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UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
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Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
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UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
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Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
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Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
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Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate…
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Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval to Test KYS202004A for Psoriasis
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate, KYS202004A, in the treatment of psoriasis. KYS202004A: A Dual-Targeted Fusion Protein for PsoriasisKYS202004A is an…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
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Sunshine Guojian Pharmaceutical Secures NMPA Approval for Clinical Trials of SSGJ-626 in Lupus Indications
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody, SSGJ-626. This BDCA2-targeted mAb will now enter trials for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), indications that have…
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GSK Secures Global Rights to Chimagen Biosciences’ T Cell-Engager in $850 Million Deal
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UK pharmaceutical company GSK plc (NYSE: GSK) has entered into a licensing agreement with Chimagen Biosciences, securing all global rights to CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE). GSK will pay an upfront fee of USD 300 million and is committed to making success-based development and commercial…
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Innovent Biologics’ Picankibart Shows 64.6% Skin Clearance in Phase II Psoriasis Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced encouraging results from the multi-center, open Phase II study of its picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. The study focused on psoriasis patients with a poor response to prior biologic treatments, primarily IL-17 antibodies. After 16 weeks of treatment…
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Eli Lilly’s Ebglyss Shows Positive Results in Phase III Study for Atopic Dermatitis Patients Previously Treated with Dupilumab
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Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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AstraZeneca’s Saphnelo Approved for Use in Guangdong Under ‘Hong Kong-Macau Drug Access’ Policy
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase II UC Study
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial for picankibart, an anti-IL-23p19 antibody injection, has successfully met its primary endpoint in Chinese patients with moderately to severely active ulcerative colitis (UC). The multi-center, randomized, double-blinded, placebo-controlled study (NCT05377580)…
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Eli Lilly’s Mirikizumab Shows Statistically Significant Improvement in Crohn’s Disease VIVID-1 Study
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the U.S., has published the results of the VIVID-1 study, demonstrating the efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed that mirikizumab achieved nominally statistically significant improvements across all histological and histological…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its Zoryve cream (roflumilast) in concentrations of 0.15% and 0.3%. These formulations are indicated for the treatment of mild to moderate atopic dermatitis…
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Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis. Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody…
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China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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UCB’s Bimzelx Gains FDA Approval for Three Additional Autoimmune Indications
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
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Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200,…
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J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
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US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
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Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
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Jiangsu Hengrui Medicine Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
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Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
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Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board (SHA: 688799), has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, ZG-002. This new molecule is intended for…
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Bio-Thera Solutions Expands Reach with New Licensing Deal for Biosimilar BAT2306
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a new licensing agreement with Russian firm Pharmapark LLC for BAT2306, a biosimilar of Roche’s Cosentyx (secukinumab). Under the terms of the agreement, Pharmapark will hold exclusive commercialization rights for the drug in Russia and the CIS region. Bio-Thera will oversee the…
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Huadong Medicine Secures Licensing Deal with IMBiologics for Autoimmune Drug Candidates
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Huadong Medicine Co., Ltd. (SHE: 000963), a Chinese pharmaceutical company, has entered into a licensing agreement with South Korea’s IMBiologics, securing development, regulatory filing, manufacturing, and commercialization rights for the autoimmune drug candidates IMB-101 and IMB-102. This agreement spans China and 36 additional Asian countries, excluding Japan, South Korea, and…
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IASO Biotechnology’s CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
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IASO Biotechnology, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
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3SBio Subsidiary Achieves Milestone in Phase III Psoriasis Trial with SSGJ-608
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical study for the drug candidate SSGJ-608 has successfully met all primary endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all…
