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    Home > Active Ingredient News > Drugs Articles > Rongchang Creatures through the Hong Kong Stock Exchange hearing! The luxury executive team is commercializing two new drugs

    Rongchang Creatures through the Hong Kong Stock Exchange hearing! The luxury executive team is commercializing two new drugs

    • Last Update: 2020-10-31
    • Source: Internet
    • Author: User
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    On October 21, the HKEx website information shows that Rongchang Biopharmaceuticals (Yantai) Co., Ltd. ("Rongchang Bio") has passed the hearing and is expected to become the 23rd innovative pharmaceutical company to land on the HKEx after the introduction of the New Deal. founded in 2008,
    Rongchang Bio is committed to the discovery, development and commercialization of first in class and best-in-class biopharmaces, for autoimmune, oncology, ophthalmology and other major diseases to create a number of major clinical value of biological new drugs, research and development investment in the past three years between 200 million and 400 million.
    According to the prospectus, nearly half of Rongchang Bio's planned IPO funds will be used for clinical development and commercialization of products such as Tate Sipp (RC18), Vidicido Single Resistance (RC48), VEGF/FGF Dual Target Fusion Protein RC28, with the remainder being used to build new production facilities to expand commercial production capacity, repay loans and general business operations.
    products: 2 new drugs submitted for listing, more than 10 models in the research from the product pipeline, Rongchang Bio based on its unique antibodies and fusion protein platform, antibody conceded drug platform, dual-functional antibody platform developed more than 10 products in research, there are currently 5 for 17 adaptive diseases in clinical trials, including In November 2019, the application for the listing of a new drug for the treatment of systemic lupus erythematosus (SLE) (NDA) was submitted to the NMPA and was included in the priority review of Tetasip, and in August this year, the application for listing was submitted and included in the priority review of the first domestic antibody coupled drug (ADC) Vidixito monotherapy.
    Rongchang Bio-Product Pipeline ADC has been one of the key areas of Rongchang Bio-layout development.
    , Rongchang Bio has established an industry-leading end-to-end ADC platform over the past eight years, covering the discovery/optimization, processing/analysis development and production of new ADC therapeutic drugs, according to the prospectine.
    Rongchang Bio is currently using the platform to develop four ADC candidate drugs, in addition to Vidicido monoanti, and RC88 (MSLN ADC) is in clinical development, RC108 (c-Met ADC) has declared IND, RC118 (target unknown) is in the pre-IND stage.
    So far, 10 ADC drugs have been approved for market worldwide, while Only two ADC drugs have been approved for listing in China, namely Roche's Enmetro-Zhuda and Takeda's Vibutoxi monoanti.
    nearly 30 ADCs in China are in clinical trials, the fastest of which is Rongchang Bio's Vidicyto monoantigen, which is expected to become the first ADC drug to be approved by NMPA.
    Vidicyto monoantigen contains the humanized HER2 antibody and the toxin payload methyl auretatin E (MMAE), which are coupled with each other by shearable connections that can be cut by tissue proteases and have an optimized drug-antibody ratio.
    Rongchang Bio submitted a clinical application for Vidicido monoantigen in September 2014 and received clinical approval in October 2015, which is the first ADC project to enter clinical trials in China.
    differs from other ADC project preferred adaptive options for HER2 high expression of breast cancer, Rongchang Bio has chosen two adaptive diseases of urethra skin cancer and stomach cancer as the entry point, and has obtained good clinical data.
    In a Phase II registered clinical trial of HER2 over-expression (IHC 2 plus or IHC3 plus) localized advanced or metastatic gastric cancer (GC) or gastroesophageal binding (GEJ) cancer, Vidicido monoantigen achieved IRC assessment with a confirmed ORR of 24.4% and a medium PFS of 4.1 months and a medium OS of 7.6 months.
    Based on this result, Rongchang Bio has submitted a conditional listing application to CDE in August this year for the treatment of patients with locally advanced or metastatic stomach cancer, including gastroesophageal adenocarcinoma, which is the first self-developed ADC drug in China to submit an application for the listing of a new drug.
    in a Phase II clinical trial of patients with HER2 overexpression (IHC 2 plus or IHC 3 plus) metastatic or non-excisive urethroid skin cancer (UC), the optimal total remission rate (BOR) of Vidisitto monoantigen was 60.5%, the confirmed ORR was 51.2% and the medium PFS was 6.9 months.
    , the second-line treatment of UC patients with PD-1/PD-L1 inhibitors was only 20% to 30% and the medium PFS was 2 to 3 months.
    Vidicyto monoantigen can bring greater benefits to patients with metastatic UC, which also earns FDA-awarded breakthrough therapy qualifications for patients with second-line treatment HER2 expression (IHC2 plus or IHC 3 plus) for local late stage or metastatic urethroid skin cancer.
    addition, Vidicido has been awarded the FDA's orphan drug for stomach cancer and fast-track eligibility.
    Rongchang Bio began to lay out the ADC field as early as eight years ago, and the global heat in the ADC field in the last two years also confirms the forward-looking strategy of its project.
    fda has approved five new ADC drugs in a row since June 2019, and ADC-related deals have been hot in the near term.
