First sound pharmaceutical industry to Hong Kong stock exchange listing, 3 key products are expected to be listed in the next two years!

The latest announcement of the Hong Kong Stock Exchange indicates that First Sound Pharmaceuticals has submitted an application for listing in accordance with Section 8.12 of the Listing RulesAccording to the prospectus, part of the fund-raising will be used for the ongoing research and development of selected products in the fields of oncology and central nervous systemIt is reported that the company expects to have three key products approved for listing in China in the next two yearsScreenshot Source: First Sound Pharmaceuticals Prospectus First Sound Pharmaceuticals is a rapidly transformed pharmaceutical company into an innovation-driven pharmaceutical company dedicated to making patients use more effective drugs earlyIn 2000, the First Sound New Drug Research Center was establishedIn 2003, the First Sound Pharmaceutical Research Institute was established, and in 2018, the First Sound Pharmaceutical Innovation Center was establishedThe company focuses on three rapidly growing and unmet treatment areas, including tumors, central nervous system diseases, and autoimmune diseasesAmong the listed products, one of the first anti-vascular targeted drugs is listed in China, one of the innovative drugs Endo (recombinant human endothelial inhibitor injections)The autoimmune disease treatment drug Adesin (Iramod tablets) has been recommended by several guidelines as the main treatment for active rheumatoid arthritisBoth new drugs will be included in the national health insurance drug list from 2017In addition, according to the announcement of the first sound pharmaceutical industry, its existing portfolio of more than 50 products, most of which have entered the national health insurance and the national list of essential drugsThree key products to be listed in the next two years According to the prospectus, from 2020 to 2021, The First Sound Pharmaceuticals is expected to list three key products: Abassup injection, a soluble fusion protein formed by the fusion of human cytotoxic T lymphocyte-related antigen 4 (CTLA-4) in the transcell region and the human IgG1Fc regionIn 2013, BMS reached a strategic cooperation with Shisheng Pharmaceuticals to jointly develop Abassup in ChinaThe drug, which is expected to be available in China in the third quarter of 2020, will provide new treatment options for patients with rheumatoid arthritis in ChinaIdara is a concentrated solution for injection of right sterol, which is an innovative drug with independent intellectual property rights developed by the first sound pharmaceutical industry after 13 years, and is used to treat strokeThe product is expected to be approved in the second half of this year KN035 (envafolimab), a subcutaneous lysis PD-L1 monotorhem In March 2020, First Sound Pharmaceuticals signed a cooperation agreement with Jiangsu Corning Jerry and Beijing Thoughti Pharmaceuticals, which granted The Pharmaceuticals the exclusive right to market and promote KN035 in China for all tumor indications Currently, the product is currently undergoing Phase 2 clinical trials for colorectal cancer and other advanced solid tumors and Phase 3 clinical trials of advanced biliary cancer, and it is expected that new drug applications will be submitted in the second half of 2020 and approved for listing in 2021 The adaptations of the four major therapeutic areas in the research products (i) tumor first sound pharmaceutical industry in the research of tumor disease products mainly focus on solid tumors and hematoplasm, including targeted monoclonal antibodies and a variety of angiogenesis inhibitors, and small molecule drugs targeting tumor-driven genes Specifically: Beval-Zhusing, a cooperative product between Pioneer Pharmaceuticals and Amgen, is a biosimilar drug developed by Amvitin, which is expected to submit an application for registration of imported drugs around 2022; Seifalazumab, a new generation of recombinant recombinant antivascular endothelial growth factor monoclonal antibodies developed with Apexigen, is expected to launch phase 2/3 clinical trials in 2021; The China IND application is expected to be submitted in 2021 (2) Cell Therapy According to the prospectus, The First Sound Pharmaceuticals has now had more than 10 kinds of cell therapy products for tumors in research, of which 3 self-contained CAR-T cell therapy products introduced through cooperative research and development have been approved clinically for new drugs, and 1 is preparing in-KIND IND declaration materials CD19 CAR-T cell therapy, first sound pharmaceutical industry has two products with CD19 target treatment b cell-related non-Hodgkin lymphoma and acute leukemia, is expected to start phase 1 clinical trial in the second half of 2020, and plans to submit a new drug listing application in 2022 In addition, the company will further expand its treatment of other indications such as cell lymphoma BCMA CAR-T Cell Therapy, according to the prospectus, is expected to be the first and worldwide clinical phase of the use of humanized monodomain antibodies in China, the first and fastest-growing cell therapy product for the treatment of complex/refractive multiple myeloma The product is scheduled to launch a phase 1 study in 2020 and is expected to submit a new drug application in 2023 In addition to blood tumors, the company is also developing or co-developing autologous cell therapy products for the treatment of solid tumors, including HPV16/18-positive cervical, glioblastoma and liver cancer In addition, general-purpose allogeneic cell therapy is another main direction of the first acoustic medicine industry, which is in the process of gene editing the preparation of universal CAR-T cell therapy research, and explore the use of other immune T cells such as NKT cells and NK cells with natural killing function to develop all-body cells to treat a variety of solid tumors (iii) The central nervous system disease Y-2 sub-tongue, is a solid formulation composed of two active ingredients, Idalafon and right-turn alcohol, and plays an anti-inflammatory and improves the permeability of the blood-brain barrier through under-the-tongue administration, thus reducing the brain nerve damage caused by acute ischemic stroke (AIS) The product is currently undergoing phase 1 clinical trials in China and the United States and is expected to launch Phase 2 clinical trials in China in 2021 SIM-307, an APQ4 inhibitor that can effectively control cerebral edema, is intended to be used intravenously for the treatment of cerebral edema caused by acute ischemic stroke At present, the product has completed Phase 1 clinical trial in the United States, and is expected to launch phase 1 trial in China in 2021 (4) The autoimmune disease SIM-335, is an innovative small molecule drug designed for the treatment of patients with mild to moderate plaque-like psoriasis The drug has been approved for clinical trials and is currently in the clinical Phase 1 trial preparation stage The Iramod tablet, a small molecular compound with anti-inflammatory and immunomodulatory effects, is currently in the preparatory stage of inChina's IND declaration SIM-295, a small molecule-innovative drug that selectively inhibits uric acid transporter protein (URAT1), developed to treat gout with hyperuremia At present, the product is in Korea to carry out Phase 2b clinical trials, showing good clinical efficacy and safety, in China in the IND declaration preparation stage According to the prospectus, in addition to the above-mentioned products in research, the first sound pharmaceutical industry in three areas, there are a total of more than 30 in the preclinical research stage of innovative drugs in research products We wish the listing of The First Sound Pharmaceuticals on the Hong Kong Stock Exchange a smooth journey and the use of capital to accelerate the development and listing of innovative products, so as to benefit more patients at an early date Source: Medical Mission