Medical Library | Shanghai Biopharmaceutical Industry Series
Shanghai's innovative medicine ecosystem is moving from single-product success toward platform-based development. Companies are combining established commercial products with ADCs, bispecific antibodies, precision small molecules, CAR-T and CAR-NK platforms, global clinical trials, and international licensing.
This Medical Library review examines nine companies with headquarters or core research and development activities in Shanghai. The 2025–2026 milestones provided range from commercial approvals and global Phase III studies to early clinical programs and investigator-led innovation. For a broader overview of the sector, read Shanghai Innovation Medicine Outlook: From PD-1 Commercialization to the Next Generation of Solid-Tumor CAR-T.
1. Junshi Biosciences: Turning the PD-1 Base into IO+ADC and Bispecific Combinations
Leaders: Li Ning, Chief Scientific Officer, and Li Dan, Chief Executive Officer
Core strategy: Toripalimab, immunotherapy combinations, ADCs, and bispecific antibodies.
Junshi Biosciences is using its commercial foundation in toripalimab to develop combination strategies that may extend the value of PD-1 therapy beyond monotherapy. According to the information provided, toripalimab combined with disitamab vedotin for HER2-positive urothelial carcinoma was approved in May 2026 as the product's 13th indication. It was described as the first domestic immunotherapy-plus-ADC combination of its kind.
JS207, a PD-1 × VEGF bispecific antibody, is advancing in Phase II studies across multiple tumor types. The company's strategic shift is clear: use an established checkpoint-inhibitor platform to build the next wave of IO+ADC and bispecific combinations.
Development stage: Commercialization plus Phase II development.
Key question: Can a successful PD-1 franchise become a repeatable combination-therapy platform rather than remain dependent on a single product?
2. Henlius: Globalizing Serplulimab while Building ADC and T-Cell Engager Platforms
Leaders: Wu Yifang, Chairman, and Zhang Wenjie, Chief Executive Officer
Core strategy: Global development of serplulimab, HER2 and PD-L1 ADCs, and T-cell engagers.
Henlius is combining international commercialization with an expanding innovative antibody pipeline. The provided information states that perioperative serplulimab treatment for gastric cancer was approved in June 2026 and that the product had reached more than 40 countries. HLX22 is advancing through a multi-regional Phase III program, while HLX3901, described as a tetravalent T-cell engager, received IND clearance in March 2026.
The company illustrates a model in which biosimilar globalization can provide a commercial foundation for more differentiated antibody formats. The long-term test will be whether international registration and commercial access can be converted into a sustainable innovation engine.
Development stage: Commercialization plus Phase III development and early clinical innovation.
Key question: Can a global commercial network support a differentiated pipeline in ADCs and multispecific antibodies?
3. HUTCHMED: Shanghai's Small-Molecule Globalization Model
Leaders: Simon Su, Chief Executive Officer, and Xu Yaochang, Chief Scientific Officer
Core strategy: Small molecules targeting VEGFR, MET, FGFR, and EZH2.
HUTCHMED has built an international strategy around precision small molecules. According to the information provided, 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's model is important because it shows how a Shanghai-linked company can use small-molecule expertise, global trials, and international regulatory work to create more than one overseas growth curve.
Development stage: Commercialization plus global Phase III development.
Key question: Can savolitinib reproduce the company's first global success and establish a second major international franchise?
4. Zai Lab: License-In Commercialization with a Growing Proprietary Pipeline
Leader: Ying Du, Founder and Chief Executive Officer
Core strategy: License-in commercialization, local development, ADCs, and T-cell engagers.
Zai Lab has developed one of China's most mature license-in and local commercialization models. The provided information states that tisotumab vedotin, a tissue factor ADC, was approved for cervical cancer in June 2026; repotrectinib for NTRK-positive solid tumors was approved in January 2026; and zoci, identified in the source material as a DLL3 ADC program, received orphan-drug designations from the FDA and EMA.
The company's strategic challenge is to use the efficiency of license-in commercialization to support increasingly differentiated proprietary research. DLL3-directed development is a key area to watch because it could give the company a stronger internal platform in addition to its partnered portfolio.
Development stage: Commercialization plus Phase I and Phase III programs.
Key question: Can a successful commercial platform increasingly produce value from internally developed ADC and T-cell engager assets?
