Jiaxing Startup Secures Approval for Clinical Trials of Diabetes Islet Cell Injection Aiming for Functional Cure

By Shen Huanpin | Jiaxing Daily

A Jiaxing-based biotech startup has secured regulatory approval to begin clinical trials for an islet cell injection therapy — a potential functional cure for diabetes that could challenge the dominance of Western-developed drugs in the field.

Dr. Yang Zijiang spent six years building what he calls a distinctly Chinese answer to one of medicine's most expensive problems. At his company's pilot production base in Jiaxing, a city in eastern China's Zhejiang Province, his team of more than 40 scientists and engineers has developed an artificial islet cell therapy designed to replace the damaged insulin-producing cells that define diabetes.

Now, China's National Medical Products Administration has given the green light. The drug, called BCP601 Islet Cell Injection, was approved for clinical trials — a milestone that positions it as the first domestically developed therapy of its kind in China, and only the second globally to use natural pluripotent stem cells as its source material.

A Shot at a Functional Cure

For the millions of diabetes patients who depend on daily insulin injections, the promise is transformative. BCP601 aims to deliver a one-time infusion of lab-grown islet cells that function identically to their natural counterparts. The goal: repair the body's insulin-producing capability and eliminate the disease's complications in a single treatment.

"For diabetes patients abroad, comparable drugs are often priced at over 1 million RMB," Dr. Yang said from the company's pilot base, which opened in 2023. "We want to develop future cell and gene drugs that Chinese patients can both use and afford."

The economics matter. Diabetes affects a vast patient population in China, and the lifetime cost of insulin therapy — to say nothing of treating complications like kidney failure, blindness, and neuropathy — can be crushing. Dr. Yang's team has invested heavily in manufacturing process innovations specifically to drive down production costs, betting that affordability will be as critical as efficacy in winning market share.

Breaking the Western Monopoly

Until now, the leading clinical-stage islet cell therapies have been developed using European and American human-derived cells — drugs designed for, and available to, Western patients. BCP601 changes that equation. It is built from Chinese human-derived natural pluripotent stem cells, developed in collaboration with the National Stem Cell Resource Bank, using what the company describes as globally leading mass-production techniques.

"The approval of BCP601 gives China its own source and system of drugs in this track," Dr. Yang said.

The drug is part of China's "15th Five-Year Plan" key industrial focus on cell and gene therapy — a signal of Beijing's strategic intent to build domestic capability in advanced biomedicine. According to the industry publication "Stem Cell Researchers," BCP601 represents a domestic first and a global second in the diabetes space for natural pluripotent stem cell-derived drugs.

From Lab to Clinic

Shengtai Inno (Jiaxing) Medical Technology Co., Ltd. settled in Jiaxing National High-tech Zone in 2019. Today, the company employs more than 40 people, including over 20 with master's or doctoral degrees, and holds dozens of domestic invention patents. It has earned recognition as a National High-tech Enterprise, a Zhejiang Province "Specialized, Refined, Differential, and Innovative" Enterprise, and a National Overseas Returnee Entrepreneurship Start-up Support Program Enterprise.

The company has also partnered with Tsinghua Pearl River Delta Research Institute to build a Pluripotent Stem Cell Drug Engineering R&D Center, and has led multiple national, provincial, and municipal research projects and standards.

Clinical trials for BCP601 are expected to begin soon in Zhejiang Province — the first step toward turning a six-year research effort into a treatment that could redefine how diabetes is managed, not just in China, but potentially worldwide.

Source: Jiaxing Daily | Reporter: Shen Huanpin