Medical Library | Shanghai Biopharmaceutical Industry Series
Shanghai's biopharmaceutical industry is moving beyond single-product competition. The next phase is being shaped by platform innovation, global clinical development, and the ability to turn scientific progress into sustainable commercialization. Across 2025 and 2026, a group of Shanghai-based and Shanghai-linked companies advanced programs in immuno-oncology, antibody-drug conjugates (ADCs), T-cell engagers, precision small molecules, and cell therapy.
This article reviews Junshi Biosciences, Henlius, HUTCHMED, Zai Lab, JW Therapeutics, CARsgen Therapeutics, Fosun Pharma, Dizal, and Yingli Pharma/Huya Bioscience. It focuses on their core technology strategies and the major milestones provided for 2025–2026, offering a concise view of the structural changes taking place in Shanghai's innovative medicine sector.
1. Moving Beyond the PD-1 Dividend
Junshi Biosciences: Extending an Immunotherapy Base into IO+ADC and Bispecific Combinations
Junshi Biosciences has built a commercial foundation around toripalimab, a PD-1 inhibitor, and is now extending that foundation into next-generation immunotherapy combinations, including ADC combinations and bispecific antibodies. According to the information provided, toripalimab combined with disitamab vedotin for HER2-positive urothelial carcinoma was approved in May 2026. This represented the product's 13th indication and was described as the first domestic immunotherapy-plus-ADC combination of its kind.
On the development side, JS207, a PD-1 x VEGF bispecific antibody, has entered Phase II studies across multiple tumor types. Junshi's current strategic characteristic is its attempt to convert an established PD-1 commercial platform into a broader combination-therapy engine, linking near-term revenue with longer-term clinical innovation.
Henlius: Combining Global Commercialization with ADC and T-Cell Engager Innovation
Henlius is pursuing the global expansion of serplulimab while developing new assets involving HER2, PD-L1, ADCs, and T-cell engagers. The information provided states that perioperative treatment for gastric cancer with serplulimab was approved in June 2026 and that the product had reached more than 40 countries. HLX22 is advancing in a multi-regional Phase III program, while HLX3901, described as a tetravalent T-cell engager, received IND clearance in March 2026.
Henlius illustrates a model in which biosimilar globalization and innovative antibody development reinforce each other. Its long-term value will depend not only on individual product approvals, but also on the company's ability to combine international registration, clinical development, and differentiated antibody platforms.
2. Precision Small Molecules and Licensing as a Second Global Growth Curve
HUTCHMED: Building a Global Small-Molecule Platform
HUTCHMED has developed a broad small-molecule strategy around VEGFR, MET, FGFR, and EZH2. According to the provided information, fruquintinib combined with sintilimab for second-line renal cell carcinoma was approved in May 2026, with a reported median progression-free survival of 22.2 months. Tazemetostat was approved in March 2025, and the global Phase III SAFFRON study of savolitinib was reported as positive for both progression-free survival and overall survival in August 2026.
HUTCHMED represents a Shanghai-linked model of global expansion built on precision small molecules and international clinical development. If savolitinib advances successfully through commercialization, it could provide a second international growth curve alongside the company's existing products.
Zai Lab: A Mature License-In and Local Commercialization Model
Zai Lab has developed a distinctive license-in and local commercialization model. The company brings in products with commercial potential, develops them for the Chinese market, and is also building internal capabilities in ADCs and T-cell engagers.
The provided information states that tisotumab vedotin, a tissue factor ADC, was approved for cervical cancer in June 2026, while repotrectinib for NTRK-positive solid tumors was approved in January 2026. Zocilmetinib, referred to in the source material as a DLL3 ADC, received orphan drug designations from the FDA and EMA. The key strategic question for Zai Lab is whether its established licensing and commercialization engine can increasingly support a differentiated proprietary pipeline, particularly in DLL3-directed ADC development.
