lilly's tirzepatide leads the GLP-1R/GIPR field and has already received FDA approval. GLP-1R/GIPR/GCGR triple-target agonists may demonstrate even stronger efficacy, with Eli Lilly and Hanmi Pharmaceutical advancing their respective products to Phase II clinical trials.
Regarding future sales plans, China Biopharmaceuticals stated that for the GLP-1 target, the clinical application for Semaglutide Injection submitted by Zhengda Tianqing on June 7 has been accepted by the CDE. Additionally, one Liraglutide Injection has already been submitted for marketing approval. The sales peak for the newly introduced GMA106, upon successful launch in China, is expected to exceed 2 billion yuan.