May 27, 2021, Shanghai and Taizhou - Mabwell (Shanghai) Bioscience Co., Ltd. ("Mabwell") jointly announced with Yangtze River Pharmaceutical Group Co., Ltd. ("Yangtze River Pharmaceutical") that they have reached a strategic cooperation on the rights and interests of two innovative biological drugs in China: Recombinant (Yeast-secreted) Human Serum Albumin- Human Granulocyte Colony-stimulating Factor Fusion Protein for Injection (8MW0511) and Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (9MW1111). According to the agreement, Yangtze River Pharmaceutical will obtain the exclusive production and commercial rights and interests of 8MW0511 and the exclusive development, production and commercial rights and interests of 9MW1111 in the cooperation area in the future, respectively. For the 9MW1111 project, Yangtze River Pharmaceutical will also obtain the exclusive development rights and interests of 9MW1111 in combination with one or more other drugs, and Mabwell will retain all rights and interests in the development of other forms of drugs such as bispecific antibodies, polyclonal antibodies. Both parties will share future commercial benefits within the scope of cooperation.

Mabwell

Yangtze River Pharmaceutical

Dr. Datao Liu, founder and CEO of Mabwell, said: "It is a great pleasure to enter into a strategic cooperation with Yangtze River Pharmaceutical, and thank Yangtze River Pharmaceutical for its trust and affirmation of our innovative biologics, R&D team and technology platform. Long-acting rhG-CSF is a conventional therapy to promote leukopoiesis in tumor patients after chemotherapy, and PD-1 has a bright prospect in the field of tumor therapy. I believe that with the advanced drug development platform of Mabwell and the rich market experience of Yangtze River Pharmaceutical, we can open up a broader market for the two new drugs in this cooperation and provide more treatment options for more patients."

"Mabwell has an excellent team and rich experience in the development of innovative biological drugs, and our cooperation is highly complementary in whole industry chain of biological drugs. We are also setting up our own production base for biological drugs, and I believe that on the basis of successful cooperation on the two biological drugs, there will be deeper and broader cooperation between us in the future, so as to provide more quality products for patients and achieve win-win development. " said Wei Cai, deputy general manager of Yangtze River Pharmaceutical.

About 8MW0511

8MW0511 is Recombinant (Yeast-secreted) Human Serum Albumin-human Granulocyte Colony-stimulating Factor Fusion Protein for Injection independently developed by Jiangsu T-mab Bio-Pharmaceuticals Co., Ltd., a wholly owned subsidiary of Mabwell. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is engineered by human serum albumin fusion technology to increase the half-life of rhG-CSF in human and prolong the dosing cycle, and to slow release of rhG-CSF and continue to promote the development and release of neutrophils, thereby reducing the incidence, duration, and severity of chemotherapy-associated neutropenia. This product belongs to therapeutic biological product Category 1, and the patent for drug molecule and use has been authorized. It's indicated for the prevention and treatment of leukopenia caused by myelosuppression and leukopenia in patients with bone marrow failure. The product is currently in the phase II/III clinical trials.

About 9MW1111

9MW1111 is an innovative recombinant humanized anti-PD-1 monoclonal antibody targeting PD-1 independently developed by Mabwell. By binding to PD-1 on the surface of T cells, 9MW1111 blocks the binding of PD-1 to the ligands PD-L1 and PD-L2, thus eliminating the immunosuppression of PD-1 signal transduction pathway and restoring the immune function of T cells to attack tumor cells. This product belongs to therapeutic biological product Category 1, and the patent for drug molecule and use has been applied. It's indicated for locally advanced or metastatic solid tumors. 9MW111111 obtained Clinical Trial Notification issued by the regulatory authority in February 2020 and is currently in phase I clinical trials.

About Mabwell

Mabwell is an innovative biopharmaceutical company with a whole industry chain. Since its establishment in 2017, it has recruited and set up 9 new biomedical R&D and production enterprises, and attracted a group of high-level, diversified and experienced technical teams. With the project as the core, the company implements the system of division of labor and coordination according to the research and development stage and technical expertise so as to achieve overall management and rapid development. The company has five distinctive technology platforms in line with international standards and a whole industry chain covering target research, molecular discovery, preclinical development, clinical research, commercial production and sales, and is committed to the commercialization of innovative macromolecular drugs such as antibody drugs and recombinant protein drugs. The company now has more than 10 investigational varieties in different R&D stages, and the treatment fields include autoimmunity diseases, tumors, metabolic disorders, ophthalmologic diseases and infections. Of these, 1 variety has been applied for production and 9 varieties are in different stages of clinical study. Mabwell focuses on industrial transformation based on innovation. Its production base, which meets the requirements of Chinese GMP, US cGMP and EU GMP, for antibody and recombinant protein drugs has been put into use in Taizhou, Jiangsu, and the large-scale production base located in Shanghai is under construction. The company completed Series A funding of 1.97 billion RMB in April 2020. Its first variety will be marketed in 2021, and those currently in clinical trials will be marketed successively between 2023 and 2026.

About Yangtze River Pharmaceutical

Founded in 1971, Yangtze River Pharmaceutical Group is a trans-regional large-scale pharmaceutical group with industry-university-research linkage and integration of science, industry and trade. It has more than 20 member companies, distributed in Beijing, Shanghai, Nanjing, Guangzhou, Chengdu, Suzhou, Changzhou, Taizhou., etc. With development of diversified products, the company has more than 300 varieties, and some products are exported to 30 countries or regions such as Asia, Europe and Africa. With focus on pharmaceutical industry, the company adheres to quality first and innovation-driven development and implements the strategy of "Lay equal stress on three kinds of drugs"- traditional Chinese drugs, chemical drugs and biological drugs. The company has four established national R&D platforms and a professional R&D team. A virtuous cycle of echelon output in is formed in the product research and development. Innovative investigational drugs involve many fields such as oncology, neurology, infection and metabolism, of which more than 10 varieties are in different stages of clinical study. During the 14th Five-Year Plan period, Yangtze River Pharmaceutical took biological drugs as an important development direction, and accelerated the layout of the whole industry chain of R&D, production and sales. It has now completed a full-process preclinical biological drug R&D platform, is building a biopharmaceutical industrial park, and is making full efforts to create Longfengtang (a TCM brand). The company commits to introducing more new and good drugs with high quality and efficacy to meet the people's high-quality health needs.