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Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
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CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone…
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Genor Biopharma Strikes Licensing Deal with TRC 2004 for Global Rights to GB261 Outside Greater China
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China-based Genor Biopharma Co., Ltd (HKG: 6998) has entered into a significant licensing and equity agreement with US-based TRC 2004, Inc., bestowing upon TRC 2004 the exclusive rights to develop, manufacture, and commercialize Genor’s innovative drug candidate, GB261, in all global territories excluding Greater China. This strategic partnership is set…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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IASO Biotechnology, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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Eli Lilly’s Lupus Treatment LY3361237 Misses Mark in Phase II Trial
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Eli Lilly & Co. (NYSE: LLY) has encountered a setback in its drug development pipeline with the failure of the Phase II trial for LY3361237, an antibody agonist targeting the BTLA immune checkpoint, in the treatment of systemic lupus erythematosus (SLE). The trial, registered on clinicaltrials.gov as NCT05123586, was terminated…
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Everest Medicines’ Velsipity Shows Positive Results in Largest Asian Phase III UC Trial
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced positive top-line results from a multi-center Phase III clinical study for its Velsipity (etrasimod) in moderate-to-severe active ulcerative colitis (UC) during the maintenance period in Asia. This landmark trial is the largest Phase III study for moderately-to-severely…
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Kymera Therapeutics’ Stock Soars on Sanofi’s Plans to Expand KT-474 Clinical Trials
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Kymera Therapeutics Inc. (NASDAQ: KYMR), a biopharmaceutical company based in the U.S., has announced that Sanofi intends to expand the clinical development program for the auto-immune skin disease drug KT-474 following a preliminary review that showed robust early data. Sanofi’s plan to broaden Phase II trials for the drug, which…
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China’s Kingfriend Biochemical Acquires U.S.-Listed Adalimumab Biosimilar Yusimry for USD 40 Million
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Nanjing Kingfriend Biochemical Pharmaceutical Co., Ltd (SHA: 603707), a Chinese pharmaceutical company, has announced the acquisition of Yusimry, a biosimilar of adalimumab, from U.S. firm Coherus Biosciences (NASDAQ: CHRS) for a purchase price of USD 40 million. This deal includes the marketing approval, patents, and related assets of the drug,…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for CD47 and CD20 Dual-Targeted BsAb in SLE
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for IMC-002, a bispecific antibody (BsAb) targeting CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE). IMC-002 is designed to enhance antibody dependent cell phagocytosis…
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RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
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RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
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AbbVie Strikes Deal with FutureGen for Global Rights to Next-Gen TL1A Antibody FG-M701
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AbbVie (NYSE: ABBV), a biopharmaceutical giant based in the US, has announced a licensing agreement with Beijing-based biotech FutureGen Biopharmaceutical Co., Ltd. The agreement centers around FutureGen’s preclinical asset, FG-M701, a next-generation TL1A antibody being developed for the treatment of irritable bowel disease (IBD). In this deal, AbbVie secures exclusive…
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SinoMab BioScience’s SM17 Atopic Dermatitis Drug Reaches First Patient Milestone in Phase Ib Trial
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SinoMab BioScience Ltd (HKG: 3681), a biotech firm based in Hong Kong, has announced the first patient dosing in a Phase Ib clinical study for SM17, a pioneering drug for atopic dermatitis (AD). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SM17, along with preliminary efficacy,…
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Johnson & Johnson to Acquire Biotechnology Firm Yellow Jersey for $1.25 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has entered into a definitive agreement with RTW Biotech Opportunities, a U.S. investment fund, for the acquisition of biotechnology firm Yellow Jersey. Yellow Jersey, a subsidiary of Swiss-based Numab, was previously acquired by RTW in 2021. The cash transaction, valued…
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InnoCare Pharma’s TYK2 Inhibitor ICP-332 Receives FDA IND Approval for Atopic Dermatitis
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InnoCare Pharma (HKG: 9969, SHA: 688428), a biopharmaceutical company based in China has announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its TYK2 inhibitor, ICP-332. This development marks a significant step forward for the company as it seeks to expand its…
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Biosion’s Bosakitug Shows Positive Results in Atopic Dermatitis Phase II POC Study
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Biosion, a clinical-stage biotechnology company with operations in Delaware, U.S., and China, has announced key findings from its Phase II proof-of-concept (POC) ADAMANT study for bosakitug, a candidate in its pipeline for the treatment of atopic dermatitis (AD). Bosakitug is a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP),…
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JW Therapeutics Presents Positive Clinical Data for Carteyva in SLE at EULAR 2024
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active…
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Johnson & Johnson to Acquire Atopic Dermatitis Therapy NM26 in $1.25 Billion Deal
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has entered into a definitive agreement to acquire global rights to NM26, a first-in-class bispecific antibody (BsAb) for the treatment of atopic dermatitis (AD), from Switzerland-based Numab Therapeutics. The transaction, valued at $1.25 billion in cash, is anticipated to conclude…
