Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Operable NSCLC Patients
Junshi Biosciences Announces Phase 3 Clinical Study of Senaparib for Advanced Ovarian Cancer Maintenance Treatment Following First-line Therapy Met Primary Endpoint
Junshi Biosciences Announces Establishment of Joint Venture with Rxilient Biotech to Jointly Develop and Commercialize Toripalimab in Southeast Asia
Junshi Biosciences Announces Ongericimab (anti-PCSK9 mAb) Met Primary Endpoints in Two Phase 3 Clinical Studies
Junshi Biosciences Announces Toripalimab in Combination with Chemotherapy for Treatment of Advanced Triple-negative Breast Cancer Met Primary Endpoint in Phase 3 Clinical Study
Junshi Biosciences and Coherus Announce Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Clinical Trial Evaluating Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma
Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study
Junshi Biosciences Announces NEJM Publication of Results of Phase 3 Study of VV116 Versus PAXLOVID for Adults at High Risk for Progression to Severe COVID-19
Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region
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
- Preliminary study results show that tifcemalimab is well-tolerated at all administered doses. The observed clinical activity of tifcemalimab in combination with toripalimab in lymphoma patients refractory to checkpoint inhibitors warrants further evaluation. Combination dose expansion is under way.
- Among the 28 evaluable patients who received the combination regimen, while 85.7% of the patients progressed upon prior anti-PD-1, 39.3% achieved ORR, and median DoR has not yet been reached.
Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency
2nd MAA submission in Europe reflects toripalimab’s steady yet speedy progress towards global commercialization
Junshi Biosciences Announces Submission of a Marketing Authorization Application to the European Medicines Agency for Toripalimab
The MAA was submitted in the EU for toripalimab seeking indications for the 1st line treatment of NPC and the 1st line treatment of ESCC
The global commercialization plan for toripalimab has expanded from China to the US and now, the EU
Junshi Biosciences Receives Orphan Medicinal Product Designation from the European Committee for Toripalimab in Treatment of Nasopharyngeal Carcinoma
- 6th Orphan Drug Designation granted to toripalimab in the US and EU
Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
FDA has set a target action date of December 23, 2022 for the toripalimab BLA –
Toripalimab will be the first and only immuno-oncology agent for NPC in U.S., if approved
Junshi Biosciences Highlights Pipeline Advances in Immuno-Oncology Through Nearly 40 Data Presentations of Icatolimab and Toripalimab at ASCO 2022
June 06, 2022
Favorable preliminary safety and efficacy data for anti-BTLA monoclonal antibody, icatolimab, for the treatment of lymphoma and solid tumors.
Toripalimab continues to demonstrate synergy as the cornerstone in innovative combination therapies
VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint
- the study reached its primary endpoint(VV116 was statistically superior) and secondary efficacy endpoint
- VV116 has a favorable safety profile and fewer adverse events than PAXLOVID
Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Paclitaxel and Cisplatin in First-Line Treatment of Advanced or Distant Metastatic Esophageal Squamous Cell Carcinoma
May 16, 2022
5th approved indication by NMPA significantly expands eligible patient population
Junshi Biosciences and Coherus Present Results of Phase 3 Study of Toripalimab in First Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma at 2022 AACR Annual Meeting
Toripalimab plus chemotherapy provided superior progression free survival, overall survival, overall response rate and duration of response compared to chemotherapy alone
Junshi Biosciences and Coherus Announce Presentation of Positive Results from CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer, at March ASCO Plenary Series
March 15, 2022
Toripalimab plus chemotherapy met both primary endpoint of progression free survival and prespecified secondary endpoint of overall survival compared to chemotherapy alone
Data support the use of toripalimab with chemotherapy as first-line treatment for advanced NSCLC patients without EGFR/ALK mutations
Junshi Biosciences and Coherus Announce Positive Results from Phase 3 Esophageal Cancer Study of Toripalimab Published in Cancer Cell
- Toripalimab plus chemotherapy demonstrates improvement in co-primary endpoints of PFS and OS in patients with advanced ESCC
- PFS and OS benefits were observed across all PD-L1 expression subgroups, including in patients with low PD-L1 expression
Coherus and Junshi Biosciences Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody
January 10, 2022
- Coherus and Junshi Biosciences plan to evaluate the toripalimab + JS006 combination in clinical trials in multiple tumor types
- Combinations of PD-1 + TIGIT inhibitors have potential to expand checkpoint inhibitor utilization to new tumors and lines of therapy
Junshi Biosciences and Coherus Announce Positive Interim Overall Survival Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer
Junshi Biosciences and Coherus to meet with US FDA to discuss 1L NSCLC BLA supplement submission
Junshi Biosciences Announces FDA Expanded Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Individuals under the Age of 12
December 05, 2021
First and only neutralizing antibody therapy for this age group
Junshi Biosciences Announces Two Additional Indications for Toripalimab Included in China’s National Reimbursement Drug List
The only anti-PD-1 monoclonal antibody in the NRDL for melanoma and nasopharyngeal carcinoma
Junshi Biosciences Announces Approval of Supplemental New Drug Application by NMPA for Toripalimab in Combination with Cisplatin and Gemcitabine as First-Line Treatment for Patients with Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
November 29, 2021
4th approved indication for toripalimab
Coherus and Junshi Biosciences Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer
Junshi Biosciences and Coherus Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma
November 01, 2021
FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022
