DONGGUAN, CHINA- EQS Newswire - 18 October 2019 - GreatBay Bio, a leading AI biotechnology company dedicated to big data-driven CMC(Chemistry Manufacturing and Controls) development of innovative biologics, ispleased to announce that a strategic cooperation was reached with Guangzhou Boji Medical BiotechnologicalCo., Ltd. (hereinafter referred to as "Boji Medical ") to jointly develop GBB101, a new long-acting injectablebiologics for the treatment of anemia caused by Chronic Kidney Disease (CKD). Anew joint venture company has been created to share the R&D achievements ofthe project, including intellectual property rights and any rights andinterests arising in the R&D process. Both companies will inject capitalinto the JV. Since Boji Medical isone of the leading enterprises in the field of clinical and pharmaceuticalresearch and development services in China, they will be responsible to run theclinical phase I study. The cooperation will not only share the risk and returnof the project, but will also be a solid foundation for both companies to havefurther collaboration.

GBB101 isexpected to be one of the first long-acting anti-anemia products launched by adomestic company in China. The trial will be carried out in many 3A hospitals acrossmainland China, where many top experts has been engaged to fully verify theclinical efficacy, safety and pharmacokinetics of the product.

On thiscooperation, Dr. Michael Chen, CEO and Co-founderof Great Bay Bio, said: "It is very exciting to start this cooperationwith Boji Medical. The addition of Boji Medical as a partner will lay a solidfoundation for future clinical trials. I believe this business model isextremely valuable for the product, as it significantly reduces the potentialfor conflict-of-interest, and ensures that our partner is fully aligned indelivering the best quality results for the clinical trial." Dr. Wang jianhua, the Vice President andChief Operation Officer of Boji Medical (also was the 1^stPresident of Australian Chinese Medical Exchange Society, New Drug DevelopmentExecutive Director in WuXi AppTec), said: "Great Bay Bio R&D capability isleading and would bring massive value in the future. It is exciting to haveclose collaboration thereafter."

About GBB101

GBB101 is a long-actingbiologics. It is mainly used to help patients with anemia caused by renaldysfunction to improve the symptoms of anemia. Some patients with hematologicaldiseases, such as myelodysplastic syndrome, and some patients with cancer, alsoneed to be supplemented with related drug. According to relevant data, the prevalenceof CKD in China has been increasing significantly in recent years, the numberof CKD patients in China has reached 130 million, of which renal anemia is themost common complication of chronic kidney disease patients. At present, similarproducts sold in the Chinese market belong to the ordinary category, and thereare no long-acting products on the market. Having GBB101 in the market wouldmeet clinical needs of above issues. Wu Xuebin, chief physician of HematologyDepartment of Beijing Shijitan Hospital, explained that the half-life of ordinaryproducts subcutaneously is about 3-4 hours. Therefore, in order to ensure thetherapeutic effect, patients need to inject three times a week. The half-lifeof long-acting GBB101 is 3-4 times that of ordinary products. Patients need toinject only once weekly/biweekly, significantly improving the convenience andcompliance of the patient.

Brief Introduction of Boji Medical

CRO providingone-stop service for new drug & medical device

Guangzhou BojiMedical Biotechnological Co., Ltd. (hereinafterreferred to as "Boji Medical ",SHE: 300404) was founded in 2002, and was listed on the ChiNext in 2015. BojiMedical is a high-tech innovation company (CRO+CDMO) providing one-stopdevelopment and production service for drug, medical device and healthcareproduct for local and foreign companies. The company has nearly 700 mediumlevel and high-end medical research talents with rich experience, has ninewholly-owned subsidiaries with different business expertise and more than tenholding and shareholding companies.

About Great Bay Bio

Headquartered inHong 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 nationallevel CMC platform. The CMC/CDMO platform has independent and integratedtechnology platforms for drug R&D and large scale preparation. The companyhas a strong existing track record of developing customized CMC packages forbiologic products, some of which are national class I projects of innovativebiological new drugs that have already reached NDA stage.

Great Bay Biois leveraging on its established platform to develop a new vertical in CMC.Specifically, Great Bay Bio strives to utilize AI and other cutting-edgetechnologies to shorten CMC development timelines, lower cost, and increaseefficiency of CMC. With such a platform, it could expand and acquire newcustomer base, and brings fundamental changes to drug development, andultimately benefiting society and patients.

The platformhas been recognized and certificated as "Patent Fostering Enterprise","Patent Pilot Enterprise", "National High-tech Enterprise","Dongguan New R&D Institution", "Guangdong Top TenForeign-funded R&D Center" and "Guangdong GeneticallyPharmaceutical Engineering Research Center". Since 2006, it has undertakena number of government projects and obtained crucial breakthroughs in key areasof Guangdong and Hong Kong. More than 20 million yuan have been received fromthe government to support numerous provincial and national projects, such as"National Major New Drug Innovation"

The CMCplatform encompasses an area of over 3100 square meter, and has a whole set ofadvanced biopharmaceutical research and development hardware, with keyequipment from world-class brands such as Sartorius, Bio-Rad, GE Healthcare,and Waters. The pilot workshop is designed strictly in accordance with cGMPrequirements, with cleanroom standards of C-level and partial A-level.