China Healthcare Select

To address limited treatment options and tumor heterogeneity in advanced colorectal cancer, Helixon (formerly Huashen Zhiyao) has developed tsTCE3, a novel trispecific T-cell engager simultaneously targeting CEACAM5, CDH17, and CD3. Featuring an optimized 1Fab-plus-2scFv architecture, tsTCE3 demonstrates potent tumor-killing activity and significantly outperforms existing bispecific antibodies in preclinical models, particularly in tumors with low CDH17 expression. By utilizing moderate binding affinities and highly specific antibodies, the molecule achieves robust efficacy while maintaining a favorable safety profile with restrained cytokine release, offering a promising therapeutic strategy for refractory metastatic colorectal cancer.

China Isotope & Radiation Corporation (HKEX: 01763) announced that its subsidiary, Shenzhen Zhonghe Headway Bio-Sci&Tech Co., Ltd., has obtained a drug registration certificate from the National Medical Products Administration (NMPA) for its self-developed 50mg Urea 13C Powder Breath Test Kit, used to diagnose Helicobacter pylori infection. This marks the first generic drug approval of its kind under China's reformed pharmaceutical registration system since 2017. The new 50mg formulation complements the company's existing 75mg product, providing clinicians with greater dosing flexibility. The company is actively pursuing GMP compliance, with the product expected to enter the market by December 2026.

Hainan Haiyao Co., Ltd. (000566.SZ) announced that its wholly owned subsidiary, Haikou Pharmaceutical Factory Co., Ltd., has received a Drug Registration Certificate from China's NMPA for isavuconazonium sulfate for injection. This next-generation broad-spectrum triazole antifungal agent is indicated for the treatment of invasive aspergillosis and invasive mucormycosis. It offers clinical advantages including high bioavailability, predictable pharmacokinetics, and a formulation free of nephrotoxic excipients. Financial details and commercialization timelines were not disclosed.

Viatris Inc. has announced a $1.65 billion cash acquisition of Pacira BioSciences to expand its non-opioid pain management portfolio with established products like EXPAREL and ZILRETTA. In global regulatory developments, China's Jiangsu Hengrui Pharmaceuticals reported that the European Medicines Agency (EMA) has accepted its marketing authorization application for fluzoparib, a PARP inhibitor for metastatic castration-resistant prostate cancer, highlighting its growing ambitions in European markets.

At the 62nd EASD 2026 annual meeting in Milan, Raynovent presented Phase II SHINING-1 results for RAY1225, a biweekly GLP-1/GIP dual agonist. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 243 patients with type 2 diabetes treated for 24 weeks. At 15 mg, RAY1225 reduced HbA1c by 2.76 percentage points to 5.34%, with 100% achieving HbA1c <7% and the composite endpoint of HbA1c <7% plus ≥5% weight loss. Mean weight loss reached 12.87 kg, with improvements in blood pressure, lipid profiles, and liver and kidney function markers. Adverse events were mainly mild-to-moderate gastrointestinal events. Enabled by patented stapled-peptide technology, RAY1225 offers convenient biweekly dosing and is advancing to Phase III trials for diabetes and weight management.

Shanghai-based BRL Medicine announced that its off-the-shelf allogeneic CAR-T therapy BRL-303 (TyU19) has achieved dual regulatory milestones in China: IND approval for relapsed/refractory systemic sclerosis (SSc) on September 10, 2026, and inclusion in the Center for Drug Evaluation's (CDE) 'Care Program-Extension' on October 8, 2026. BRL-303 is the first CAR-T product admitted to this fast-track initiative for breakthrough therapies targeting rare diseases. Targeting CD19 on B cells, the therapy aims to deplete abnormally activated B cells that drive autoimmune destruction. This marks BRL-303's second autoimmune IND following its clearance for systemic lupus erythematosus (SLE). Early clinical results published in Cell demonstrated deep B-cell depletion, significant improvements in skin scores and organ fibrosis indicators, and sustained clinical benefits with no serious adverse events such as CRS, GvHD, or ICANS observed.