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Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
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Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
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Roche’s Genentech Gets Green Light for Vixarelimab UC Clinical Trial in China
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Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
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Changchun High & New Technology Industries Gets Green Light for Jinnamab Clinical Trial
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Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product, jinnamab. This marks a significant milestone for the…
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BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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J&J Acquires Immune-Mediated Diseases Specialist Proteologix in a Deal Worth Up to USD 850 Million
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has announced a deal to acquire Proteologix, a US-based specialist in immune-mediated diseases, for a base purchase price of USD 850 million with additional potential milestone payments. The transaction is anticipated to be finalized by mid-2024. Proteologix is known for…
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Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SHR-2173, an investigational biologic, in patients with IgA nephropathy. Developed in-house, SHR-2173 is designed to target abnormally…
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RemeGen’s Telitacicept Achieves Full Enrollment in Phase III Primary Sjogren’s Syndrome Trial
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the completion of patient enrollment in a Phase III clinical study for its drug candidate telitacicept in primary Sjogren’s syndrome (pSS) in China. The study aims to evaluate the efficacy and safety of telitacicept in pSS, with a total of 381 patients…
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Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in Macau has approved the New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC). This makes Macau the first region in Everest’s licensed territory in Asia to grant approval…
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LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
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Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar (LEO 90100) in a Phase III clinical trial conducted in China. The trial focused on evaluating Enstilar as a potential treatment for Chinese patients with stable plaque psoriasis. The primary objective of the study was…
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Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This approval marks the…
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German Study Highlights Potential of Amgen’s Blinatumomab in Treating Rheumatoid Arthritis
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Researchers from Germany’s University of Erlangen-Nuremberg have unveiled promising clinical data on the use of bispecific T cell engagers (BiTes) in combating B-cell mediated autoimmune diseases, such as rheumatoid arthritis (RA). The study, titled “Bispecific T cell engager therapy for refractory rheumatoid arthritis,” published in Nature Medicine in December 2023,…
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AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
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AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
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Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib, a potential best-in-class BTK inhibitor, has successfully met its primary endpoint of durable platelet response in patients with immune thrombocytopenia (ITP). The trial also produced positive results in key secondary endpoints and did not raise…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
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The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
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AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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Novartis’s Fabhalta Shows Promise in Phase III IgA Nephropathy Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive preliminary results from a Phase III clinical trial of its complement inhibitor Fabhalta (iptacopan) for the treatment of IgA nephropathy (IgAN). The trial data showed that after a nine-month treatment period, the Factor B inhibitor Fabhalta reduced proteinuria by 38.3% when…
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Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study for its Category 1 product, jacktinib cream, in adolescent and adult patients suffering from non-segmental vitiligo. Jacktinib, a Janus kinase (JAK) inhibitor, exhibits…
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Vertex Pharmaceuticals to Acquire Alpine Immune Sciences in a $4.9 Billion Deal
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In a multibillion-dollar deal within the biotechnology sector, Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), a leader in genetic disease treatment, has entered into an agreement to acquire Alpine Immune Sciences (NASDAQ: ALPN), a U.S.-based company specializing in protein engineering for immunotherapies. The transaction, valued at approximately USD 4.9 billion, is anticipated…
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Jiangsu Hengrui Medicine Advances Pipeline with NMPA Approvals for Three Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the…
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China Medical System Expands Portfolio with Incyte’s Povorcitinib for Autoimmune Diseases
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China Medical System Holdings (CMS; HKG: 0867) has announced a new cooperation and licensing agreement with US-based Incyte Pharmaceuticals Inc. (NSDQ: INCY), focusing on Incyte’s selective oral JAK1 inhibitor, povorcitinib. CMS has secured the exclusive rights to research, develop, file for regulatory approval, and commercialize the drug in Greater China,…
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Lynk Pharmaceuticals Doses First Patient in Phase III Trial for Atopic Dermatitis Treatment
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Lynk Pharmaceuticals Co., Ltd, based in China, has announced the dosing of the first patient in a Phase III clinical study for its highly selective JAK1 inhibitor, LNK01001, aimed at treating atopic dermatitis (AD). This randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of LNK01001 in…
