JUNSHI BIO | MedPath

Junshi Biosciences Receives IND Approval for Novel Bispecific ADC Targeting EGFR and HER3

16 days ago

• China's NMPA has approved Junshi Biosciences' IND application for JS212, a first-in-class bispecific antibody-drug conjugate simultaneously targeting EGFR and HER3 in various tumor types. • The dual-targeting mechanism of JS212 potentially offers advantages over traditional single-target ADCs, including broader efficacy across multiple cancers and reduced risk of drug resistance. • BioDlink, a global CDMO with specialized ADC expertise, provided comprehensive development and manufacturing support for the technically complex bispecific ADC candidate.

Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy

3 months ago

• Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes. • The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate. • The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.

Toripalimab Approved in Australia for Nasopharyngeal Carcinoma

4 months ago

• Toripalimab, an anti-PD-1 monoclonal antibody, has been approved in Australia for the treatment of nasopharyngeal carcinoma (NPC). • The approval covers first-line treatment in combination with chemotherapy and as a single agent for recurrent or metastatic NPC after platinum-based chemotherapy. • This marks toripalimab as the first and only immuno-oncology treatment option available for NPC patients in Australia. • The approval was based on data from the JUPITER-02 and POLARIS-02 trials, demonstrating improved survival and antitumor activity.

Landmark Clinical Trials of 2024: Advancements in Cancer, Metabolic Diseases, and Infectious Diseases

5 months ago

• Moderna and Merck's mRNA-4157 combined with pembrolizumab significantly reduced melanoma recurrence risk by 44% compared to pembrolizumab alone, marking a leap in personalized cancer treatment. • Nivolumab combined with chemotherapy showed a 92% two-year progression-free survival rate in advanced Hodgkin lymphoma, offering a safer, more effective treatment option. • Junshi Biosciences' toripalimab, combined with chemotherapy, significantly improved survival in extensive-stage small cell lung cancer, establishing a new first-line treatment. • Eli Lilly's retatrutide demonstrated up to 82% liver fat reduction in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), showcasing potential in liver disease treatment.

Coherus' Casdozokitug Shows Promising Results in Liver Cancer Phase 2 Trial

5 months ago

• Coherus BioSciences presented final Phase 2 data for casdozokitug combined with atezolizumab and bevacizumab in patients with unresectable or metastatic hepatocellular carcinoma. • The trial showed a 38% objective response rate and a 17.2% complete response rate, demonstrating improved and deepened responses compared to previous data. • A new randomized Phase 2 trial has been initiated to evaluate casdozokitug in combination with bevacizumab and toripalimab for first-line hepatocellular carcinoma. • The data supports continued evaluation of casdozokitug with VEGF and PD-(L)1 blockade, highlighting its potential to address unmet needs in liver cancer treatment.

Disitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer

6 months ago

• Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC). • Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%. • The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population. • Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.

China's Biopharmaceutical Sector Achieves Record Technology Exports and FDA Approvals

6 months ago

• Chinese pharmaceutical companies saw technology exports nearly double in 2023, reaching a record high of 80 cases, signaling growing global influence. • FDA approved Junshi Biosciences' Toripalimab for nasopharyngeal cancer and Bio-Thera Solutions' Avitinib, highlighting recognition of Chinese therapies. • Multinational firms like Merck and Johnson & Johnson have invested billions in Chinese biotech, developing drugs like Carvykti for multiple myeloma. • China leads in CAR-T clinical trials, accounting for 51% globally, but Korean bio companies face stagnation in technology export amounts.

FDA and EMA Accept Biogen's Application for Higher-Dose Nusinersen (Spinraza) in SMA

6 months ago

• The FDA and EMA have accepted applications for a higher dose regimen of nusinersen (Spinraza) for treating spinal muscular atrophy (SMA). • The new regimen involves a faster loading phase with two 50 mg doses and a higher maintenance dose of 28 mg every four months. • The applications are based on the DEVOTE study, demonstrating potential clinical benefits and a safety profile consistent with the approved 12 mg regimen. • If approved, the higher dose regimen could provide meaningful improvements for individuals with SMA, addressing unmet needs in the community.