    September 13 this year, Gilead announced a $210 acquisition of Immunomedics to acquire the latter's Trap-2 antibody consumable drug Trodelvy.
    , Mercadon and Seattle Genetics reached a $3.6 billion partnership to obtain joint development and commercial rights to the latter's ADC drug ladiratuzumab vedotin, which targets zinc ion transport protein LIV-1.
    recently, East China Pharmaceuticals also announced a $300 million interest in a first-in-class ovarian cancer ADC drug from ImmunoGen.
    in addition to Vidicito monoantigen, Thetasip, developed by Rongchang Bio, is also a representative Chinese original innovative drug and a breakthrough in the treatment of systemic lupus erythematosus (SLE).
    target two important signaling molecules associated with B-cell-mediated autoimmune diseases, BLyS and APRIL, for the treatment of B-cell-mediated autoimmune diseases.
    November 2019, the State Drug Administration accepted the NDA for Tate SLE and granted priority review eligibility, which is expected to be approved and commercialized by the end of this year.
    January 2020, the FDA approved a Phase III clinical trial of Thalesip SLE adaptation in the United States and granted fast-track eligibility.
    Currently, Tatsip is also conducting Phase III clinical trials in China for rheumatoid arthritis and optic neurospinalitis, and adaptations such as dry syndrome, IgA nephropathy, multiple sclerosis and severe muscle weakness are also being conducted in China.
    In addition, Rongchang Bio also has potential product layout in the field of ophthalmology treatment, including the pioneering VEGFR/FGFR dual-target fusion protein product RC28 for several ophthalmological diseases, including wet geriatric macular degeneration (wet AMD), diabetic macular edema (DME) and diabetic retinal lesions (DR).
    as a whole, Rongchang bio-product pipeline development stage and disease field is clearly divided, is a relatively healthy situation.
    team: veteran industry veteran Rongchang Bio can get a first-in-the-nation position at the ADC circuit, but also inseparable from the star-studded core management team behind it.
    it's not hard to find that its executive team members have an average of more than 20 years of industry experience and successful experience in innovative drug development, clinical development and commercialization.
    co-founder, CEO and CSO Fang Jianmin is one of the few founders of domestic biopharmaceutical companies with experience from the discovery of new drugs to the successful commercialization.
    Has more than 20 years of experience in biopharmaceutical research and development and more than 40 drug invention patents, is China's "major new drug creation" national science and technology major special overall expert group members.
    rongchang Bio's other star executive is Dr. He Rui, who is the chief medical officer.
    served as CDE's chief scientist and pushed through a number of important policy reforms.
    prior to that, he worked for the FDA and the China Drug Administration for nearly 20 years, including more than 17 years at the FDA, where he held various strategic leadership positions, chaired the drafting of a number of final pharmaceutical industry guidelines, and participated in the development of FDA guidelines in multiple therapeutic areas.
    also a star executive is Dr. Fu Daotian, who is the former vice president of Lizhu Group, general manager of Lizhu Single Anti-Biotech Co., Ltd., in Rongchang Bio as president.
    according to the prospectine, Fu Daotian has more than 20 years of experience in international biopharmaceity research and development, project and personnel management experience, including production process design and development, analysis platform establishment, quality standards recognition and international declaration.
    At the same time, Rongchang Bio has established a Scientific Advisory Board, composed of five leading professors and key opinion leaders in the field of research and development, including Dr. Yan Gang, Dr. Fang Jianmin, Dr. Ho Rui, Dr. Marsha A. Moses and Dr. Lorenne Babiuk, to provide professional advice on product development and commercialization of Rongchang Bio.
    addition, Rongchang Bio has built a team of nearly 1,000 employees, including 482 research and development and clinical developers, and its business team has begun to build, with a commercial team of about 100 expected by the end of this year.
    : The Pre-IPO phase is close to 10 billion yuan since its inception in 2008, Rongchang Bio has been favored by many star capital.
    According to the prospectine, Rongchang Bio's shareholders include investors from the capital backgrounds of China Venture Capital, Shenzhen Venture Capital and other countries, as well as Lilly Asia, Obo Capital, Qingchi Capital, Zhengxing Valley Innovation and other professional biomedical investment institutions.
    the restructuring at the end of 2019, Rongchang Bio began to raise separate financing.
    In December 2019, the company received about RMB90 million in investments from tai alliance investment and other institutions, with a valuation of about RMB 5,447 million at that time, and in March 2020, the company was awarded US$105 million by Lilly Asia, Obo Capital, Qingchi Capital, Zhengsingu Innovation and other professional biomedical investment institutions, with a valuation of nearly RMB10.372 billion.
    addition, the sponsor of Rongchang Bio's IPO is also a great success in the field of biomedicine.
    Among them, Morgan Stanley has served as an underwriting agency for Keystone Pharmaceuticals, Consino Bio, Henson Pharmaceuticals, Corninger, Nordson Jianhua, Converse Bio, and Oconway Bio; Huatai International has served as an underwriting agency for pioneering pharmaceuticals; and J.P. Morgan has served as a co-sponsor of Converse Bio.
    after the hearing Rongchang Bio is about to open the new share purchase link, and what "cornerstone investors" will be the first to enter the market? We will continue to pay attention.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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