3. Cell Therapy Enters a Commercialization and Indication-Expansion Phase
JW Therapeutics: From Blood Cancer CAR-T to Autoimmune Disease
JW Therapeutics is centered on relma-cel, an autologous CD19 CAR-T product, and continues to expand its hematologic oncology franchise. According to the provided information, a supplemental biologics license application for second-line relapsed or refractory large B-cell lymphoma was accepted for review in May 2025 and remained under evaluation. The company is also exploring autoimmune diseases such as systemic lupus erythematosus. The source material reports that an early-stage study reached a 100% SRI-4 response rate in October 2025 and that the product's frozen storage period was extended to 36 months.
For CAR-T companies, the competitive landscape is no longer defined only by the first approval. Indication expansion, manufacturing and logistics efficiency, patient access, and entry into autoimmune disease will all influence the durability of commercialization.
CARsgen Therapeutics: Taking Solid-Tumor CAR-T from Exploration to a First-in-Class Product
CARsgen Therapeutics is developing autologous CAR-T programs against CLDN18.2, GPRC5D, and GPC3. The information provided states that zevor-cel, also known as CT041, received NMPA approval on June 22, 2026, for patients with gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. It was described as the world's first approved solid-tumor CAR-T product, with an indicated price of approximately RMB 990,000.
CT071, a GPRC5D-directed CAR-T program, was reported to have published Phase I data in The Lancet Haematology in October 2025. CARsgen's broader significance lies in its attempt to address the central challenges of solid-tumor cell therapy, including target heterogeneity, the tumor microenvironment, and limited cell infiltration. The company is helping move solid-tumor CAR-T from technical validation toward product development.
Fosun Pharma: Advancing Cell Therapy through Both Partnership and Internal R&D
Fosun Pharma is pursuing a dual-track strategy that combines partnered products with internal development across CAR-T, ADC, and T-cell engager programs. Yescarta, or axicabtagene ciloleucel, reached its fifth anniversary of commercial launch in China in June 2026. The company also initiated Phase I/II studies of FKC289, a BCMA/CD19 dual-target CAR-T, in amyloidosis and membranous nephropathy. A biologics license application for equecabtagene autoleucel was accepted for review.
Fosun Pharma's advantage is its scale and ability to connect commercialization experience, external technology partnerships, and internal innovation. Key areas to watch include the clinical differentiation of dual-target CAR-T and the safety, efficacy, and affordability of cell therapy as it expands into autoimmune diseases.
4. Precision Biology and New Targets: From Single-Asset Breakthroughs to Global Rights Deals
Dizal: Testing Global First-in-Class Potential through EGFR Exon 20 Insertion Inhibition
Dizal is focused on the EGFR exon 20 insertion mutation and its small-molecule inhibitor sugemalimab, as described in the source material. The provided information states that the program received FDA accelerated approval in July 2025, that the WU-KONG28 Phase III study reported positive results in The New England Journal of Medicine in May 2026, and that Dizal signed an exclusive global licensing agreement with AstraZeneca in July 2026.
This trajectory reflects a broader path for Chinese innovative medicine companies: establish clinical and regulatory validation domestically, then secure global recognition through international development and licensing. Dizal's significance lies not only in a single approval, but also in the attempt to build a globally relevant first-in-class asset around a defined molecular subtype and an unmet clinical need.
Yingli Pharma and Huya Bioscience: New Targets alongside Global Re-Development
Yingli Pharma is pursuing emerging targets including pan-KRAS, PARG, and HIPK2. The source material identifies YL-17231, a pan-KRAS program, as the first domestic program of its class to enter a Phase I clinical trial. Huya Bioscience is taking a different route by globally redeveloping chidamide. Its global Phase III study of HBI-8000 combined with an anti-PD-1 therapy for melanoma was reported to have produced positive top-line results in July 2026, with a reported median progression-free survival of 11.7 months compared with 7.4 months in the control group.
Together, these companies represent two distinct innovation strategies. Yingli Pharma is making a focused bet on emerging biology, while Huya Bioscience is using global clinical development to re-evaluate the international potential of an existing molecule. The first model must progress from mechanism and early clinical validation to proof of concept. The second must navigate global registration, commercialization, and an increasingly competitive treatment landscape.
