China Healthcare Select

Sichuan Biokin Pharmaceutical Co., Ltd. (688506.SH) announced on August 25, 2026, that its bispecific ADC yizekang® (BL-B01D1/iza-bren) met the primary endpoint in a Phase III interim analysis for HR+/HER2− breast cancer. The independent data monitoring committee confirmed positive PFS results in the BL-B01D1-306 trial, which enrolled patients with unresectable locally advanced, recurrent, or metastatic disease after at least one prior chemotherapy regimen. Yizekang®, the world’s first and only approved bispecific ADC, targets both EGFR and HER3 and is designed to overcome resistance. It is approved in China for nasopharyngeal and esophageal squamous cell carcinomas, with 40+ global trials, including 20 Phase III studies. The new breast cancer indication remains subject to trial completion and regulatory review.

Yiming Angke Biomedical Technology (HKEX: 01541.HK) announced that its subsidiary, Immunecare Biopharmaceuticals, has reached two critical clinical milestones for IMC-003 (IMM72), an ActRIIA-Fc fusion protein targeting pulmonary arterial hypertension (PAH). The first patient has been enrolled and dosed in a Phase Ib/IIa PAH trial. Additionally, enrollment is complete for all dose groups in both the single ascending dose (SAD) and multiple ascending dose (MAD) Phase I studies in postmenopausal healthy women. The Phase I studies have demonstrated a clean safety profile with no dose-limiting toxicities or Grade 3+ adverse events. IMC-003 is engineered to have over five times the binding and signal-blocking activity against Activin A compared to the approved therapy Winrevair (sotatercept), potentially offering a better safety profile. The company expects to report complete Phase I data in 2026 and accelerate into Phase II development.

A landmark phase II study published in the Journal of Clinical Oncology reveals that trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted ADC developed by Hengrui Pharma, demonstrates remarkable efficacy in advanced salivary gland carcinoma. The biomarker-stratified trial achieved a striking 91.7% objective response rate in the HER2-high cohort and a clinically meaningful 45.5% ORR in the HER2-low cohort, alongside favorable safety profiles. These findings challenge traditional HER2 classifications and offer a new therapeutic paradigm for this rare and aggressive malignancy across a broader spectrum of HER2 expression.

Three leading Chinese medical device companies, PINS Medical, SNEURO MEDICAL, and Haifu Medical, have had their respective brain-computer interface (BCI) products—representing invasive, semi-invasive, and non-invasive technologies—selected for China's Innovative Medical Device Special Review Procedure, commonly known as the green channel. This simultaneous approval marks a watershed moment for China's BCI industry, establishing a complete technological ecosystem across all major BCI modalities that challenges Western dominance. Supported by strong national policies, this fast-track regulatory process aims to accelerate the commercialization of these breakthrough neural technologies, democratizing access to advanced neurological therapies and positioning China to lead the global BCI market.

On August 24, China's Center for Drug Evaluation (CDE) announced proposed Breakthrough Therapy designations for two innovative oncology drugs from CSPC Pharmaceutical Group and Qilu Pharmaceutical. CSPC's SYS6010, an EGFR-targeting antibody-drug conjugate (ADC), received the designation for treating relapsed or metastatic head and neck squamous cell carcinoma. Qilu's QLC5508, a B7-H3-targeting ADC with a highly potent SuperTopoi™ payload, was designated for advanced extrapulmonary neuroendocrine carcinoma. Both drugs have already secured Breakthrough Therapy designations for multiple other indications, underscoring their therapeutic potential. These designations are expected to accelerate clinical development and bring innovative cancer therapies to patients more quickly.

Chinese biotech company Huadao Biopharma has filed for regulatory approval of its CAR-T therapy, Wanji'aoluncai injection, with a proposed price of approximately 200,000 yuan (around $27,500 USD) — marking the first time a CAR-T product in China has broken the 300,000-yuan threshold and representing a price cut of over 1 million yuan from existing market prices. The company attributes this dramatic cost reduction to its proprietary fully automated, closed-cell manufacturing platform called the 'Ant Workshop,' which reduces manufacturing costs to approximately one-tenth of imported equivalents while boosting production capacity by more than 50 times and lifting cell production success rates from 80% to 99%. If approved, this breakthrough could transform CAR-T from an unaffordable, bespoke treatment into a scalable therapy accessible to ordinary patients, potentially reshaping the landscape of cancer cell therapy pricing and insurance coverage in China.