Mabwell Bioscience Partners with Binnopharm Group to Market 9MW0113, 9MW0321 and 9MW0311 in Russia and Eurasian Economic Union Countries

SHANGHAI and MOSCOW, Dec. 20, 2022 /PRNewswire/ -- Mabwell Bioscience (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, today announced the company has entered into an licensing agreement with the Russian pharmaceutical company Binnopharm Group, for 9MW0113, 9MW0321 and 9MW0311, its Adalimumab and Denosumab biosimilars, under which Binnopharm Group will have exclusive rights to develop, register, manufacture and market the drugs with a status of local product in Russia and Eurasian Economic Union countries.9MW0113(Junmaikang) is a biosimilar of Humira®, Junmaikang was approved in China for 8 indications: Rheumatoid arthritis, ankylosing spondylitis, Psoriasis, Crohn's disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children, Crohn's disease in children, and has received support from the Major Scientific and Technological Special Project for Significant New Drug Development during the Twelfth Five-year Plan Period. Humira® is a blockbuster drug with more than 15 indications approved and grossed $20 billion in sales in 2021, making it the highest grossing drug in the world during 2021 that was not a COVID-19 vaccine.

9MW0321 is a proposed biosimilar of Xgeva®. Xgeva® was approved for the indications of:

• Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
• Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
• Treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

9MW0311 is a proposed biosimilar of Prolia®. Prolia® was approved for the indications of:

• Treatment of osteoporosis in women who have undergone menopause who have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis;
• Treatment of men who have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis;
• Treatment of osteoporosis that is caused by corticosteroid medications in men and women who will be taking corticosteroid medications for at least 6 months and have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis;
• Treatment of bone loss in men who are being treated for prostate cancer with certain medications that cause bone loss;
• Treatment of bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures.

Mabwell's 9MW0321 and 9MW0311 have been filed for MA approval with the China National Medical Products Administration (NMPA) at the end of 2021. The total sales of originator drug Xgeva® and Prolia® in 2021 exceeded $5.2 billion.

Mabwell intends to bring 9MW0113, 9MW0321 and 9MW0311 for global markets for the benefit of millions of patients around the world, as part of this global strategy Mabwell is partnering with Binnopharm Group which will be responsible for the local clinical studies, registration, promotion, and finally full-scale local production of all three products in Russia and Eurasian Economic Union countries with a target to obtain local product designation.

This strategic partnership will leverage Binnopharm Group's strength as one of the biggest Russian pharmaceutical producers with significant manufacturing, registration, sales and marketing capabilities in Russia and Eurasian Economic Union countries.

Dr. Datao Liu, the co-founder and CEO of Mabwell, said: "Mabwell is pleased to partner with Binnopharm Group to commercialize and localize three of our biosimilars in Russia and Eurasian Economic Union countries, this collaboration represents the approval of our product quality and high standard of clinical data of our products. This strategic partnership is the first to expand Mabwell's presence in Russia and Eurasian Economic Union countries, an important market for biosimilars and innovative drugs."

Mr. Rustem Muratov, CEO and member of the Board of Directors of Binnopharm Group said: "Partnership with Mabwell is an integral part of our strategy to develop further our biotechnology business in Russia and Eurasian Economic Union territories. The goal of this project is not only to bring Mabwell products in Russia and EEU, but also to establish mutual cooperation with such an innovative company as Mabwell. This cooperation also represents an important milestone for Binnopharm Group, and for our patients in Russia and Eurasian Economic Union countries that will ensure the social benefit from an increased access to high-quality affordable medicines."

About Mabwell (Shanghai) Bioscience Co., Ltd.

Mabwell (688062.SH), an innovation-driven biopharmaceutical company, has the whole industrial chain of R&D, manufacturing, and commercialization. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 1 product has been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com.

About Binnopharm Group:

Binnopharm Group was founded through the consolidation of pharmaceutical assets of Sistema PJSFC (LSE: SSA, MOEX: AFKS). Binnopharm Group is a Top 5 Russian Pharmaceutical company (according to AlphaRM) with more than 25 Billion Rubles turnover and Russia's largest producer of generic medicines and the No. 1 manufacturer of products intended for the Commonwealth of Independent States (CIS) markets). In 2020, Binnopharm Group became the first company in the world to manufacture Covid-19 vaccine. The company has 5 states of the arts manufacturing facilities in different Russian regions for the production of chemical and biological medicines. Binnopharm Group manufactures a total of 200+ pharmaceutical products in various dosage forms (from tablets and capsules to ointments, gels, suppositories, infusion solutions, etc.) It has one of the largest portfolios among Russian manufacturers – 450+ registration certificates of drugs. For more information, log on to: https://en.binnopharmgroup.ru.

SOURCE Mabwell