TopAlliance Appoints Virginia Ellen Maher, MD, as Vice President of Medical Sciences
Junshi Biosciences Announced Results from JUPITER-02 Published in September Issue of Nature Medicine
Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the addition of toripalimab to standard of care gemcitabine-cisplatin (GP) chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC provided superior progression free survival (PFS) compared to GP alone [median PFS of 11.7 vs 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003], and with a manageable safety profile. The impact of the addition of toripalimab on PFS was demonstrated in patients regardless of PD-L1 expression status. Although overall survival data were not yet mature, as of February 18, 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364–0.997)). The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), TEAEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal TEAEs (2.7% vs 2.8%) was similar between both arms. Immune-related adverse events (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab arm. The full results can be found in the on-line edition of Nature Medicine.
“There are currently no PD-1 blocking antibodies approved for NPC in the United States. We are pleased that this study has been selected for cover article publication in this highly-respected journal,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “This is a strong signal that further validates the potential advance that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC, an aggressive and difficult-to-treat cancer.”
A biologics license application has been submitted to the U.S. Food and Drug Administration (“FDA”) for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
The JUPITER-02 Study (ClinicalTrials.gov identifier: NCT03581786) is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical trial comparing the efficacy and safety of toripalimab versus placebo in combination with Gemcitabine/Cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Professor Ruihua Xu from Sun Yat-sen University Cancer Centre is the lead principal investigator of the study. The largest Phase 3 clinical trial to date evaluating a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, JUPITER-02 was conducted in mainland China, Taiwan and Singapore and enrolled a total of 289 patients.
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.
In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.
About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.
Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; Coherus’ and Junshi Biosciences’ plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021
and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.
Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
Junshi Biosciences and Coherus to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma
Positive Interim Results of CHOICE-01 Study Evaluating Junshi Biosciences and Coherus’ Toripalimab for First Line Treatment of Non-Small Cell Lung Cancer Presented at World Conference on Lung Cancer
Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma
1st line nasopharyngeal indication and 2nd/3rd line indications to be concurrently submitted 3Q 2021 in the toripalimab BLA
Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Coherus and Junshi Biosciences Announce Toripalimab in Combination with Chemotherapy Met Primary Progression Free Survival (PFS) Endpoint as First Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
- In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1 expression subgroups.
- Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo.
- Data to be presented June 6, 2021 at ASCO plenary session.
- Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021.
Junshi Biosciences and Coherus Announce Toripalimab First-Line Nasopharyngeal Carcinoma Clinical Data to be Showcased in Plenary Session at 2021 ASCO Annual Meeting
Toripalimab data will also be featured in ASCO’s official press program
Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer Reached Primary Endpoints in Phase III Clinical Study
NMPA Approves Toripalimab in Patients with Locally Advanced or Metastatic Urothelial Carcinoma who Failed Platinum-Containing Chemotherapy or Progressed within 12 Months of Neoadjuvant or Adjuvant Platinum-Containing Chemotherapy
- 3rd indication approved for Toripalimab in China
Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma
- BLA submitted with FDA’s breakthrough therapy designation
Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China
- Junshi grants AstraZeneca exclusive promotion rights of toripalimab in mainland China for the urothelial carcinoma indications and for all indications in non-core areas
- Junshi will continue to be responsible for the promotion of other indications in core areas
- The companies will continue to explore business collaborations in overseas markets including emerging markets
NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy
- 1st approval of any checkpoint inhibitor in nasopharyngeal carcinoma in the world
- 2nd indication approved for Toripalimab in China
Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19
- Etesevimab and bamlanivimab administered together is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19
- More than 250,000 doses manufactured throughout Q1 2021; up to 1 million doses by mid-2021
- FDA authorizes shortened infusion time for this neutralizing antibody therapy authorized for emergency use
Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 Antibody, Toripalimab, in U.S. and Canada
- Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada
- The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year
New data show treatment with etesevimab (JS016) and bamlanivimab together reduced risk of COVID-19 hospitalizations and death by 70 percent
- Trial met primary endpoint and key secondary endpoints with high statistical significance
- Results from more than 1,000 high-risk patients were consistent with previous data
- In November, Lilly submitted a EUA request to the FDA for etesevimab and bamlanivimab together for mild to moderate COVID-19 in high-risk patients, which remains under review by the FDA
- Findings from BLAZE-4 trial provide data on lower doses of etesevimab and bamlanivimab together
FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma
- U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma.
- FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).
CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC
- Independent Data Monitoring Committee (IDMC) has determined that Toripalimab (product code: JS001) in combination with standard chemotherapy as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) has reached its pre-specified primary endpoint of Progression Free Survival (PFS) at the interim analysis of a randomized, double-blind, multi-center, phase III clinical study “CHOICE-01” (Clinicaltrial.gov identifier: NCT03856411).
- The Company will initiate the process to submit a supplemental New Drug Application (NDA) to the National Medical Products Administration (NMPA) in the near future.
Combination Study with JS016 and LY-CoV555 for Patients with Mild-to-Moderate COVID-19 Symptoms Met Primary and Secondary Endpoints
- Viral load, symptoms, and hospitalizations or ER visits reduced
- Request for EUA and BLA filings for the combination therapy anticipated in Nov 2020 and as early as 2Q2021, respectively
- Large scale open-label study planned in coming weeks
JUPITER-02 Phase III Global Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma
- Independent Monitoring Committee (IDMC) determined that the randomized, double-blind, placebo-controlled, international multi-center Phase III study JUPITER-02 at the interim analysis had met its pre-specified primary endpoint.
- The results of the study showed that Toripalimab in combination with Gemcitabine/Cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) significantly extended the progression-free survival than the current standard treatment of Gemcitabine/Cisplatin.
- The Company will submit biologic license application (BLA) to the National Medical Products Administration (the “NMPA”) and regulatory authorities in other relevant countries in the near future.
Junshi Biosciences Receives FDA Breakthrough Therapy Designation for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
First anti-PD-1 antibody from China to receive BTD
- US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma.
- Toripalimab is the first anti-PD-1 antibody from China to receive the Breakthrough Therapy designation, which is another important regulatory milestone for Toripalimab after FDA granted orphan drug designation for this indication in May 2020.
TopAlliance Appoints Patricia Keegan, M.D., as Chief Medical Officer
- TopAlliance Biosciences, a wholly own subsidiary of Shanghai Junshi Biosciences today announced the appointment of Dr. Patricia Keegan, as Chief Medical Officer and Senior Vice President.
- Dr. Keegan brings over three decades of experience as a board-certified medical oncologist, clinical researcher, and regulatory authority at FDA.
Revitope And Junshi Biosciences Enter Into Research Collaboration And License Agreement
Novel antibody-based cancer immunotherapies to be developed through combining Revitope’s dual-antigen precision T-cell engager platform (TEAC) and Junshi Biosciences’ antibodies
Revitope to design up to 5 TEAC molecules against tumor targets selected by Junshi Biosciences
For each TEAC molecule selected, Revitope to receive up to $160M in development and commercialization milestones, plus tiered royalties on net sales
Junshi commits to making a conditional equity investment of $10M for 9.99% of Revitope Oncology shares on an as-converted basis
Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of SARS-CoV-2 Neutralizing Antibody JS016
- Discovery, development, and commercialization of novel therapies, announced today the completion of study subjects enrollment in Phase I trial of SARS-CoV-2 neutralizing monoclonal antibody injection (Product Code: JS016), developed jointly with Institute of Microbiology, Chinese Academy of Sciences (IMCAS).
- JS016 is the first COVID-19 neutralizing antibody entering clinical trials in China. It also entered in clinical trials in the US during the second quarter.
Nature Publishes Preclinical Characterization and Primate Efficacy Data on Junshi Biosciences’ COVID-19 Neutralizing Antibodies
- CB6 demonstrated prophylactic and treatment effects in rhesus monkeys
- Clinical testing expected to begin in second quarter in collaboration with Eli Lilly and Company