5. JW Therapeutics: Extending CD19 CAR-T into New Indications
Leaders: Li Yiping, Chief Executive Officer, and Yang Guoliang, Chief Scientific Officer
Core strategy: Autologous CD19 CAR-T therapy, manufacturing localization, and expansion into autoimmune disease.
JW Therapeutics is built around relma-cel, an autologous CD19 CAR-T product. According to the provided information, the supplemental biologics license application for second-line relapsed or refractory large B-cell lymphoma was accepted for review in May 2025. The company is also exploring systemic lupus erythematosus, with an early-stage study reported to have reached a 100% SRI-4 response rate in October 2025. The product's frozen storage period was extended to 36 months.
For a CAR-T company, commercial maturity depends on more than the first approval. Indication expansion, manufacturing reliability, storage, logistics, patient access, and management of acute and long-term toxicities all influence whether the therapy can reach more patients. Our CAR-T Therapy in Shanghai guide provides additional patient-oriented context.
Development stage: Regulatory review plus early clinical development.
Key question: Can a blood-cancer CAR-T platform become a durable treatment system for both hematologic malignancies and autoimmune disease?
6. CARsgen Therapeutics: Making Solid-Tumor CAR-T a Clinical Product
Leader: Li Zonghai, Founder and Chief Executive Officer
Core strategy: Autologous CAR-T therapies targeting CLDN18.2, GPRC5D, and GPC3.
CARsgen Therapeutics is focused on targets that may support cell therapy beyond blood cancers. The information provided states that CT041, also known as zevor-cel, received NMPA approval on June 22, 2026, for patients with gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of treatment. 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. The clinical significance of CT041 extends beyond a single product: it represents an attempt to bring solid-tumor CAR-T into routine treatment while addressing target heterogeneity, tumor microenvironment, trafficking, and manufacturing complexity.
Patients should confirm the exact approved indication, biomarker requirements, prior-treatment criteria, treatment-center capabilities, expected response, and risks before considering a solid-tumor CAR-T product.
Development stage: Commercialization of the first reported approved solid-tumor CAR-T, with additional early clinical programs.
Key question: Can a first solid-tumor CAR-T approval become a repeatable platform across additional targets and tumor types?
7. Fosun Pharma: Combining Partnership, Commercialization, and Internal Cell-Therapy Research
Leader: Wu Yifang, Chairman
Core strategy: CAR-T through partnerships and internal research, alongside ADC and T-cell engager programs.
Fosun Pharma represents a large-pharma version of the dual-track model. 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.
The strategic advantage of this model is the ability to combine external technology access, manufacturing scale, commercial infrastructure, and internal pipeline development. The next challenge is to demonstrate meaningful clinical differentiation in dual-target CAR-T and autoimmune indications.
Development stage: Commercialization plus Phase I/II development.
Key question: Can a partnership-led cell-therapy franchise and internal innovation platform reinforce each other over the long term?
8. Dizal: From EGFR Exon 20 Insertion Treatment to Global Licensing
Leader: Zhang Xiaolin, Founder and Chief Executive Officer
Core strategy: Precision small molecules, especially EGFR exon 20 insertion inhibition.
Dizal is focused on the EGFR exon 20 insertion mutation and the targeted therapy sunvozertinib. The information provided states that sunvozertinib 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 path illustrates how a China-originated precision medicine asset can move from molecularly defined clinical development to global validation and a major international rights deal. Patients can also read our Lung Cancer Precision Treatment in Shanghai guide for more context on molecularly targeted lung cancer care.
Development stage: Commercialization, regulatory development, and global business development.
Key question: Can a focused molecular strategy produce a globally competitive first-in-class asset and a repeatable international platform?
9. Yingli Pharma and Huya Bioscience: New Targets alongside Global Re-Development
Leaders: Yingli Pharma's leadership was not disclosed in the supplied material; Huya Bioscience is led by Xu Yi, Chief Executive Officer
Core strategy: Pan-KRAS, PARG, and HIPK2 discovery at Yingli Pharma, alongside global re-development of chidamide by Huya Bioscience.
Yingli Pharma is pursuing emerging targets including pan-KRAS, PARG, and HIPK2. The provided information identifies YL-17231 as the first domestic pan-KRAS program to enter a Phase I clinical trial. This is an early-stage strategy that depends on demonstrating clinical proof of concept in a difficult and highly competitive target class.