Dr. Reddy's Launches Toripalimab in India for Nasopharyngeal Carcinoma Treatment

6 months ago

• Dr. Reddy's Laboratories has launched Toripalimab in India, an immuno-oncology drug approved for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). • India is now the third country, after the U.S. and China, to have access to this next-generation PD-1 inhibitor, marketed as Zytorvi. • Clinical trials showed that Toripalimab, combined with chemotherapy, reduces the risk of disease progression or death by 48% in RM-NPC patients. • Toripalimab is also approved as a monotherapy for adults with NPC who have disease progression following platinum-containing chemotherapy.

UK Approves Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

6 months ago

• The UK MHRA has approved toripalimab in combination with chemotherapy for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). • Approval was also granted for toripalimab plus chemotherapy as a first-line treatment for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). • The approvals are supported by data from the JUPITER-02 and JUPITER-06 trials, demonstrating improved progression-free and overall survival. • Toripalimab is now the first and only drug approved in the UK for NPC treatment and the only first-line treatment for ESCC, regardless of PD-L1 status.

UK MHRA Approves Junshi Biosciences' Toripalimab for Nasopharyngeal and Esophageal Cancers

6 months ago

• The UK MHRA has approved toripalimab for recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine. • Toripalimab is also approved in combination with cisplatin and paclitaxel for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). • Toripalimab is the first and only drug approved in the UK for NPC treatment and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status. • Approvals are based on Phase 3 trials JUPITER-02 and JUPITER-06, demonstrating significant improvements in progression-free and overall survival.

UK MHRA Approves Junshi Biosciences' Toripalimab for Nasopharyngeal and Esophageal Cancers

6 months ago

• The UK MHRA has approved toripalimab for treating recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine. • Toripalimab is also approved in combination with cisplatin and paclitaxel for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). • This marks toripalimab as the first and only drug approved in the UK for NPC treatment and the only first-line option for advanced or metastatic ESCC, irrespective of PD-L1 status. • Approvals are based on Phase 3 trials JUPITER-02 for NPC and JUPITER-06 for ESCC, demonstrating significant improvements in progression-free and overall survival.

Junshi Biosciences' Ongericimab Approved in China for Hypercholesterolemia and Mixed Dyslipidemia

7 months ago

• Junshi Biosciences' ongericimab injection has been approved by China's National Medical Products Administration for treating primary hypercholesterolemia and mixed dyslipidemia. • Phase III trials demonstrated that ongericimab significantly reduces LDL-C levels by over 60% in adult patients, showcasing its efficacy in lipid-lowering. • Ongericimab's approval marks Junshi Biosciences' fifth commercial product, addressing unmet medical needs with a favorable safety profile. • The drug offers a new treatment option for patients struggling with high cholesterol and related lipid disorders, potentially improving cardiovascular health.

Toripalimab Approved in India, Hong Kong, and Europe for Nasopharyngeal and Esophageal Cancers

8 months ago

• Toripalimab gains approval in India and Hong Kong for recurrent or metastatic nasopharyngeal carcinoma (NPC) as both a first-line combination therapy and a single-agent treatment. • The European Commission approves toripalimab in combination with chemotherapy for first-line treatment of recurrent or metastatic NPC and esophageal squamous cell carcinoma (ESCC). • Approvals are based on Phase 3 JUPITER-02 and JUPITER-06 trials, demonstrating significant improvements in progression-free and overall survival compared to chemotherapy alone. • Toripalimab, developed by Junshi Biosciences, is now approved in over 30 countries and regions, marking a significant expansion of its global commercial strategy.

Junshi Biosciences' Anti-CD112R Monoclonal Antibody, TAB009/JS009, Receives FDA IND Approval for Advanced Solid Tumors

3 years ago

• Junshi Biosciences received FDA approval for its Investigational New Drug (IND) application for TAB009/JS009, an anti-CD112R monoclonal antibody, targeting advanced solid tumors. • TAB009/JS009 is designed to block the interaction between CD112R and CD112, enhancing the immune system's ability to kill tumor cells by activating T cells and NK cells. • Pre-clinical studies suggest TAB009/JS009 may synergize with TIGIT blocking antibodies and anti-PD-1 antibodies like toripalimab to further enhance T-cell activation and improve clinical efficacy.