Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - It has received approvals for five products in China and international markets, including toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [9] Industry Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, including lung cancer, addressing a significant clinical need for more convenient administration methods [3][4]

Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer (NSQ-NSCLC) [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences, founded in December 2012, is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [8][10] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [9][8] Clinical Study Details - The JS001sc-002-III-NSCLC study is a multi-center, open-label, randomized Phase 3 clinical trial led by Professor Lin WU from Hunan Cancer Hospital, marking the first Phase 3 study of a domestic anti-PD-1 monoclonal antibody subcutaneous formulation [4][7] - The study results showed that the drug exposure of JS001sc was non-inferior to that of the intravenous formulation, with comparable efficacy and safety profiles [5][6] Market Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, highlighting the urgent need for more convenient administration methods [3][6]

Not for distribution by US newswire or in United States NESS-ZIONA, Israel, Nov. 24, 2025 (GLOBE NEWSWIRE) -- VAXIL BIO LTD. ("Vaxil" or the "Company") (TSX VENTURE: VXL) is pleased to announce that the Company, further to it's news release from October 29, 2025, that it has revised the terms of its previously announced offering and now intends to complete a non-brokered private placement on a commercially reasonable efforts basis (the "Offering") of up to 3,111,111 units ("Units") of the Company at a price ...

Accessibility StatementSkip Navigation BELLEVUE, Wash., Nov. 21, 2025 /PRNewswire/ -- OSR Holdings, Inc. (NASDAQ: OSRH), today announced that Vaximm AG, an OSR Company, has entered into a non-binding term sheet with BCM Europe AG ("BCME"), a Swiss-based life sciences investment group and OSRH's largest shareholder, to explore a potential exclusive global licensing agreement for VXM01, Vaximm's first-in-class oral cancer immunotherapy platform. The term sheet establishes a six-month exclusivity period during ...

Key Takeaways Regeneron won EC nod to expand Libtayo as adjuvant therapy for high-risk CSCC after surgery and radiation.FDA approved Eylea HD for RVO with dosing up to every eight weeks after an initial monthly period.The agency also cleared a monthly option of Eylea HD across wAMD, DME, DR and RVO for select patients.Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Commission (EC) has approved label expansion of its PD-1 inhibitor Libtayo (cemiplimab).The EC approved Libtayo as an adjuvan ...

Immutep (NasdaqGM:IMMP) 2025 Conference November 19, 2025 05:00 PM ET Company ParticipantsMarc Voigt - CEO and Eecutive DirectorConference Call ParticipantsNone - AnalystNoneVery good. We're going to have a bit of a fireside discussion today, which I'm very much looking forward to. Before I get to some questions, I'll just provide a brief introduction for our audience. Immutep is a clinical stage company with its lead drug candidate in phase III clinical trials for lung cancer, as well as having a second as ...

Core Viewpoint - BioVaxys Technology Corp. has successfully closed a non-brokered private placement financing, raising approximately $1.92 million through the issuance of 11,311,676 units at a price of $0.17 per unit [1][2]. Financing Details - Each unit consists of one common share and one common share purchase warrant, with the warrant allowing the purchase of an additional share at $0.40 for 24 months [2]. - The gross proceeds will be utilized for organic pipeline growth, including licensing opportunities, research collaborations, and various preclinical studies [3]. Use of Proceeds - The funds will support: 1. Licensing opportunities and research collaborations with DPX for targeted immunotherapies [3]. 2. Identifying GLP supply for preclinical studies related to peanut allergy vaccines [3]. 3. Initiating a food allergy program at McMaster University [3]. 4. Filing new patents and maintaining annuity payments for existing patents [3]. 5. Completing immunological data analysis from MVP-S phase 1 studies for out-licensing [3]. Insider Participation - CEO James Passin participated in the offering by purchasing 1,484,588 units for approximately $252,379.96, which is classified as a related party transaction [5]. Regulatory Compliance - The offering was conducted under the National Instrument 45-106, allowing units to be sold to purchasers in all Canadian provinces except Québec, without resale restrictions [3][4].

Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in CSCC in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001) Libtayo is the current standard of care in advanced CSCC in Europe, and this approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSW ...

Three BriaCell poster presentations include updated key biomarker data from BriaCell’s pivotal Phase 3 study and updated survival data from the Phase 2 study of Bria-IMT™ plus immune check point inhibitor (CPI) in metastatic breast cancer PHILADELPHIA and VANCOUVER, British Columbia, Nov. 18, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, ...

Core Viewpoint - HCW Biologics Inc. has initiated a first-in-human clinical trial for HCW9302, an innovative immunotherapeutic targeting alopecia areata, marking a significant milestone in the company's development of treatments for autoimmune diseases [1][4]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing immunotherapies aimed at chronic inflammation and age-related diseases [7]. - The company's lead product candidate, HCW9302, is a subcutaneously injectable interleukin-2 fusion molecule developed using the TOBI™ platform technology [2][7]. Product Details - HCW9302 is designed to activate and expand regulatory T cells (Treg cells), which play a crucial role in controlling excessive inflammation associated with autoimmune diseases [2][3]. - The active component, interleukin-2, is essential for maintaining Treg cell functions, which are critical in preventing immune cells from attacking the body [2]. Clinical Trial Information - The Phase 1 multi-center trial aims to treat up to 30 patients with alopecia areata, focusing on establishing the safety and recommended dose of HCW9302 [4][5]. - The trial's primary objectives include evaluating the safety of HCW9302 and determining the appropriate dose for subsequent studies, while secondary objectives will assess disease responses and Treg cell activity [4]. Market Potential - Alopecia areata affects approximately 160 million people globally, with around 7 million in the United States, representing a significant market opportunity for effective treatments [3][6]. - Current treatments for alopecia areata primarily manage symptoms rather than providing a cure, highlighting the need for innovative solutions like HCW9302 [6]. Future Development Plans - The company plans to expand clinical development of HCW9302 into Phase 2 studies for alopecia areata and other autoimmune diseases, including vitiligo and atopic dermatitis [4][5]. - Additionally, HCW9302 may be explored for its potential benefits in various inflammatory conditions and neurodegenerative diseases, such as Alzheimer's [4].