March 21, 2026, Beijing, China — Grand Life Sciences Group Co., Ltd. (hereinafter referred to as "Grand Life Sciences") and Belief BioMed Inc. (hereinafter referred to as "Belief BioMed") officially signed an exclusive commercialization cooperation agreement in Beijing. Under the agreement, Grand Life Sciences secured exclusive commercialization rights in the Chinese mainland, Hong Kong, Macau, and Taiwan regions of China for Belief BioMed's investigational product BBM-H803 Injection, a gene therapy for hemophilia A.

As the strategic core platform of Grand Life Sciences in the field of blood products and scarce resources, Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as "Grand Shuyang") will lead the subsequent commercialization and implementation of the product. This marks a milestone transition for Grand Shuyang in hemophilia care — moving from "blood supplementation" to a "gene-based cure".

▲ Signing Ceremony for Commercialization Cooperation between Grand Life Sciences and Belief BioMed

Dr. Xiao Xiao

Co-founder, Chairman, and Chief Scientist of Belief BioMed

Dr. Xiao Xiao, Co-founder, Chairman, and Chief Scientist of Belief BioMed, said, "Belief BioMed is dedicated to advancing cutting-edge gene therapies. Our pipeline spans both rare and common diseases, and we are committed to addressing unmet clinical needs. In 2025, we successfully launched China's first gene therapy for hemophilia B, Xinjiuning^®, providing Chinese hemophilia B patients with a new treatment option ^[1]. Today, in the field of hemophilia A treatment, we are pleased to have formed this strategic partnership with Grand Life Sciences, combining Belief BioMed's solid clinical development strength with Grand Life Sciences' strong commercialization capabilities — a complementary match to jointly advance the commercialization of gene therapies for hemophilia A. We look forward to soon bringing a new treatment regimen to Chinese patients with hemophilia A."

Mr. Feng Zenghui

Chairman of Grand Life Sciences Group and Grand Shuyang

Mr. Feng Zenghui, Chairman of Grand Life Sciences Group and Grand Shuyang, said, "Relying on the blood-product resources of our subsidiary Grand Shuyang, Grand Life Sciences has been deeply committed to advancing treatments for hematologic diseases. This collaboration with Belief BioMed in hemophilia A is a key initiative in building our innovative hemophilia pipeline. By combining Belief BioMed's cutting-edge R&D with Grand Life Sciences' established commercialization platform and market channels, we aim to efficiently improve access to this innovative therapy in China so that more patients with hemophilia A can benefit as soon as possible and be freed from the pain caused by frequent injections and bleeding."

Hemophilia A is an inherited coagulation disorder caused by a deficiency of coagulation factor VIII (FVIII) in the patient's blood. It is characterized by recurrent, spontaneous bleeding into joints, muscles, and soft tissues; repeated hemarthrosis can cause progressive joint damage, impaired mobility, and eventual disability. In China, hemophilia prevalence is estimated at 2.73–3.09 cases per 100,000 population, with more than 30,000 registered patients with hemophilia A. Currently, most patients receive FVIII replacement therapy, which carries infection risks and requires frequent injections; substantial unmet medical needs therefore remain ^[2].

BBM-H803 Injection is an adeno-associated virus (AAV)-based gene therapy for hemophilia A with proprietary intellectual property owned by Belief BioMed. A single intravenous dose delivers an optimized FVIII gene to patients with hemophilia A, aiming to raise and durably maintain FVIII levels and provide sustained protection against bleeding for patients. BBM-H803 Injection's design features a capsid from a liver-tropic AAV serotype and an optimized, high-efficiency gene expression cassette. Its production uses the Company's proprietary serum-free suspension culture process and complies with Good Manufacturing Practice (GMP) requirements ^[3].

In 2022, an investigator-initiated trial (IIT) of BBM-H803 Injection (NCT05454774) was launched. In December of the same year, the Food and Drug Administration (FDA) granted orphan drug designation (ODD). In July 2023, the National Medical Products Administration (NMPA) approved the investigational new drug (IND) application for BBM-H803 Injection. In October 2024, the FDA granted Rare Pediatric Disease Designation (RPDD).

This cooperation, based on solid mutual trust and efficient collaboration between the two parties, will accelerate Belief BioMed's commercialization of its hemophilia A gene therapy product in China, kindle hope for more patients, and inject new momentum into the robust growth of China's gene therapy industry.

