Junshi

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Friday, March 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Retrieved on: 
Friday, October 27, 2023
HKEX, FDA, Junshi, SSE, PD-L1, Glomus tumor, Skull, Survival, Harvard Medical School, Primary tumor, Incidence, Aes, Food, Progression-free survival, DCR, Sun, Cisplatin, PFS, Conference, PD-1, CHRS, CCR8, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, HIV disease progression rates, NPC, Assistant professor, Immune system, Neoplasm, Risk, Pharynx, Radiation, ORR, Platinum, Tumor microenvironment, Cancer, Ira Pastan, Patient, OS, Death, Toxicity, Nose, Palladium, Pharmaceutical industry

REDWOOD CITY, Calif. and SHANGHAI, China, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and  Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) today announced that the U.S. Food and Drug Administration (FDA) approved LOQTORZI™ (toripalimab-tpzi) 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. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

Key Points: 
  • The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status.
  • LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
  • “Following etesevimab, toripalimab has become Junshi Biosciences’ second product to receive FDA approval for commercialization—an achievement that will further enhance the company’s international presence.
  • Currently, the establishment of toripalimab’s global commercialization network is in progress, and the network aims to span over 50 countries.

Junshi Biosciences Presents 11 Clinical Trials of Toripalimab at the ESMO Congress 2023

Retrieved on: 
Friday, October 27, 2023
Junshi, Shanghai Jiao Tong University School of Medicine, SSE, Kidney cancer, Cervical cancer, Trial of the century, Manuscript, Axitinib, ESMO, III, Renal cell carcinoma, Lung cancer, Colorectal cancer, Head, Congress, PFS, Renji Hospital, Carcinoma, Impact, Thymus, Research, HIV disease progression rates, RCC, Development, Apoptosis, Clinical trial, Risk, Breast cancer, Immunotherapy, ORR, European Society for Medical Oncology, Patient, Hospital, Death, IRC, Lymphoma, Pharmaceutical industry

At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.

Key Points: 
  • At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.
  • “This year’s ESMO Congress highlighted the most recent results from 11 clinical studies conducted with our core product, toripalimab,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences.
  • Study findings were unveiled for the first time during a proffered paper session at the ESMO Congress.
  • In terms of safety, toripalimab combined with chemotherapy has a manageable safety profile and no new safety signals were identified.

Junshi Biosciences Announces Initiation of Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer

Retrieved on: 
Thursday, June 29, 2023
Carcinoma, Progression-free survival, Survival, Lung cancer, Cancer, Cardiac resynchronization therapy, Prognosis, SOC, NSCLC, Trial of the century, Global Research, SCLC, BTLA, Junshi, SSE, Development, HIV disease progression rates, Patient, Standard of care, Mortality, Hospital, MOS, Chemoradiotherapy, CRT, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Small-cell carcinoma, Pharmaceutical industry

According to GLOBOCAN 2020, lung cancer is a form of malignant tumor with the highest incidence rate and mortality in China.

Key Points: 
  • According to GLOBOCAN 2020, lung cancer is a form of malignant tumor with the highest incidence rate and mortality in China.
  • Lung cancer can be broadly categorized into non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), based on cell type.
  • Specifically, small cell lung cancer is the most invasive subtype of lung cancer, accounting for about 15%-20% of all lung cancer cases with characteristics such as rapid progression, early metastasis, and poor prognosis.
  • Small cell lung cancer includes limited-stage small cell lung cancer (“LS-SCLC”) and extensive-stage small cell lung cancer, and LS-SCLC accounts for about one-third of all small cell lung cancer cases.

Junshi Biosciences Announces Toripalimab plus Chemotherapy Significantly Improved Event-free Survival (EFS) versus Chemotherapy as Perioperative Treatment for Resectable Stage III Non-small Cell Lung Cancer (NSCLC) in Phase 3 Neotorch Study

Retrieved on: 
Thursday, April 20, 2023
Maintenance, MPR, NSCLC, Chlorine, PCR, ASCO, Junshi, SSE, HKEX, Patient, Risk, HR, EFS, Death, III, PD-L1, Safety, Pharmaceutical industry, Vaccine

Neotorch is the world’s first phase 3 registered study demonstrating that perioperative treatment with anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable non-small cell lung cancer (NSCLC).

Key Points: 
  • Neotorch is the world’s first phase 3 registered study demonstrating that perioperative treatment with anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable non-small cell lung cancer (NSCLC).
  • It aims to evaluate the efficacy and safety of perioperative toripalimab, Junshi Biosciences’ anti-PD-1 monoclonal antibody, in combination with chemotherapy, followed by toripalimab maintenance versus perioperative chemotherapy alone in resectable stage II/III NSCLC.
  • The median EFS was not reached in the toripalimab arm while it was 15.1 months in the placebo arm.
  • The median OS was not reached in the toripalimab arm, while it was 30.4 months in the placebo arm (HR=0.62).

Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Retrieved on: 
Sunday, December 25, 2022
Junshi, HKEX, PDUFA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SSE, BLA, COVID-19, CHRS, Travel, Patient, Biologics license application, Safety, FDA, Cisplatin, Senior, NPC, Pharmaceutical industry, Agency

SHANGHAI, China and REDWOOD CITY, Calif., Dec. 25, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) by the Prescription Drug User Fee Action (PDUFA) date of December 23, 2022.