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China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding…
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Sanofi’s Amlitelimab Shows Promising Phase IIb Results in Atopic Dermatitis, Potential for 12-Week Dosing
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Sanofi (NASDAQ: SNY) announced this week promising results from a Phase IIb study of its OX40-ligand blocker, amlitelimab, in patients with moderate to severe atopic dermatitis. The study focused on participants who demonstrated a favorable response after an initial 24-week treatment period. Following a subsequent 28-week maintenance or withdrawal phase,…
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Jiangsu QYuns Therapeutics Eyes HK IPO to Raise Up to HKD 243 Million for Autoimmune Pipeline
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Jiangsu QYuns Therapeutics Co., Ltd. (HKG: 2509), based in China, is poised to launch an initial public offering (IPO) of 12,046,400 shares on the Hong Kong Stock Exchange, with a pricing range set between HKD 19.8 and HKD 20.2 per share. The company anticipates raising between HKD 239 million and…
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Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
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Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4 inhibitor Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis in patients aged 6 to 17 years. The one-year data revealed that 56.3% of participants achieved clear or almost clear skin, while 71.4%…
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Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
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The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an IL-23 monoclonal antibody, is set to undergo priority review for the treatment of moderate to severe active Crohn’s disease (CD). The drug, which previously received breakthrough therapy designation (BTD) status, is already approved for use…
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Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
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Viatris Secures Late-Stage Programs from Idorsia with Potential for Future Asset Additions
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US pharmaceutical company Viatris (NASDAQ: VTRS) has entered into a licensing agreement with Swiss drugmaker Idorsia (SWX: IDIA), in-licensing two late-stage programs with the option to add two more innovative assets in the future. Viatris will pay Idorsia an upfront fee of USD 350 million, along with potential milestone payments…
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Everest Medicines Gets CDE Approval for Global Phase IIb Study of Zetomipzomib in Lupus Nephritis
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to proceed with the global, placebo-controlled Phase IIb PALIZADE study. The study aims to assess the efficacy and safety of zetomipzomib in patients with active lupus nephritis (LN).…
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Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
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The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
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Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD),…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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AbbVie Expands Licensing Agreement for Innovative sCAR-T Platform with Scripps Research
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AbbVie (NYSE: ABBV) has expanded its collaboration with Scripps Research’s Calibr-Skaggs Institute, securing licensing rights to the institute’s investigational switchable CAR-T (sCAR-T) platform, which has shown promising early-stage results. The agreement entails an upfront payment, along with potential milestone payments and royalties, allowing AbbVie to access the program for up…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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AbbVie Reports $54.3 Billion in 2023 Revenues Amid Humira Erosion and Segment Variability
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AbbVie (NYSE: ABBV) reported revenues of $54.3 billion for 2023, reflecting a 5.9% year-on-year decline at constant currency rates, as the company grapples with the erosion of its flagship immunosuppressant, Humira (adalimumab). While the neuroscience and aesthetics segments showed resilience with revenue increases of 18.5% and 0.9%, generating $7.7 billion…
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Chongqing Genrix Bio Pharmaceutical Gets NMPA Clearance for IL-4Rα mAb Candidate GR1802
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Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443), a Chinese biopharmaceutical company, has announced that it has received clinical trial clearance from the National Medical Products Administration (NMPA) for its investigational drug candidate GR1802, an interleukin-4 receptor α (IL-4Rα) monoclonal antibody (mAb). The drug is intended to be assessed as…
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Inmagene Biopharmaceuticals Secures Exclusive License for HutchMed’s Drug Candidates IMG-007 and IMG-004
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that Sino-US biotech Inmagene Biopharmaceuticals has exercised its option to license two drug candidates discovered by HutchMed, IMG-007 and IMG-004, under the terms of a strategic partnership signed on January 11, 2021. Upon the exercise of these options and subject to…
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Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
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The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
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IASO Biotechnology Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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China-based IASO Biotechnology has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
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Sanofi’s Dupixent Receives FDA Label Update for Atopic Dermatitis Patients with Hand or Foot Involvement
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Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage…
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Novartis Acquires Calypso Biotech for USD 250 Million to Bolster IL-15 Pipeline
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Novartis (NYSE: NVS) has finalized an agreement to acquire Netherlands-based Calypso Biotech, a 2013 spinout from Merck that specializes in targeting interleukin-15 (IL-15). Under the terms of the deal, Calypso will receive an upfront payment of USD 250 million, along with potential milestone payments totaling up to USD 175 million.…
