SHANGHAI, China I April 20, 2022 I On April 1, Dragon Boat Pharmaceutical announced that its self-developed anti-CLDN18.2 antibody injection (BC008) had obtained the implied approval for clinical trials from China’s National Medical Products Administration, and will be used for the clinical trials in the treatment of CLDN18.2-positive advanced malignant solid tumors.

CLDN18.2 is a member of the CLDN family of proteins, which controls the flow of molecules among cells by building barriers next to cells. Under normal physiological conditions, CLDN18.2 is only specifically expressed on the surface of differentiated epithelial cells of the gastric mucosa. However, after malignant tumorigenesis, tight junctions are destroyed, exposing CLDN18.2 epitopes on the surface of tumor cells, CLDN18.2 is highly expressed on the surface of various tumor cells. The studies show that CLDN18.2 is highly expressed in tumor cells of 50%–80% of gastric cancer patients and 60% of pancreatic cancer patients. This highly expressed in tumor cells but expressed only in the tight junction region of gastric epithelial cells makes CLDN18.2 an ideal target for targeted therapy of gastrointestinal tumors, and attracted extensive attention from the industry. However, no drug targeting CLDN18.2 is available in the global market.

The preclinical study data of BC008 antibody injection shows that the drug can specifically target and bind CLDN18.2 molecules on the cell surface, and can play an anti-tumor role by specifically killing CLDN18.2-positive tumor cells through Fc-mediated immune effector functions such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The in vitro activity study results show that the affinity to CLDN18.2 and ADCC activity of BC008 are significantly stronger than those of the same-target drug IMAB362; the in vivo efficacy assays show that BC008 has a dose-dependent anti-tumor effect on human gastric cancer NUGC-4, human pancreatic cancer BxPC-3, and HEK293T mouse tumor models expressing CLDN18.2. 

Dragon Boat Pharmaceutical is exploring other ways for the development of drugs targeting CLDN18.2. Its candidate drug BC007, a new sequence of CLDN18.2×CD47 dual-antibody drug, has completed pharmacological and non-clinical studies and will start clinical filing this year.

In China, the prevalence and fatality of gastrointestinal tumors are much higher than the global average. As an China-based innovative pharmaceutical company committed to the R&D of biological drugs, Dragon Boat Pharmaceutical focuses on the treatment of gastrointestinal system tumors based on clinical needs. Huang Yingfeng, General Manager of Dragon Boat Pharmaceutical, said that they were looking forward to proving the safety and efficacy of BC008 on tumor patients through rigorous clinical trials, and providing new treatment options for the large number of tumor patients.

Dr. Lang Guojun, CEO of Sanyou Bio, said, “Congratulations to Dragon Boat Pharmaceutical on obtaining the approval for the clinical trial of anti-CLDN18.2 antibody drug BC008! We hope that the rigorous clinical trials will prove the safety and efficacy of BC008! We are honored by contribution in the early research and development of this drug. We will continue making every effort to build the world’s top integrated R&D platform for innovative antibody drugs, and cooperate with partners to jointly break new ground in the diagnosis and treatment of human diseases.

About Dragon Boat Pharmaceutical

Founded in 2005, Dragon Boat Pharmaceutical is a China-based innovative pharmaceutical company committed to the R&D and manufacturing of biological drugs. We focus on the treatment of gastrointestinal cancers and are dedicated to bringing novel drugs for the treatment of oncology and autoimmune disease to global patients. The company was acquired as a wholly-owned subsidiary by Guilin Sanjin (002275) in 2013. Adhering to the concept of independent innovation, we established a 5000-metre-square drug R&D center in Zhangjiang High-tech Park, which covering new drug development, preclinical research, IND, clinical research and manufacturing. Our pipeline consists of 9 biologics candidates, 5 of them have entered the clinical development stage, with rich types of antibodies covering multiple immune targets. Depending on insistent investment in R&D and excellent drug discovery capability, Dragon Boat Pharmaceutical has become a leading innovative biotech company in China.

About Sanyou Biopharmaceuticals

Sanyou Biopharmaceuticals is a leading international High-tech biotechnology company focused on research, development and providing integrated solutions for innovative antibody drug developments.

Sanyou is committed to building world-leading antibody drug discovery and development platforms of high-quality, high-throughput, integrated R&D and value transformation. Sanyou is dedicated in constructing a business ecosystem for therapeutic, R&D and diagnostic products and services, and collaborating with global biopharmaceutical, diagnostic and biotech companies to open a new era for the diagnosis and treatment of human diseases.

Since Sanyou’s founding six years ago, Sanyou has been growing rapidly. As of April 2022, Sanyou has a professional team of more than 250 employees, of which more than 70% hold a PhD or master degree, and this team is deeply experienced in R&D and industrialization of innovative drugs. Sanyou has established an integrated R&D laboratory of ten thousand square meters with advanced facilities in Caohejing Hi-Tech Park in Shanghai. The laboratory has 10 functional modules and more than 40 core technology platforms, led by a series of super-trillion phage display antibody libraries, and followed by a full range of essential R&D platforms for innovative antibody drug discovery, antibody engineering, in vitro and in vivo efficacy screening, pharmaceutical properties analysis, cell line construction and process development. Sanyou continues to provide new technologies, products, services and solutions of “best quality, fastest speed and lowest cost”. Sanyou has established friendly business relationships with more than 300 pharmaceutical companies, biotechnology organizations and diagnostics companies around the world.

“Excellence and innovation, pursuit of dreams, striving and evolving, for the benefit of patients”, holding these principles and beliefs, Sanyou looks forward to working with its clients and partners to build a long-term synergistic growth ecosystem and a healthy society.

SOURCE: Sanyou Biopharmaceuticals