1.The 2026 Landscape of In Vivo CAR-T Therapy
At the transaction level, multinational pharmaceutical companies (MNCs) are aggressively securing their positions through high-value acquisitions (e.g., Lilly’s $2.4 billion acquisition of Orna and AbbVie’s $2.1 billion acquisition of Capstan). Technical approaches are diverging: lentiviral vectors (characterized by targeted T-cell modification and genomic integration for long-term expression) dominate in cancer treatment, with representative companies including Umoja, EsoBiotec, and Legend Biotech; lipid nanoparticle (LNP) vectors (non-integrating, safer but with insufficient expression durability) lead in autoimmune disease treatment, represented by companies such as CREATE, Capstan, and JiaChen West Sea. In terms of clinical progress, the lentiviral approach is ahead, with Umoja and Interius entering Phase I clinical trials, and EsoBiotec showing preliminary efficacy in multiple myeloma. Companies using the LNP approach are gearing up to initiate clinical trials. Competition within China is thriving: SYS6055 from CSPC Pharmaceutical Group is the first in vivo CAR-T therapy approved for clinical trials in China; companies like JiYin Bio, Hongxin Bio, Legend Biotech, and PuriGen occupy significant positions in global competition through differentiated technologies (e.g., IITCR, SLE data, dual-target design, and collaborations with MNCs). The article concludes that 2026 will be a critical turning point for the field as it transitions from proof-of-concept to scaled clinical trials.
2. American Society of Clinical Oncology Releases Updated Guidelines for the Treatment of Advanced Gastric and Esophageal Cancer
New guidelines emphasize precision stratified therapy based on biomarkers (PD-L1, dMMR/MSI-H, HER2, CLDN18.2). First-line treatment: For HER2-negative pMMR/MSS gastric/gastroesophageal junction/esophageal adenocarcinoma, immunotherapy combined with chemotherapy is recommended for PD-L1≥1; zolbetuximab combined with chemotherapy is recommended for CLDN18.2-positive but PD-L1<1. For HER2-positive pMMR/MSS patients, pembrolizumab combined with trastuzumab and chemotherapy is recommended for PD-L1≥1. dMMR/MSI-H patients may choose immunotherapy combined with chemotherapy or single-agent immunotherapy. For esophageal squamous cell carcinoma, immunotherapy combined with chemotherapy or nivolumab combined with ipilimumab is recommended for pMMR/MSS and PD-L1≥1. Second-line treatment: ramucirumab combined with chemotherapy is recommended for pMMR/MSS HER2-negative patients; trastuzumab deruxtecan is recommended after the failure of first-line treatment for HER2-positive patients. The guidelines reflect the reshaping of clinical practice by recent breakthroughs in immunotherapy and targeted drugs, marking the official entry of advanced gastroesophageal cancer into the era of biomarker-driven precision therapy.
3. China's AI pharmaceuticals accelerate, with increased financing and IPOs, deep ties with multinational pharmaceutical companies, and strong policy support.
Financing and IPO: Helixon (EarendilLabs) overseas entity completed a $7.87 billion financing round, setting a global biotech financing record for 2026, and plans to go public in Hong Kong. Its investors include strategic investments from multinational corporations (MNCs) such as Sanofi and Pfizer, indicating a shift from "project collaboration" to "capital and ecosystem binding." Industry collaboration: From licensing partnerships to strategic investments, multinational pharmaceutical companies are securing leading technologies of Chinese AI platforms through various means, such as AstraZeneca establishing an AI drug discovery joint research center with Tsinghua University. Policy support: The national-level strategy for "AI + biomanufacturing" is clear, with local governments in Jiangsu, Hunan, and other regions introducing specific support policies to promote AI applications in target discovery, molecular design, and more, while providing data, platform, and industry ecosystem support. The article argues that China's AI-driven drug discovery has moved from the technical validation phase into a new stage of dual recognition by capital and industry, becoming a core force in the global pharmaceutical innovation landscape.