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AbbVie’s Lutikizumab Advances to Phase III for Hidradenitis Suppurativa After Positive Mid-Stage Results
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AbbVie (NYSE: ABBV) has announced the progression of lutikizumab to Phase III clinical trials following the IL1α/1β antagonist’s successful performance in a mid-stage trial for patients with moderate-to-severe hidradenitis suppurativa (HS) who had failed anti-TNF therapy. The study successfully met its primary endpoint, demonstrating a 35% higher clinical response rate…
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Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
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Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets IL-17A, has received an additional indication approval from the National Medical Products Administration (NMPA) in China. The drug is now approved for the treatment of active psoriatic arthritis (PsA), adding to its existing indications in…
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Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
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The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is poised to receive priority review status for the local topical treatment of atopic dermatitis (AD) in patients aged two years and above. This priority status is granted due to the drug’s classification under “new varieties,…
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Genrix Bio Seeks China Approval for New Xeligekimab Use in Axial Spondyloarthritis
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Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted a new indication filing for its innovative biologic product xeligekimab, which has now been accepted for review by the National Medical Products Administration (NMPA). This latest filing seeks approval for xeligekimab to treat radiologically…
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BMS’s Sotyktu, First TYK2 Inhibitor, Hits Chinese Market
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US pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced the market launch of Sotyktu (deucravacitinib) in China, marking a significant milestone for the treatment of moderate to severe plaque psoriasis. Sotyktu is recognized as the world’s first and only TYK2 allosteric inhibitor, suitable for patients eligible for systemic…
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JW Therapeutics and 2seventy Bio Ink Exclusive Deal for CAR-T Cell Therapy in Greater China
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JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has announced an exclusive collaboration agreement with US biotech firm 2seventy Bio Inc. (NASDAQ: TSVT) to jointly develop, manufacture, and commercialize an unspecified chimeric antigen receptor (CAR)-T cell therapy product for autoimmune diseases in the Greater China region. JW will…
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AbbVie and Alpine Immune Sciences Halt Early Enrollment in Lupus Trial
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AbbVie (NYSE: ABBV) and Alpine Immune Sciences (SWX: ALPN) have made the decision to prematurely cease enrollment in a Phase II trial for the T-cell stimulatory pathways inhibitor acazicolcept in systemic lupus erythematosus (SEL). This move allows for an early assessment of the trial data and enables Alpine to redirect…
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Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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RemeGen’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to proceed with a global multi-center Phase III clinical study for its fusion protein drug telitacicept in the treatment of active primary Sjogren’s syndrome (pSS). This 48-week, multi-center, randomized, double-blinded, placebo-controlled Phase…
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Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
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China-based Lynk Pharmaceuticals Co., Ltd has announced that the first patient has been dosed in a Phase III clinical study for its drug candidate LNK01001, which is being developed to treat rheumatoid arthritis (RA). The trial is supported by Lynk’s commercialization partner, Simcere Pharmaceutical Group (HKG: 2096), and is being…
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InnoCare’s TYK2 Inhibitor ICP-332 Shows Positive Results in Atopic Dermatitis Phase II Study
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Beijing InnoCare Pharma Tech Co., (HKG: 9969), a Chinese biotechnology company specializing in oncology and autoimmune diseases, has reported positive outcomes from a Phase II clinical trial for its tyrosine kinase 2 (TYK2) inhibitor, ICP-332. The randomized, double-blind, placebo-controlled study is investigating the efficacy of ICP-332 in patients with moderate…
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BMS Broadens Scope of IMID Collaboration, Aiming for Deeper Insights into Sjögren’s and Atopic Dermatitis
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Bristol Myers Squibb (BMS; NYSE: BMY) has expanded its 2016 partnership with IMIDomics, broadening the collaboration’s focus to include the collection of clinical and epidemiological data from patients with Sjögren’s disease and atopic dermatitis. This initiative aims to enhance the understanding of the underlying mechanisms of these immune-mediated inflammatory diseases…
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J&J Forecasts 5-7% CAGR Through 2030, Driven by Innovative Medicine and Device Growth
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Johnson & Johnson (J&J; NYSE: JNJ) has presented an update on its business strategy, pipeline, and financial outlook amidst the loss of exclusivity for its blockbuster immunosuppressant Stelara (ustekinumab) in the US. The company anticipates operational sales growth of 5% to 6% in 2024 and 3% or more in 2025,…
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Worg Pharmaceuticals Gets FDA Approval for Phase II Graves’ Disease Study
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Worg Pharmaceuticals, a Hangzhou-based developer of allergic drugs, has received the green light from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its drug candidate WP1302 in the treatment of Graves’ disease. Graves’ disease, a prevalent autoimmune condition, impacts an estimated 10…
