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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
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The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520) finotonlimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb), for use in combination with platinum-based chemotherapy as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Sunshine Lake Pharma’s Antaitasvir…
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Sinocelltech’s Herpes Zoster Vaccine SCTV04C Clears NMPA for Clinical Trial
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for SCTV04C, its proprietary recombinant herpes zoster vaccine. Herpes zoster, commonly known as shingles, is an infectious skin condition that results from the reactivation of…
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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
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Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its monoclonal antibody SCTC21C, targeting CD38+ hematological malignant tumors. This development marks a significant step forward in…
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Chinese Firms Secure EUAs for Omicron XBB Vaccines Amid Dominant Variant Surge
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A wave of Chinese pharmaceutical companies has announced the receipt of Emergency Use Authorizations (EUAs) for their COVID-19 vaccines targeting the Omicron XBB variant. Among the notable developments are Lizhu Pharmaceutical’s (HKG: 1513) recombinant bivalent vaccine, which combines the prototype strain with the Omicron XBB variant, and CanSino Biologics’ (SHA:…
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Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
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Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and…
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Sinocelltech Group Receives NMPA Approval for Bevacizumab Biosimilar for Multiple Cancers
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. This biosimilar will be used to treat a range of cancers including metastatic colorectal cancer (CRC), recurrent glioblastoma, advanced metastatic or recurrent non-small cell lung…
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Sinocelltech Group Receives NMPA Approval for COVID-19 Vaccine Bridging Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals…
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Sinocelltech Group Launches Biosimilar Version of AbbVie’s Humira in China
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China-based Sinocelltech Group Ltd (SHA: 688520) has officially commercialized its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab), marking a significant milestone in the Chinese biosimilar market. The company has delivered the first batch of the biosimilar product, achieving commercialization in less than two weeks following regulatory approval. Humira’s Global…
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Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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BioRay Pharmaceutical’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment
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BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone…
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Sinocelltech’s SCTV01C Vaccine Included in China’s Emergency Use Program
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the inclusion of its recombinant novel coronavirus alpha+beta mutant S-trimer protein vaccine SCTV01C in the emergency use program in China. SCTV01C is a next-generation bivalent mutant recombinant protein vaccine being developed to prevent diseases caused by COVID-19. The active ingredient of SCTV01C contains…
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Sinocelltech’s SCTV01E Vaccine Receives NMPA Approval for Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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Sinocelltech’s COVID-19 Vaccines SCTV01C and SCTV01E Show Promising Phase III Results
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced the preliminary interim analysis results of a Phase III clinical study for its in-house developed recombinant COVID-19 vaccines. The study evaluated the bivalent (Alpha + Beta variants) S trimer protein vaccine SCTV01C and the quadrivalent (Alpha + Beta + Delta + Omicron…
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China Pharma H1 2022 Financials: 40% of Firms Report Revenue and Profit Growth
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A total of 449 pharmaceutical and health-tech companies listed in China have released their H1 2022 financial reports, with over 40% reporting growth in both revenues and net profits. Among these, 14 companies recorded net profits exceeding RMB 2 billion (USD 287 million). Andon Health led the pack with RMB…