4.Insilico Intelligence and Eli Lilly Enter Licensing and R&D Collaboration with Total Deal Value Up to $2.75 Billion
Under the agreement, Eli Lilly will obtain the global exclusive license for a potential "best-in-class" oral therapy in the preclinical stage, intended for specific indications. Additionally, both parties will engage in multiple research and development collaborations targeting designated targets by Lilly. Insilico Medicine will receive an upfront payment of $115 million and is eligible for subsequent development, regulatory, and commercial milestone payments, as well as royalties based on sales. The collaboration aims to leverage Insilico Medicine’s AI drug discovery platform, Pharma.AI, combined with Lilly's expertise in disease areas, to accelerate the discovery and development of new drugs across multiple therapeutic fields. The article also highlights Insilico Medicine's robust R&D pipeline, which includes over 20 programs generated by its AI platform, covering areas such as fibrosis, oncology, and immunology. Its core assets (e.g., ISM001-055 targeting TNIK) are at the forefront of similar global R&D efforts. This collaboration once again demonstrates the global competitiveness of China's AI pharmaceutical platforms.
5.2025 China's Innovative Drug Out-Licensing (BD) Transaction Boom
In the first three months of 2026, the total amount of China's innovative drug out-licensing has exceeded $600 billion, approaching half of the total for the whole year of 2025 ($1.3 trillion), with upfront payments surging 187% over five years. The article points out that three revolutionary therapies are the core drivers of growth: ADCs (antibody-drug conjugates), leveraging a "precision missile" mechanism, have become an area of Chinese strength; GLP-1 receptor agonists have evolved from weight-loss drugs to "comprehensive management drugs for metabolic chronic diseases," showing enormous market potential; CAR-T cell therapy is nearing "functional cures" in hematological tumors. On the policy front, dynamic adjustments to the medical insurance catalog, expedited review and approval processes, and support under the 15th Five-Year Plan have formed a "super accelerator." The article argues that the surge in the value of China's innovative drugs stems from improved clinical data quality, large patient sample sizes, enhanced source innovation capabilities, and multinational pharmaceutical companies' pipeline supplementation concerns. China is transforming from a "terminal manufacturer" in the global pharmaceutical industry chain to a "source innovator," a shift that is occurring at least five years earlier than expected.
6. 107 New TCM Drug Varieties Approved for Clinical Trials in 2025
Overall Characteristics: Registrations are dominated by Class 1.1 innovative traditional Chinese medicines (new compound prescriptions), accounting for 62.6%, indicating that research and development is primarily original. Indication Distribution: Respiratory, digestive, and nervous system diseases are the main focus of R&D, reflecting the traditional strengths of traditional Chinese medicine in chronic disease management. Applicant Types: Traditional Chinese medicine enterprises are the main force, but the participation of universities, research institutes, and medical institutions has significantly increased, making "industry-university-research-medicine" collaborative innovation an important pathway. Dosage Form Innovation: Modern dosage forms such as granules, oral liquids, and capsules are predominant, with granules being the most popular due to their convenience. Compound vs. Single Formulations: Compound formulations (83.2%) remain mainstream, but single formulations (16.8%) based on active ingredient extraction are also increasing, showing a trend towards modernization and precision. In 2025, the development of new traditional Chinese medicines will exhibit a trend of "innovation-led, diverse indications, modern dosage forms, and coordinated development," transitioning from traditional experience to scientific evidence-based practices.
7. Novo Nordisk and Salubris Reach an $850 Million Collaboration
STC007 is a non-opioid, non-antihistamine long-acting analgesic/anti-itch drug designed to treat areas with significant unmet clinical needs, such as chronic kidney disease-associated pruritus, postoperative pain, and diabetic peripheral neuropathy-related pruritus. This collaboration holds strategic significance for both parties: For Salubris, STC007 represents a crucial enhancement to its innovative pipeline in chronic diseases (especially renal complications and pain management); for Novo Shengtai, leveraging Salubris’ robust commercialization network can accelerate the market launch and penetration of this innovative drug. The article highlights that this partnership reflects a trend among China’s innovative pharmaceutical companies to "deepen and refine" efforts in niche disease areas, with its "targeted treatment" concept expected to reshape the therapeutic landscape for chronic pruritus.
