Bamlanivimab/etesevimab

Junshi Biosciences Announces 2022 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Friday, March 31, 2023

SHANGHAI, China, March 31, 2023 (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 financial results for the 2022 full year and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 31, 2023 (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 financial results for the 2022 full year and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB 2,384 million in 2022, representing an increase of approximately 15% compared to 2021.
  • Loss attributable to the owners of the company was RMB 2,386 million in 2022, representing an increase of RMB 1,667 million compared to 2021.
  • In May 2022, the IND application for JS105, a PI3K-α inhibitor jointly developed by Risen (Suzhou) Biosciences Co., Ltd. (“Risen Biosciences”) and the company, was approved by the NMPA.

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

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

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

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).

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor)

Retrieved on: 
Friday, August 26, 2022

So far, 6 innovative drugs in Junshi Biosciences pipeline have obtained IND approval from the FDA, and with this newest addition, there are now 7.

Key Points: 
  • So far, 6 innovative drugs in Junshi Biosciences pipeline have obtained IND approval from the FDA, and with this newest addition, there are now 7.
  • Junshi Biosciences currently owns the world-wide exclusive production rights, licensed production rights and sales rights for JS110.
  • 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, Guangzhou, etc).

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

Retrieved on: 
Thursday, August 18, 2022

SHANGHAI, China, Aug. 17, 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 Company has received an Acceptance Notice issued by the National Medical Products Administration (“NMPA”). The supplemental application for additional indications of the company’s adalimumab injection (project code: UBP1211, trade name: 君迈康), including the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children, has been accepted.

Key Points: 
  • The supplemental application for additional indications of the companys adalimumab injection (project code: UBP1211, trade name: ), including the treatment of Crohns disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohns disease in children, has been accepted.
  • 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 has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).

Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022

SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Coherus and Junshi Biosciences Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022

REDWOOD CITY, Calif., and SHANGHAI, China, July 06, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint

Retrieved on: 
Wednesday, May 25, 2022

SHANGHAI, China, May 25, 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 Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 (JT001) and nirmatrelvir/ritonavir (“PAXLOVID”) in the treatment of patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 including death, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 (JT001) provided patients with a shorter median time to sustained clinical recovery, achieving statistical superiority.

Key Points: 
  • The NCT05341609 study is a multicenter, single-blind, randomized, controlled Phase III study evaluating the efficacy and safety of VV116 (JT001) in comparison with PAXLOVID in the early treatment of patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 and death.
  • The results of this Phase III study, evaluating VV116 (JT001) as a treatment for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 and death, show that the predetermined primary endpoint has been reached.
  • VV116 is currently in an international, multicenter Phase III trial, and a number of clinical studies for mild, moderate and severe COVID-19 are in progress.
  • In 2021, VV116 was approved in Uzbekistan for the treatment of patients diagnosed with moderate to severe COVID-19.

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

Retrieved on: 
Sunday, April 3, 2022

TAB009/JS009 is a recombinant humanized IgG4 monoclonal antibody against human CD112R developed independently by Junshi Biosciences, for the treatment of advanced malignant tumors.

Key Points: 
  • TAB009/JS009 is a recombinant humanized IgG4 monoclonal antibody against human CD112R developed independently by Junshi Biosciences, for the treatment of advanced malignant tumors.
  • The investigational new drug application for TAB006/JS006 has already been approved by both Chinas National Medical Products Administration (NMPA) and the U.S. FDA.
  • 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 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).