5. Five Takeaways from Shanghai's Innovative Medicine Sector
First, the center of gravity in PD-1 competition is shifting. As the market education around single-agent PD-1 therapy matures, companies are moving toward ADC combinations, VEGF bispecifics, and multi-drug regimens. The next advantage may come from combination design rather than from the checkpoint inhibitor alone.
Second, ADCs and T-cell engagers are becoming major antibody innovation platforms. Programs involving HER2, PD-L1, and DLL3 show that value increasingly depends on the full design of the therapy, including target selection, payload, linker, format, and combination strategy.
Third, CAR-T is expanding beyond blood cancers. Solid-tumor CAR-T and CD19 CAR-T programs in systemic lupus erythematosus are opening new clinical possibilities. The challenge is to demonstrate durable benefit while managing manufacturing complexity, safety, and cost.
Fourth, globalization means more than selling overseas. Multi-regional Phase III trials, FDA and EMA designations, international licensing, and global commercial infrastructure are becoming important measures of a company's platform capability.
Fifth, R&D and commercialization must work together. Between regulatory approval and patient access lie medical education, treatment pathways, payment systems, supply chains, and real-world adoption. The next leaders are likely to be companies that can connect research, registration, manufacturing, commercialization, and international partnerships into one operating system.
6. How CMCS Helps Patients Discuss Innovative Medicines with Specialists
For an international patient considering an innovative medicine in China, the most important question is not simply whether a drug is new. It is whether the treatment is appropriate for the patient's specific diagnosis, biomarker profile, disease stage, previous treatments, overall health, and treatment goals. China Medical Concierge Shanghai (CMCS) helps patients prepare for that discussion with qualified specialists in Shanghai.
CMCS is a health management and medical concierge service, not a hospital and not a substitute for a physician's diagnosis or prescription. Our role is to make the communication process clearer, more complete, and more efficient. Before a consultation, a case manager can help organize medical records, pathology reports, imaging, laboratory results, genetic or biomarker testing, medication history, and previous treatment outcomes. When necessary, the information can be arranged in a concise English-language medical summary for the specialist's review.
CMCS can also help patients prepare focused questions for the consultation. These may include:
- Is the proposed innovative medicine approved for this diagnosis and treatment line in China?
- Does the patient's pathology, biomarker status, or genetic profile support its use?
- Is the treatment a standard approved option, an off-label consideration, or part of a clinical trial?
- What benefit could reasonably be expected, and how would response be monitored?
- What are the important safety risks, contraindications, drug interactions, and monitoring requirements?
- Are there alternative treatments with stronger evidence or a better fit for the patient's condition?
During the specialist consultation, CMCS can assist with appointment coordination, medical interpretation, communication between the patient and the care team, and clarification of the doctor's recommendations. After the consultation, the case manager can help the patient understand the proposed next steps, identify which documents or tests are still needed, and coordinate follow-up communication with the hospital or physician.
The final treatment decision must remain with the patient and the treating medical team. CMCS does not select or prescribe a medicine independently. Instead, it helps the patient bring the right information to the right specialist and make sure that important questions about indication, evidence, risks, monitoring, access, and alternatives are discussed before treatment begins.
Conclusion
From PD-1 to IO+ADC combinations, and from precision small molecules to solid-tumor CAR-T, Shanghai's innovative medicine sector showed clear platform and global-development characteristics across 2025 and 2026. The companies reviewed here are pursuing different technologies, but they are addressing the same fundamental question: how can the success of one product become a repeatable capability in research, clinical development, patient access, and international competition?
For patients, healthcare professionals, and industry observers, understanding these technology strategies can support a more balanced view of where new therapies stand in their development. The suitability of any medicine or cell therapy must be assessed according to the specific indication, approved label, clinical evidence, and advice from qualified physicians. This article is not individualized medical advice.
Source note: This article was prepared from the company and program information provided for editorial use. Approval status, clinical data, and development milestones should be confirmed against official regulatory announcements, company disclosures, and formally published research.
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