Pudong Biopharma Firms Intensify Efforts to Better Meet Patient Needs with Innovative Therapies

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(Source: Shanghai Observer)

From the approval of new indications for drugs to the new progress in clinical research, the achievements of Pudong's biopharmaceutical companies continue to emerge. Recently, HUTCHMED's Class 1 new drug, Solpeperib tablets, is proposed to be included in the priority review; Hansoh Pharma’s fifth indication of Almonertinib, "targeted combination," has been approved for marketing; and ImmuneOnco Biopharmaceuticals announced a breakthrough in the development of its novel cell therapy product at an international symposium.

As the main承载区 for the development of Shanghai's biopharmaceuticals industry, Pudong continues to gather力量 and resources from all parties to build a science and technology innovation ecosystem that covers the entire chain from basic research, incubation and acceleration, clinical transformation, to industrialization. It supports companies in increasing their R&D efforts, enhancing their original innovation capabilities, and打通关键节点 from basic R&D to clinical application, allowing the "seeds" of new drug R&D to take root, blossom, and bear fruit quickly within a well-established industrial ecosystem.

Multiple Innovative Drugs Launch New Indications

The website of the Center for Drug Evaluation of the National Medical Products Administration shows that HUTCHMED's Solecuparib tablets are proposed to be included in the priority review, with the indication for adult patients with primary chronic immune thrombocytopenia (ITP) who have been previously treated with first-line standard therapies (glucocorticoids, immunoglobulins) but were ineffective or relapsed.

Solepinib is a novel, selective spleen tyrosine kinase (syk) inhibitor. Syk, as a key protein in the B-cell receptor and Fc receptor signaling pathways, is a well-established therapeutic target for various subtypes of B-cell lymphoma and autoimmune diseases. The Ib/II phase study confirmed that solepinib has good safety and efficacy in treating patients with primary ITP, which was further validated in a double-blind, phase III ESLIM-01 study (NCT05029635). The ESLIM-01 study aims to evaluate the efficacy and safety of long-term treatment with solepinib in adult patients with chronic primary ITP.

In addition to immune thrombocytopenia, HUTCHMED is also exploring the efficacy of Solumepinib for treating warm antibody autoimmune hemolytic anemia and indolent non-Hodgkin lymphoma among other indications. Not long ago, HUTCHMED announced positive topline results from the Phase III registration stage of the ESLIM-02 study, which evaluated Solumepinib in adult patients with warm antibody autoimmune hemolytic anemia. The study met its primary endpoint of durable hemoglobin (Hb) response during weeks 5 to 24 of treatment.

In addition, Hansoh Pharma's Ameile (Aumetinib Mesylate Tablets) has been approved for its fifth indication, in combination with pemetrexed and platinum-based chemotherapy drugs for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This approval marks that Ameile has achieved full-course treatment coverage for EGFR-mutated NSCLC patients from early to advanced stages.

As China's first domestically developed third-generation EGFR-TKI, Almonertinib (brand name: 阿美乐) has expanded from a single indication to five since its initial approval for marketing in March 2020. The previously approved four indications have all been included in the National Medical Insurance Catalog, allowing more lung cancer patients to benefit from innovative Chinese solutions.

CAR-T Cell Therapy Products Witness New Progress

Recently, Yimucheng Bio, a Pudong-based innovative drug company, presented the latest Phase I/IIa clinical research data of its self-developed CLDN18.2-targeted nanobody (VHH) CAR-T cell therapy product IMC002 in patients with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026).

IMC002 is a novel CAR-T cell therapy product targeting CLDN18.2, designed with a highly specific nanobody (VHH) domain to enhance safety and efficacy in the treatment of solid tumors. A total of 16 patients received a single infusion of IMC002 and were all included in the safety analysis, with 15 evaluable for efficacy. Study results demonstrated that IMC002 exhibited excellent safety profiles and encouraging anti-tumor activity in this population.

Professor Xu Jianming, a participant in this study, stated: "imc002 has demonstrated controllable safety and significant anti-tumor activity in patients with advanced gastric/GEJ cancer, and still achieved remission in patients who failed multiple lines of treatment. Notably, one patient achieved complete remission for over a year, which is clinically very meaningful. The study results provide important clinical evidence for the application of CLDN18.2-targeted CAR-T technology in solid tumors, and its excellent safety profile also offers the possibility for exploring earlier-line and long-term beneficial treatment strategies in the future."

According to reports, based on the results of this study, ImmunoCell Bio has initiated a Phase III randomized controlled clinical trial of imc002 in patients with advanced GC/GEJ to further verify its efficacy and safety. This data release marks ImmunoCell Bio's continued progress in the field of CAR-T for solid tumors, particularly for indications with high unmet clinical needs such as gastric cancer, providing new hope for patients with advanced gastric/GEJ cancer.

The reporter learned that, starting from the pain points of solid tumor treatment and clinical benefits, ImmunoFrontier has proposed the clinical strategy of "transforming solid tumors into hematological tumors" for the first time globally. Based on this, it has developed multiple technical platforms such as Peri Cruiser, aiming to enhance the safety of CAR-T products, combat tumor heterogeneity, and improve their expansion and tumor infiltration capabilities.

Author of Shangguan Channel: Pudong Observation