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 1^st
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."

About GBB101

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.