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    Home > Medical News > Medical World News > Rongchang Bio submitted IPO application to the Hong Kong Stock Exchange more than ten funds in the research products to help the capital road!

    Rongchang Bio submitted IPO application to the Hong Kong Stock Exchange more than ten funds in the research products to help the capital road!

    • Last Update: 2020-07-24
    • Source: Internet
    • Author: User
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    RemeGen submitted its IPO application on June 29, according to the website of the Hong Kong Stock ExchangeRongchang Bio is committed to the development of biopharmaceuticals for autoimmune, oncology and ophthalmology diseases, the company has not yet been approved for listing to achieve commercialization, this time according to the HKEx listing rules Chapter 18A ipo application, Morgan Stanley, Huatai International, J.PMorgan as its co-sponsorsRongchang Bio has more than 10 drug candidates in its product pipeline, of which Teitasip has submitted a new drug listing application (NDA) for systemic lupus in ChinaFounded in 2008,Rongchang Bio is a biopharmaceutical company entering the commercialization phase, with co-founders, CEO and Chief Scientific Officer DrFang JianminThe company is committed to the discovery, development and commercialization of its first-in-class and best-of-the-kind biologic drugs for the treatment of autoimmune, oncology and ophthalmology diseases that are not met in China and around the worldIn March this year, the company just completed more than $100 million in financing, led by Lilly Asia Fund and Qingchi Capital, with the participation of internationally renowned investment institutions such as Vito Capital,Industrial Investments, Aobo Capital, Hudson Bay Capital and the company's original investorssince its inception, Rongchang Bio has been developing biopharmaceuticals that target new targets, innovative designs and deep potential to meet unmet clinical needs worldwideAfter more than a decade of development, the company has established a fully integrated, end-to-end medical platform and developed a complete product line of more than 10 drug candidatesTwo of the clinical stage candidatedrugs Teitasip (RC18) and disitamab vedotin (RC48) are conducting registered clinical trials of six indications in China and the United States, Rongchang Biology currently has three highly specific core candidate drugs - Titasip (RC18), disitamab vedotin (RC48), RC28 , which are being developed to treat autoimmune diseases, tumors and ophthalmology diseases:Sip is a new type of TACI-Fc fusion protein, targeting B lymphocyte stimulation factor (BLyS) and proliferation-induced ligand (APRIL), which is an important cause of autoimmune diseases associated with systemic lupus lupus and other B lymphocytes, among other B lymphocytesCurrently, Rongchang Bio is developing Teitasip for the treatment of systemic lupus (SLE), rheumatoid arthritis and other autoimmune diseasesAmong them, SLE is the main indication of TeitasipIn the 2b registration study completed in China, Teitasip showed remarkable efficacy and good safety and toleranceBased on the results of this trial, Rongchang Bio submitted to NMPA in October 2019 a conditional application for the listing of a new drug for the treatment of SLE, which has been included in the priority reviewIn addition to SLE, Rongchang Bio is also conducting a late-stage clinical trial of six other B-cell-mediated autoimmune diseases in China: including two registered clinical studies on spectrum diseases of optic neurospinal itis and rheumatoid arthritis; A Phase 2 clinical study of indications that is large in the population of patients such as IgA nephritis (IgA nephritis) and dry syndrome but still lack effective treatment, and two other Phase 2 clinical studies on rare diseases such as multiple sclerosis and severe myocardine, respectivelyin the U.S., Teitasip obtained FDA approval in January 2020 to conduct a U.Sregistered clinical trial for SLE treatment, and was granted fast-track status in April this yearRongchang Bio plans to conduct Phase 3 clinical trials of SLE worldwide in the first half of 2021, including in the United States, Europe and other countriesDisitamab vedotin is an anti-HER2 antibody drug conjugate (ADC) in the late clinical stageRongchang Bio is developing disitamab vedotin to treat common HER2 expression indications that currently lack treatment, including other than breast cancer HER2 expression (IHC 1 plus or above) cancer indications, such as gastric cancer (GC) and urinary path cancer (UC) (currently registered in China clinical trials), as well as HER2 low-expression cancer (IHC 2 plus FISH-or IHC 1) indications, such as 2 low-expression breast cancer in China (currently registered)in clinical studies on gastric and urinary skin cancers, disitamab vedotin has shown excellent anti-tumor activity and good tolerance: as of June 22, 2020, 127 WHO have undergone second-line chemotherapy treatment in a phase 2 registered clinical trial for gastric cancer (IHC 2) For GC or GEJ cancer patients, disitamab vedotin has an objective mitigation rate (ORR) of 24.4% (confirmed by an independent review board (IRC) assessment, a median progression-free survival (PFS) of 4.1 months, and a total lifetime (Average OS) of 7.6 monthsIn the initial phase 2 clinical study of 43 PATIENTs with HER2 overexpression (IHC 2 plus or IHC 3 plus), the best ORR for disitamab vedotin was 60.5%, with an ORR of 51.2% and a median PFS of 6.9 monthsRongchang Biological Program submitted ndA for gastric and urinary skin cancer treatment to the State Drug Administration of China in the third quarter of 2020 and the first half of 2021, respectivelyin the United States, disitamab vedotin has been granted FDA qualification for an orphan medicine for gastric cancer (for the treatment of rare diseases) and has been approved by the FDA for a Phase 2 clinical study of urinary skin cancer in the United StatesRongchang Biological program in the United States in 2021 to launch disitamab vedotin treatment of urinary skin cancer and stomach cancer patients clinical studiesRC28 is a potentially first-of-its-kind vascular endothelial growth factor (VEGF)/fibroblast growth factor (FGF) dual-target fusion protein to be developed for the treatment of eye diseasesCompared to single-target VEGF inhibitors, RC28 has the potential to more effectively suppress abnormal vascular hyperploff associated with multiple eye diseases through VEGF and FGF dual channels, and may allow for better administration regimens RC28 showed good safety in the Phase 1 dose-increasing study in China in patients with wet geriatric macular degeneration (wet AMD) Rongchang Bio has initiated A Stage 1b clinical study of wet AMD and plans to launch A Stage 2 clinical study of diabetic macular edema (DME) and diabetic retinopathy (DR) in China in the second half of 2020 in addition, Rongchang Biology has five candidate drugs in clinical development, and more than five candidate drugs are in preparation for IND applications , according to the prospectus, about 45.0% of the funds raised will be used mainly for the clinical development and commercialization of candidate drugs such as Tetasip (RC18), disitamab vedotin (RC48), RC28, methpillin (ADC) RC88 and PD-L1 monoanti-RC98 (with regulatory approval), and approximately 25.0% will be used to build new production facilities to expand commercial production capacity wishes Rongchang Bio-Hkex a smooth listing process, with the help of capital, these products in research to market at an early date, benefit patients .
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