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Public company info - Clover Biopharmaceuticals Ltd. , 02197.HK

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Clover Biopharmaceuticals Ltd., 02197.HK - Company Profile
Chairman Peng LIANG
Share Issued (share) 1,158,000,000
Par Currency U.S. Dollar
Par Value 1.0E-4
Industry Biotechnology
Corporate Profile Business Summary: Founded in 2007, The group is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates for infectious diseases as well as cancer and autoimmune diseases. Performance for the year: For the years ended 2019 and 2020 and the four months ended April 30, 2021, the group experienced a loss of RMB48.6 million, RMB912.9 million and RMB909.2 million, respectively. Business Review The indications for the group’s lead product in each therapeutic area are COVID-19, malignant ascites and ankylosing spondylitis, respectively. From GenHunter, the group in-licensed the Trimer-Tag™ technology platform, a product development platform for the creation of novel vaccines and biologic therapies. the group have leveraged the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum), one of the group’s Core Products, to address the COVID-19 pandemic caused by SARS-CoV-2. Leveraging the group’s expertise in protein bioengineering, manufacturing capabilities, and in-house manufacturing facility, the group developed another Core Product, SCB-808, for the treaent of rheumatic diseases. the group’s pipeline also consists of nine additional product candidates in development as of the Latest Practicable Date. The group may not be able to successfully develop or market the group’s Core Products, namely the group’s SCB-2019 (CpG 1018/Alum) and SCB-808. The group expect to address the significant global need for COVID-19 vaccines with the group’s near-commercial protein-based COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) since there is only one fully approved COVID-19 vaccine on the market globally. In September 2021, SCB-2019 (CpG 1018/Alum) achieved the primary efficacy endpoint and secondary efficacy endpoints in SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover’s Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), the group’s global pivotal Phase 2/3 clinical trial. Based on the SPECTRA results, SCB-2019 (CpG 1018/Alum) demonstrated 100% efficacy against severe COVID-19, 100% efficacy against hospitalizations due to COVID-19, and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2 in SPECTRA. Against the globally dominant Delta variant, SCB-2019 (CpG 1018/Alum) demonstrated 79% efficacy against COVID-19 of any severity in SPECTRA. SCB-2019 (CpG 1018/Alum) also had a favorable safety profile in SPECTRA. the group will potentially become one of the first companies to commercialize a protein-based COVID-19 vaccine globally through the COVAX Facility. Compared to other non-protein-based COVID-19 vaccine candidates, protein-based COVID-19 candidates are highly stable and well-suited for global storage and distribution, can be rapidly scaled-up to large quantities using well-characterized manufacturing processes and are compatible with a diverse range of adjuvants which can potentially strengthen the immunogenicity of the vaccine. The group have built the group’s product pipeline by employing the Trimer-Tag™ technology platform and leveraging the group’s in-house biologics manufacturing infrastructure and capabilities. As of the Latest Practicable Date, the group’s product pipeline consisted of (i) six Trimer-Tag™ subunit vaccine candidates, including SCB-2019 (CpG 1018/Alum), for which the group obtained SPECTRA results in September 2021, (ii) two Trimer-Tag™ oncology product candidates, including SCB-313 for which The group is conducting five Phase 1 clinical trials in China and Australia, and (iii) three Fc-fusion product candidates, including SCB-808, for which The group is conducting a pivotal Phase 3 clinical trial in China. To date, all of the group’s product candidates were developed in-house. The chart below summarizes the development status of the group’s product candidates as of the Latest Practicable Date. The group have an in-house, commercial-ready biologics manufacturing facility in Changxing, Zhejiang province, China. This facility is prepared for the rapid scale-up and commercial production of SCB-2019. the group’s Changxing facility was designed to adhere to the cGMP standards in accordance with the U.S., EU, and Chinese regulatory authorities. The Changxing facility has received certification by a Qualified Person (QP), a requirement to achieve EU cGMP standards. the group expect the NMPA, the EMA and the WHO to conduct GMP inspections on the group’s Changxing facility in the second half of 2021 in connection with their regulatory review process for conditional approval. The group have assembled a seasoned, global management team with deep and complementary experience and capabilities in drug discovery, clinical operations, biomanufacturing, drug commercialization, and capital markets. Prospects: Leveraging the group’s strengths, the group plan to implement the following strategies: (i) accelerate the development and commercialize SCB-2019 (CpG 1018/Alum), (ii) develop the group’s secondgeneration COVID-19 vaccines, (iii) advance the development and commercialize SCB-313 and SCB-808, (iv) expand and advance the group’s product pipeline in vaccines and immuno-oncology, (v) further enhance the group’s research and development, manufacturing, and commercialization capabilities to build an integrated biotechnology company, (vi) explore synergistic and collaborative opportunities to enhance the group’s growth and increase the group’s value as a global biotechnology company.

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