DONGGUAN, CHINA – EQS Newswire – 18 October 2019 – Great Bay Bio, a leading AI biotechnology company dedicated to big data-driven CMC (Chemistry Manufacturing and Controls) development of innovative biologics, is pleased to announce that a strategic cooperation was reached with Guangzhou Boji Medical Biotechnological Co., Ltd. (hereinafter referred to as “Boji Medical “) to jointly develop GBB101, a new long-acting injectable biologics for the treatment of anemia caused by Chronic Kidney Disease (CKD). A new joint venture company has been created to share the R&D achievements of the project, including intellectual property rights and any rights and interests arising in the R&D process. Both companies will inject capital into the JV. Since Boji Medical is one of the leading enterprises in the field of clinical and pharmaceutical research and development services in China, they will be responsible to run the clinical phase I study. The cooperation will not only share the risk and return of the project, but will also be a solid foundation for both companies to have further collaboration.
GBB101 is expected to be one of the first long-acting anti-anemia products launched by a domestic company in China. The trial will be carried out in many 3A hospitals across mainland China, where many top experts has been engaged to fully verify the clinical efficacy, safety and pharmacokinetics of the product.
On this cooperation, Dr. Michael Chen, CEO and Co-founder of Great Bay Bio, said: “It is very exciting to start this cooperation with Boji Medical. The addition of Boji Medical as a partner will lay a solid foundation for future clinical trials. I believe this business model is extremely valuable for the product, as it significantly reduces the potential for conflict-of-interest, and ensures that our partner is fully aligned in delivering the best quality results for the clinical trial.” Dr. Wang jianhua, the Vice President and Chief Operation Officer of Boji Medical (also was the 1st President of Australian Chinese Medical Exchange Society, New Drug Development Executive Director in WuXi AppTec), said: “Great Bay Bio R&D capability is leading and would bring massive value in the future. It is exciting to have close collaboration thereafter.”
GBB101 is a long-acting biologics. It is mainly used to help patients with anemia caused by renal dysfunction to improve the symptoms of anemia. Some patients with hematological diseases, such as myelodysplastic syndrome, and some patients with cancer, also need to be supplemented with related drug. According to relevant data, the prevalence of CKD in China has been increasing significantly in recent years, the number of CKD patients in China has reached 130 million, of which renal anemia is the most common complication of chronic kidney disease patients. At present, similar products sold in the Chinese market belong to the ordinary category, and there are no long-acting products on the market. Having GBB101 in the market would meet clinical needs of above issues. Wu Xuebin, chief physician of Hematology Department of Beijing Shijitan Hospital, explained that the half-life of ordinary products subcutaneously is about 3-4 hours. Therefore, in order to ensure the therapeutic effect, patients need to inject three times a week. The half-life of long-acting GBB101 is 3-4 times that of ordinary products. Patients need to inject only once weekly/biweekly, significantly improving the convenience and compliance of the patient.
Brief Introduction of Boji Medical
CRO providing one-stop service for new drug & medical device
Guangzhou Boji Medical Biotechnological Co., Ltd. (hereinafter referred to as “Boji Medical “, SHE: 300404) was founded in 2002, and was listed on the ChiNext in 2015. Boji Medical is a high-tech innovation company (CRO+CDMO) providing one-stop development and production service for drug, medical device and healthcare product for local and foreign companies. The company has nearly 700 medium level and high-end medical research talents with rich experience, has nine wholly-owned subsidiaries with different business expertise and more than ten holding and shareholding companies.
About Great Bay Bio
Headquartered in Hong Kong, the CMC/CDMO platform of Great Bay Bio was established in 2002, where originally more than 100 million yuan was invested to build a national level CMC platform. The CMC/CDMO platform has independent and integrated technology platforms for drug R&D and large scale preparation. The company has a strong existing track record of developing customized CMC packages for biologic products, some of which are national class I projects of innovative biological new drugs that have already reached NDA stage.
Great Bay Bio is leveraging on its established platform to develop a new vertical in CMC. Specifically, Great Bay Bio strives to utilize AI and other cutting-edge technologies to shorten CMC development timelines, lower cost, and increase efficiency of CMC. With such a platform, it could expand and acquire new customer base, and brings fundamental changes to drug development, and ultimately benefiting society and patients.
The platform has been recognized and certificated as “Patent Fostering Enterprise”, “Patent Pilot Enterprise”, “National High-tech Enterprise”, “Dongguan New R&D Institution”, “Guangdong Top Ten Foreign-funded R&D Center” and “Guangdong Genetically Pharmaceutical Engineering Research Center”. Since 2006, it has undertaken a number of government projects and obtained crucial breakthroughs in key areas of Guangdong and Hong Kong. More than 20 million yuan have been received from the government to support numerous provincial and national projects, such as “National Major New Drug Innovation”
The CMC platform encompasses an area of over 3100 square meter, and has a whole set of advanced biopharmaceutical research and development hardware, with key equipment from world-class brands such as Sartorius, Bio-Rad, GE Healthcare, and Waters. The pilot workshop is designed strictly in accordance with cGMP requirements, with cleanroom standards of C-level and partial A-level.
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