Zhangjiang Pharma Valley Companies Accelerate From Lab to Global Markets

Jan 12, 2026 19:33 CST Updated 19:33

HUTCHMED

Biopharmaceutical Manufacturer

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Recently, multiple companies in Zhangjiang Pharm Valley have made significant progress in new drug applications, indication expansion, and technology platform breakthroughs. Zhangjiang Pharm Valley continues to drive the efficient transformation of innovative achievements and accelerate product launches and iterations through institutional innovation, service innovation, and ecosystem innovation.

HUTCHMED's Class 1 New Drug Proposed for Priority Review

(Image Source: CDE Official Website)

On January 8, the CDE official website showed,Zhangjiang Pharma Valley Enterprise HUTCHMEDSolecupinib tablets proposed for priority review, indicated 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, 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 aimed to evaluate the efficacy and safety of long-term treatment with solepinib in adult patients with chronic primary ITP. At the 2025 ASH meeting, HUTCHMED reported the final analysis results of this study.

In addition to immune thrombocytopenia, HUTCHMED is also exploring the efficacy of sovipiplanib for treating warm antibody autoimmune hemolytic anemia and indolent non-Hodgkin lymphoma among other indications. On January 7, HUTCHMED announced positive topline results from the Phase III registration stage of the ESLIM-02 study of sovipiplanib for treating adult patients with warm antibody type autoimmune hemolytic anemia, having achieved the primary endpoint of durable hemoglobin (Hb) response during weeks 5 to 24 of treatment.

Hansoh Pharma Ameile^®The Fifth Indication "Targeted Combination" Approved for Marketing

January 8,Zhangjiang Pharm Valley Enterprise Hansoh PharmaAnnouncement: Almonertinib (Ameile)^®(Hansom Pharma's Aumetinib Mesylate Tablets) Fifth Indication Approved for Marketing: 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 Ameile^®Achieved full-course treatment coverage for EGFR-mutated NSCLC patients from early to late stages.

As the first domestically developed third-generation EGFR-TKI in China, Amelie^®Since its first approval for marketing in March 2020, it has expanded from a single indication to five. The previously approved four indications have all been included in the national medical insurance directory, including: adjuvant treatment after surgery for EGFR-mutated NSCLC patients, maintenance treatment after chemoradiotherapy for unresectable locally advanced NSCLC, and first-line and second-line treatments for advanced NSCLC. While providing high-level evidence-based medical proof for the treatment of the Chinese lung cancer population with the original third-generation EGFR-TKI, it also solidified its clinical status, allowing more lung cancer patients to benefit from innovative Chinese solutions.

IMMUNEONCO's Amurefup Alfa (IMM0306) Monotherapy for Primary Membranous Nephropathy IND Accepted

January 7,Zhangjiang Pharma Valley Company, ImmuneOncoAnnounced that the clinical trial application for the company's self-developed Amurelimumab α (IMM0306) as a monotherapy for Primary Membranous Nephropathy (PMN) has been officially accepted by the NMPA. This represents another significant milestone in the layout of IMM0306 within the field of autoimmune kidney diseases, marking the expansion of this innovative drug into a broader range of glomerular disease treatments.

Previously, the clinical trial application (IND) for the subcutaneous injection formulation of Amurefup α (IMM0306S) for the treatment of systemic lupus erythematosus (SLE) was accepted by the NMPA. Compared to intravenous injection, the subcutaneous formulation can significantly improve the convenience of administration, enhance the patient's treatment experience, and provide a better option for long-term disease management. The development of IMM0306S will further enrich the company's product portfolio in the field of autoimmune diseases.

Comprehensive Editor: HUTCHMED,Hansoh Pharma,IMMUNOONC