Heavy news! Russian local research and development of anti-PD-1 therapy Forteca approved for listing, Shanghai Pharma and BIOCAD joint venture to introduce Greater China!

April 30, 2020 /
Bio-Valley BIOON/ -- Russian BIOCAD Biopharmaceutical sino has announced that the first locally developed PD-1 inhibitor Forteca (INN:prolgolimab) has been approved by the Russian Ministry of Health for the treatment of one of the most invasive cancers: surgically invasive or metastatic melanoma it is worth mentioning that in September 2019, at the invitation of Prime Minister Medvedev of the Russian Federation, Premier Li Keqiang of the State Council paid an official visit to Russia from September 16 to 18 and held the twenty-fourth regular meeting between the Chinese and Russian Prime Ministers On September 17, Zhou Jun, Chairman of the Shanghai Pharmaceutical Group Co., Ltd ("Shanghai Pharma"), signed an agreement with Dmitry Morozov, founder and CEO of the Russian BIOCAD , in St Petersburg, Russia, establish a joint venture SPH-BIOCAD (HK) Limited ("Joint Venture") As BIOCAD's only platform in Greater China, the joint venture will continue to introduce cutting-edge biopharmaceutical products and biotechnologies in the future the project has been listed as a priority project and has received great attention from both governments the registered capital of the joint venture was US$400 million, of which Shanghai Pharma contributed US$200.4 million in cash, accounting for 50.1% of the joint venture's equity, AND BIOCAD contributed US$29.94 million in cash and six biopharmaceutical products in Greater China (including mainland China, Hong Kong, Macao and Taiwan) for permanent and exclusive research and development, production, sales and other commercialrights, accounting for 49.9% of the joint venture's equity it is understood that the first six biopharmaceutical products cooperation include three biosimilars and three innovative biopharmaceuticals three biosimilars, including anti-tumor drugs and rheumatoid arthritis drugs, have been marketed in Russia, and two of them have been approved for sale in countries outside Russia The three innovative biologics are an IL-17 antibody product for psoriasis and strong syllanitis, a PD-1 antibody product and a GITR antibody product, the first of which was launched in Russia in 2019, and the 2nd , forteca, was recently approved in addition to the first batch of 6 products, the two sides agreed to joint venture as the only platform in Greater China, relying on their respective resource advantages in product research and development, registration application, lean production and marketing, and other areas of research and development innovation projects in the field of cell therapy, vaccines and other areas to launch a comprehensive strategic cooperation, continuous development and expansion of bio-innovative product pipelines approval of Forteca by the Russian Ministry of Health is based on positive clinical results from a multicenter, open label, parallel group PHASE II study of MIRACULUM (NCT03269565) conducted in patients with advanced melanoma During the study period, patients were treated with prolgolimab monobly at a dose of 1 mg/kg per 2 weeks or 3 mg/kg every 3 weeks until the condition worsened or intolerable toxicity developed results showed that in patients with advanced melanoma , two drug regimens of prolgolimab monotherapy showed significant anti-
tumor activity and controlled safety In 42 of the 126 patients, the condition was objectively alleviated, and the , i.e objective remission rate (ORR), was 33.3% 1mg/kg group every 2 weeks, 3 mg/kg per week group 12 months survival rate of 74.6%, 54.0% The incidence of treatment-related adverse events (TRAE) was 55.6% and 54.0% respectively in the groups, and the incidence of 1mg/kg in the 1mg/kg group of the 3-4 stat, and 3.2% in the 3mg/kg group, respectively melanoma is a skin cancer developed by melanin cells, the pigment cells that produce melanin Skin melanoma is the 19th most common cancer in the world, with nearly 300,000 new cases each year, according to Global Cancer Watch The number of cases of melanoma in Russia is reported to be 10,930, with 4,010 deaths a year, and diagnosis the of melanoma is often delayed, with 19% of patients suffering from advanced or metastatic diseases at the time of treatment, resulting in poor prognosis and low survival rates Forteca's active pharmaceutical ingredient is prolgolimab, the first IgG1 anti-PD-1 monoclonal antibody with a Fc silent "LALA" mutation PD-1 inhibitors are the mechanism of action to restore T lymphocytes' ability to recognize and kill malignant cells, so that the immune system can resume fighting tumors again Immunotherapy is one of the most promising fields of medicine in the world Clinical studies of more than 3,000 immunocheckpoint inhibitors are being conducted in more than 20 tumor The global immunotherapy drug market is worth $22 billion in 2019 in Russia and Europe, prolgolimab is also investigating other types of cancer BIOCAD has recruited patients for the European Phase II clinical study of advanced non-small cell lung cancer (NSCLC) and has obtained multiple mandates throughout Europe for stage III studies of advanced cervical cancer Dmitry Morozov, chief executive of BIOCAD, said: "We are pleased that BIOCAD offers a new option for patients with who cannot be surgically or metastatic
melanoma Progolimab is structurally a unique drug: it is the first PD-1 inhibitor based on IgG1 monoclonal antibodies and additional modification swastoined to the properties of the effector In Russia, the registration approval of the first locally developed PD-1 inhibitor marks an important stage in the development of immuno-oncology and the treatment of patients with malignant (biovalleybioon.com) original source: Novel anti-PD-1 drug wa app roved for melanoma