Huya Bioscience is taking a different route by redeveloping chidamide globally. The HBI-8000 plus nivolumab study in melanoma was reported to have produced positive global Phase III 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, the two companies illustrate two routes to innovation: focused discovery around new biology and global re-evaluation of an existing molecule. One must move from early mechanism to clinical validation; the other must translate a positive global study into registration and access.
Development stage: Early clinical development for Yingli Pharma and global Phase III development for Huya Bioscience.
Key question: Can new-target discovery and global re-development each produce a durable, clinically meaningful product platform?
10. What These Companies Reveal about Shanghai's Biopharma Ecosystem
Across these nine companies, four development models stand out:
- Commercial platforms becoming combination platforms: Junshi Biosciences and Henlius are extending antibody products into ADC and bispecific strategies.
- Global small-molecule development: HUTCHMED and Dizal are using molecular precision and international trials to build overseas value.
- Cell therapy moving beyond the first indication: JW Therapeutics, CARsgen, and Fosun Pharma are expanding CAR-T across blood cancers, solid tumors, and autoimmune disease.
- Discovery and re-development: Yingli Pharma is pursuing new targets while Huya Bioscience is testing a global path for an existing molecule.
For patients, the practical lesson is to separate commercial availability from clinical promise. A product may be approved for one indication but not another, available only at selected centers, or still accessible only through a clinical trial. Biomarker testing, prior treatment, organ function, and the treating team's experience all matter.
11. How CMCS Helps Patients Discuss Innovative Medicines with Specialists
For an international patient considering a new cancer medicine or cell therapy in Shanghai, the most important question is not simply which company has the most advanced platform. It is whether a specific treatment is appropriate for the patient's diagnosis, biomarker profile, treatment history, health status, and goals. China Medical Concierge Shanghai (CMCS) is a health management and medical coordination service that helps patients connect with specialist doctors and hospital resources in Shanghai. CMCS is not a hospital and does not independently diagnose or prescribe treatment.
Before a consultation, CMCS can help organize pathology reports, immunohistochemistry, genomic testing, imaging, operative notes, previous treatment records, medication history, treatment responses, laboratory results, and current symptoms. For overseas patients, the records can be arranged into a concise English medical summary for the specialist.
CMCS can help patients prepare focused questions such as:
- Is the medicine approved for this diagnosis, biomarker, stage, and treatment line?
- Does the patient's molecular or pathology result meet the treatment's eligibility criteria?
- Is the proposed therapy standard care, part of a clinical trial, off-label, or still investigational?
- What clinical evidence supports the treatment, and how does it compare with alternatives?
- For CAR-T or other cell therapies, what manufacturing, monitoring, hospitalization, and toxicity-management requirements apply?
- What are the expected benefits, major risks, cost and access considerations, and follow-up requirements?
During the consultation, CMCS can assist with appointment coordination, medical interpretation, communication between the patient and the care team, and clarification of the doctor's recommendations. Afterward, a case manager can help organize the proposed next steps, identify additional tests or records, clarify the follow-up schedule, and coordinate further communication with the hospital.
The final treatment decision must be made by the patient and the treating medical team. CMCS does not independently select an innovative medicine, cell therapy, or clinical trial. Its role is to help the patient bring complete information to the right specialist and ensure that indication, evidence, risks, alternatives, access, and monitoring are discussed clearly.
To learn more about oncology consultations and treatment coordination in Shanghai, contact CMCS:
Email: contract@medicalsh.com
WhatsApp: Contact CMCS on WhatsApp
Website: medicalsh.com
Conclusion
The companies reviewed here show Shanghai's transition from isolated product development toward platform-based biopharma innovation. PD-1 products are being extended into ADC and bispecific combinations, small molecules are moving through global trials and licensing, CAR-T is expanding into solid tumors and autoimmune disease, and early-stage companies are pursuing new targets and scalable cell-therapy formats.
For patients, the key is to understand the exact development stage and approved indication of the treatment under consideration. This article was prepared from the company and program information provided for editorial use. Approval status, clinical data, development milestones, and access should be confirmed through official regulatory announcements, company disclosures, formally published studies, and the treating medical team. This article is for medical education only and is not individualized medical advice.
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