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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer
4/7/2024
Shanghai Junshi Biosciences Co., Ltd. announced that the National Medical Products Administration has approved the supplemental new drug application for toripalimab in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma.
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Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates
3/29/2024
Shanghai Junshi Biosciences Co., Ltd, announced its financial results for the full year of 2023 and provided corporate updates.
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China Medical System (867.HK)2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs
3/28/2024
On March 27, 2024, China Medical System released its 2023 annual results. The Company recorded a turnover of RMB8,013 million, a year-on-year decrease of 12.4%; in the case that all medicines were directly sold by the Group, the turnover would be RMB 9,472 million, a year-on-year decrease of 9.8%.
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Coherus BioSciences Reports Fourth Quarter, Full Year 2023 Financial Results and Provides Current Business Update
3/13/2024
Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for its fiscal fourth quarter and full year ended December 31, 2023 and recent business highlights.
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Junshi Biosciences Announces Toripalimab’s NDA Accepted by the Singapore Health Sciences Authority
2/2/2024
Shanghai Junshi Biosciences Co., Ltd announced that the Singapore Health Sciences Authority had accepted the New Drug Application for toripalimab, both in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
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Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.
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Biocytogen Launches RenBiologics, A Sub-Brand Focused on Out-Licensing Fully Human Antibodies For Therapeutic Development
1/23/2024
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announced the launch of a new sub-brand, RenBiologics™, to represent the company’s antibody discovery business division.
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Junshi Biosciences Announces JAMA Publication of Results from NEOTORCH, a Randomized Phase 3 Trial of Perioperative Toripalimab plus Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer
1/18/2024
Shanghai Junshi Biosciences Co., Ltd announced the publication of results from the prespecified interim analysis for event-free survival in patients with stage III non-Small Cell Lung Cancer of NEOTORCH in theJournal of the American Medical Association.
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Junshi Biosciences Announces Publication of Results from TORCHLIGHT, a Randomized Phase 3 Trial of Toripalimab for the Treatment of Metastatic or Recurrent Triple-negative Breast Cancer in Nature Medicine
1/10/2024
Shanghai Junshi Biosciences Co., Ltd announced the publication of results from TORCHLIGHT, a randomized, double-blind, placebo-controlled phase 3 study comparing the efficacy and safety of toripalimab versus placebo, in combination with nab-paclitaxel for patients with newly diagnosed metastatic or recurrent locally advanced triple-negative breast cancer in Nature Medicine.
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Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients
1/2/2024
Shanghai Junshi Biosciences Co., Ltd announced that the supplemental new drug application (the “sNDA”) for toripalimab (trade name: TUOYI®, product code: JS001) in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB non-small cell lung cancer (“NSCLC”) has been approved by the National Medical Products Administration.
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Coherus Announces Updated NCCN Clinical Practice Guidelines Positioning LOQTORZI™ (toripalimab-tpzi) as Preferred Category 1 Regimen for First-Line Treatment of Cancer of the Nasopharynx
12/11/2023
Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) announced today that the National Comprehensive Cancer Network (NCCN) has updated the clinical practice guidelines for nasopharyngeal carcinoma (NPC) to include LOQTORZI™ (toripalimab-tpzi) as a preferred, category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine.
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Cancer Monoclonal Antibodies Market Size Estimated to Reach USD 410.95 Billion by 2032
12/8/2023
The global cancer monoclonal antibodies market size is estimated to reach around USD 410.95 billion by 2032, increasing from USD 89.06 billion in 2023.
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Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA
12/2/2023
Shanghai Junshi Biosciences Co., Ltd announced that the TGA has accepted the NCE application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
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Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the JAMA
11/28/2023
Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd announced the publication of the final overall survival results from the pivotal JUPITER-02 study.
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Junshi Biosciences Announces Lancet Infectious Diseases Publication of Results from the 2nd Phase 3 Study of VV116 for Treating COVID-19
11/23/2023
Shanghai Junshi Biosciences Co., Ltd announced a new publication in the Lancet Infectious Diseases.
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Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights
11/6/2023
Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2023, and recent business highlights.
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Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.
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Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
10/27/2023
Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. FDA approved LOQTORZI™ in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
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Junshi Biosciences Presents 11 Clinical Trials of Toripalimab at the ESMO Congress 2023
10/27/2023
Shanghai Junshi Biosciences Co., Ltd announced the presentation of new clinical trial results at the European Society of Oncologists (“ESMO”) Immuno-Oncology Congress 2023, an international conference held in Madrid, Spain, from October 20th to 24th.