Key Points: 
  • The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.
  • “Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences.
  • Both Coherus and the FDA are highly committed to bringing toripalimab to NPC patients in the U.S. as quickly as possible,” said Theresa LaVallee, Ph.D., Coherus’ Chief Development Officer.
  • Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Retrieved on: 
Saturday, December 24, 2022
Junshi, HKEX, PDUFA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SSE, BLA, COVID-19, CHRS, Travel, Patient, Biologics license application, Safety, FDA, Cisplatin, Senior, NPC, Pharmaceutical industry, Agency

SHANGHAI, China, and REDWOOD CITY, Calif., Dec. 24, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) by the Prescription Drug User Fee Action (PDUFA) date of December 23, 2022.

Key Points: 
  • The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.
  • “There is a significant unmet need for those living with NPC, and toripalimab has demonstrated significant and clinically meaningful improvement as recognized by the FDA’s Breakthrough Therapy Designation.
  • Both Coherus and the FDA are highly committed to bringing toripalimab to NPC patients in the U.S. as quickly as possible,” said Theresa LaVallee, Ph.D., Coherus’ Chief Development Officer.
  • Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

Junshi Biosciences Announces Updated Clinical data from Phase I study of anti-BTLA antibody Tifcemalimab in Treatment of Relapsed/Refractory Lymphomas at 64th ASH Annual Meeting

Retrieved on: 
Saturday, December 10, 2022
Neoplasm, SD, Marketing, ASH, DCR, B-cell lymphoma, American Society of Clinical Oncology, Research, Junshi, COVID-19, Lilly, NMPA, Clinical trial, Oncology, FDA, Lymphoma, Safety, Bamlanivimab, Cancer, PD-1, Social responsibility, Immunoglobulin superfamily, Dor, DLT, Society, CD28, Hodgkin lymphoma, HL, ASCO, TNF, ORR, Bamlanivimab/etesevimab, Ira Pastan, NHL, SSE, Development, Patient, Time-invariant system, HVEM, Poster, Microbiology, BTLA, EUA, HKEX, Lymphocyte, Infection, Autoimmunity, Severe acute respiratory syndrome coronavirus 2, Pharmaceutical industry, Vaccine, Medical imaging, Science, Chinese, Hematology

SHANGHAI, China, Dec. 10, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the updated preliminary data from a Phase I study of tifcemalimab as a single agent or in combination with toripalimab in relapsed/refractory lymphomas in a poster at the 64th American Society of Hematology (ASH) Annual Meeting. Tifcemalimab is the world’s first-in-human anti-tumor anti-BTLA monoclonal antibody independently developed by the company.

Key Points: 
  • The observed clinical activity of tifcemalimab in combination with toripalimab in lymphoma patients refractory to checkpoint inhibitors warrants further evaluation.
  • “However, if PD-1 inhibitors fail, there is no standard treatment to resort to, thus new treatment methods are urgently needed in clinical practice.
  • This is the very first time an anti-BTLA antibody was evaluated for safety and efficacy in the treatment of lymphomas.
  • Now, updated results from the clinical trial for lymphomas have been presented at the ASH annual meeting.

Junshi Biosciences Announces Approval of Supplemental Application for Additional Indications of Adalimumab Injection

Retrieved on: 
Tuesday, November 22, 2022
Autoimmunity, Marketing, Bamlanivimab/etesevimab, Macular edema, EUA, Rheumatism, Severe acute respiratory syndrome coronavirus 2, NMPA, Junshi, B cell, Inflammatory bowel disease, Incidence, TNF, Prevalence, Microbiology, Patient, IBD, Rheumatoid arthritis, HKEX, Ulcerative colitis, Cataract, UC, FDA, Multifocal choroiditis and panuveitis, COVID-19, Adalimumab, SSE, Glaucoma, Cancer, Ankylosing spondylitis, Lilly, Inflammation, Retinopathy, Social responsibility, Severe cognitive impairment, Juvenile idiopathic arthritis, National Medical Products Administration, Degenerative disease, Macrophage, Bamlanivimab, Infection, Quality of life, Psoriasis, Uveitis, Pharmaceutical industry, Vaccine, Science, Chinese

is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd.

Key Points: 
  • is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd.
  • In March 2022, its indications including rheumatoid arthritis, ankylosing spondylitis and psoriasis were approved by the NMPA.
  • Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, September 20, 2022
OS, World, Safety, Lancet, ALK, PD-L2, Society, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Patient, Hospital, Somatic mutation, Research, Death, EUA, COVID-19, HKEX, NSCLC, National Medical Products Administration, Program, Ligand, SSE, Microbiology, NMPA, Mortality, EGFR, Peking Union Medical College, Autoimmunity, Junshi, Risk, FDA, ASCO, Social responsibility, Severe acute respiratory syndrome coronavirus 2, Bamlanivimab/etesevimab, Medicine, Progression-free survival, GLOBE, Marketing, Platinum, HIV disease progression rates, Cancer, Development, Incidence, World Health Organization, American Society of Clinical Oncology, Lung cancer, Pemetrexed, Lung, HR, PD-L1, PD-1, Bamlanivimab, Lilly, PFS, Infection, Pharmaceutical industry, Chinese, Science

This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

Key Points: 
  • This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.
  • Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimabs performance in clinical trials.
  • In China, the number of lung cancer patients is massive and so is the demand for treatment.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).