Regulatory press release

Cinclus Pharma’s linaprazan glurate earns China’s National Reimbursement Listing and is set to launch in China in 2026

Cinclus Pharma Holding AB (publ), a late-stage clinical pharmaceutical company developing next-generation treatments for acid-related diseases, today announced that its drug, linaprazan glurate, has been included in China’s 2025 National Reimbursement Drug List (NRDL) for the treatment of gastroesophageal reflux disease (GERD). Inclusion on NRDL enables broad patient access, and the product is now expected to be launched on the Chinese market in 2026 by its licensee and co-developer Jiangsu Sinorda Biomedicine Co. Ltd. (Sinorda) and their Chinese partner HuaDong Medicine Co. Ltd. (HuaDong).

“It is great news and a strong validation that linaprazan glurate has been included in the reimbursement list in China. It is a landmark achievement for Cinclus Pharma that its partner Sinorda succeeded with this and prepares for the first commercial launch of linaprazan glurate globally, a drug designed to address the unmet medical need for patients suffering from severe GERD. Supported by a strong local partner in China, we are highly confident in the upcoming commercial rollout and the sales growth that lies ahead,” says Christer Ahlberg, CEO of Cinclus Pharma.

Cinclus Pharma has previously entered into a license agreement with Sinorda for the development and commercialization of linaprazan glurate in China and other selected countries in Asia. In December 2024, linaprazan glurate was approved by the Chinese drug authority, and the drug has recently been included on the 2025 National Reimbursement Drug List. As a result, the product is expected to be launched on the Chinese market in 2026.

Under the license agreement, Sinorda is responsible for the research, development, registration, production, and supply of linaprazan glurate in China. Cinclus Pharma is entitled to a low double-digit percentage of the milestone payments Sinorda receives from its commercialization partner, as well as royalty revenues based on a low single-digit percentage of net sales in China.

Sinorda recently announced that HuaDong is its commercialization partner for linaprazan glurate in China, following the conclusion of its previous sub-licensing agreement with SPH Sine Pharmaceutical Laboratories Co. Ltd. HuaDong is a major listed Chinese science-based, patient-centered pharmaceutical company with long-standing expertise and significant market presence in the digestive disease therapeutic area in China. The company reported revenue of RMB 41,906 billion in 2024, has more than 10,000 employees and possesses extensive commercial coverage and marketing capabilities.

About Cinclus Pharma

Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com.