参考文献

References

[1] https://www.beliefbiomed.com/newsd-825.html

[2] Feng Xue, et al，Report on the diagnosis and treatment of hemophilia in China (Version 2024)，LabMedDiscovery1(2024)100007, https://doi.org/10.1016/j.lmd.2024.100007

[3] https://www.beliefbiomed.com/newsd-745.html  

About Belief BioMed

Belief BioMed Inc. is a global high-tech enterprise integrating R&D, manufacturing, and clinical application of gene-therapy products. The Company is committed to providing more effective, innovative gene therapies for serious genetic and chronic diseases using safe and efficient viral-vector technologies. It has developed hundreds of key vector technologies, including a HEK293 suspension, serum-free culture process, and a comprehensive chromatography-based large-scale purification process, and has established a commercial manufacturing platform for gene-therapy products. The Company has made comprehensive arrangements in fields of novel AAV capsids targeting different tissues, high-efficiency transgene expression cassette design, and advanced clinical-grade vector manufacturing processes. In addition, it has also established a rich R&D pipeline, with therapeutic areas covering diseases with unmet clinical needs such as hemophilia, Duchenne muscular dystrophy, Parkinson's disease, and osteoarthritis; multiple product pipelines have already entered the clinical study stage or IND application stage, and its new gene therapy drug for hemophilia B has been approved for marketing by the National Medical Products Administration.

About Grand Life Sciences

Grand Life Sciences Group Co., Ltd. is registered in the Changping District, Beijing. It is an international pharmaceutical and healthcare enterprise group, driven by innovation and underpinned by a solid industrial foundation. Over the years, Grand Life Sciences has established an industrial layout that encompasses five key areas: blood products, probiotics, vaccines, medical nutrition, and perioperative care. Grand Life Sciences is committed to the development philosophy of "independent innovative R&D + external precise introduction". It focuses on cutting-edge technologies in global new drug R&D, strategically planning distinctive product matrices and differentiated product pipelines that cover the entire R&D lifecycle based on clinical value. The Company maintains an industry-leading position in areas such as blood products, live biotherapeutic products, perioperative hemostasis, and vaccines, and currently possesses over 30 core innovative product pipelines. It has established five R&D centers in Beijing, Chengdu, Nanjing, Wuhan, and Hangzhou, and over 30 product candidates are currently in clinical development, consistently providing new momentum for its innovation. Grand Life Sciences has established production bases featuring high-standard construction and advanced quality management across nearly ten cities in China. Its sales network spans all provinces and cities, reaching hundreds of thousands of points of sale. Blood products are widely sold globally, exported to over 20 countries, and the Company continuously accelerates the expansion of overseas markets. Committed to the mission of "serving the people wholeheartedly", Grand Life Sciences consistently adheres to the business purpose of "patient and customer-centered, research-driven, and market-oriented". Guided by the principle "One Dose, Two Lives", it earnestly fulfills the social responsibility to build a globally innovative enterprise in life sciences.

About Grand Shuyang

Grand Shuyang, a wholly-owned subsidiary of Grand Life Sciences Group Co., Ltd., traces its origins to the Plasma Research Institute of the Chengdu Military Region Logistics Department, established in 1969. In 1985, the Chengdu Shuyang Pharmaceutical Factory was officially founded, becoming one of the first blood product manufacturers approved by the Ministry of Health of the People's Republic of China for industrial production. In 1998, the factory was transferred from the Chengdu Military Region Logistics Department to the Chengdu Municipal Government and joined China Grand Enterprises, Inc. in 2001. Over the past half-century, Grand Shuyang has continuously innovated and advanced, solidifying its position as a leading high-tech enterprise in China's blood products industry.

Grand Shuyang has developed a comprehensive R&D capability platform, evolving from blood source management to recombinant technology. Its product portfolio encompasses three major categories: albumin, immunoglobulins, and coagulation factors, making it an enterprise in China's blood products industry with a high plasma utilization rate, a comprehensive product range, and extensive specifications. Grand Shuyang has established a globally leading Industry 4.0 intelligent manufacturing base for blood products, enabling full coverage of market demands across the entire product chain and positioning itself as a world-class industrial base for blood products. The Company has secured exclusive commercial rights in China for the global innovative hemophilia treatment, Tissue Factor Pathway Inhibitor (TFPI) monoclonal antibody KN057, which has initiated two Phase III clinical trials in China and received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in 2024.

Moving forward, Grand Shuyang will adhere to a development path of "high-quality standards, comprehensive product coverage, and market internationalization". It aims to consolidate the driving forces for industry advancement and harness synergy for rapid growth, striving to become a "full-product-chain international premium service provider in the blood products sector" to safeguard human health, enhance the quality of life, and co-create a better future.

声明

Statement

This article pertains only to the day's events and information, and is not intended to promote any company's products and/or services, nor should it be understood as providing any opinions or suggestions on the selection of any drugs and treatment regimens.

For any information about the Company's products, medical conditions, and/or treatments, please consult healthcare professionals.

The BBM-H803 Injection described herein has not been approved for marketing.