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Everest Medicines Secures IND Review for Zetomipzomib in China
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Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for zetomipzomib has been accepted for review by China’s National Medical Products Administration (NMPA). Zetomipzomib is a first-in-class selective immunoproteasome inhibitor currently under development for a variety of autoimmune diseases, including lupus nephritis and systemic lupus erythematosus…
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Akeso’s AK111 Achieves Key Efficacy Milestones in Phase III Trial for Plaque Psoriasis
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Akeso Biopharma (HKG: 9926), based in China, has announced that its pivotal Phase III clinical trial for the interleukin (IL)-17A monoclonal antibody (mAb) AK111 in moderate to severe plaque psoriasis has successfully met all primary efficacy endpoints, including PASI100 and sPGA0/1. This randomized, double-blind, placebo-controlled, multi-center study was designed to…
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Insilico Medicine Launches Clinical Study for First-in-Class PHD Inhibitor ISM5411 in IBD
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Insilico Medicine, a China-based biotech leveraging generative artificial intelligence (AI), has announced the initiation of a clinical study for its potential first-in-class PHD inhibitor, ISM5411, targeting inflammatory bowel disease (IBD). ISM5411 is an intestinal-restricted small-molecule inhibitor developed using Insilico’s Pharma.AI platform, featuring a novel molecular framework and a unique binding…
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Everest Medicines Reports Positive Phase III Results for Velsipity in Ulcerative Colitis
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Everest Medicines (HKG: 1952), based in China, has announced positive topline results from a multi-center Phase III clinical trial for Velsipity (etrasimod) in patients with moderate-to-severe active ulcerative colitis (UC). Conducted across various sites in Asia, the trial demonstrated clinically meaningful and statistically significant improvements in the primary endpoint, as…
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Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in South Korea
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by South Korea’s Ministry of Food and Drug Safety (MFDS). The therapy is under consideration for approval as a treatment for primary immunoglobulin A nephropathy…
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Gracell Biotechnologies Gets FDA Green Light for FasTCAR-T Therapy in Systemic Lupus Erythematosus
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Gracell Biotechnologies Inc., a Suzhou-based biotech company (NASDAQ: GRCL), has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical study for its FasTCAR-T GC012F in the United States. The CAR-T therapy is set to be assessed as a treatment for refractory systemic lupus…
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Everest Medicines’ Nefecon for IgAN Receives NMPA Approval in China
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for Nefecon (targeted-release formulation budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression has been approved by the National Medical Products Administration (NMPA). Nefecon is a…
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RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
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Q32 Bio Reclaims Development Rights to Anti-IL-7Rα Biologic from Amgen
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Biotechnology firm Q32 Bio has announced its decision to reclaim full development and commercial rights to its anti-IL-7Rα biologic, bempikibart, from US-based Amgen (NASDAQ: AMGN). The biologic is currently in middle-stage trials for autoimmune diseases. This move follows Amgen’s acquisition of Horizon Therapeutics earlier this year, which had entered into…
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AbbVie Partners with Sinopharm to Enhance Novel Drug Accessibility and Patient Management
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US pharmaceutical giant AbbVie (NYSE: ABBV) has entered into a strategic partnership with Sinopharm Group Co., Ltd, (HKG: 1099) a leading Chinese pharmaceutical company, to improve access to novel drugs and explore standardized patient management practices in China. Expanding Access and Patient SupportThe collaboration will utilize Sinopharm’s extensive SPS+ professional…
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Janssen Presents Real-World Data on Tremfya’s Efficacy in Treatment-Resistant Psoriatic Arthritis
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical unit, Janssen, has presented real-world efficacy data for Tremfya (guselkumab), an IL-23p19-subunit inhibitor, in the treatment of treatment-resistant active psoriatic arthritis (PsA). The data provides valuable insights into the drug’s performance in alleviating pain, improving physical function, and reducing fatigue in patients with…
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Janssen’s Nipocalimab Shows Promising Results in Phase II Rheumatoid Arthritis Trial
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced the results of a Phase II trial for nipocalimab, a potential best-in-class anti-neonatal Fc (FcRn) biologic, in patients with moderate-to-severe active rheumatoid arthritis (RA) who have anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and are unresponsive to…
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Yirui Pharmaceutical’s YR001 Completes Successful Phase I Clinical Study in the US
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Hangzhou-based Yirui Pharmaceutical Technology Co., Ltd has announced the successful conclusion of a Phase I clinical study for its YR001 external preparation in the United States. The topical ointment, which is a small molecule Kv1.3 inhibitor, showed a good safety and tolerability profile in all subjects tested. YR001: Indications and…
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AbbVie’s Q3 2023 Report Shows 6.0% YOY Decline in Net Revenues
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AbbVie (NYSE: ABBV) released its Q3 2023 financial report last week, revealing a 6.0% year-on-year (YOY) decline in net revenues for the first nine months of the year, amounting to USD 40.0 billion. The decrease was attributed to underperformance across most business areas, with the exception of neuroscience, which reported…
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Everest Medicines’ Nefecon Receives First Regional NDA Approval in Macau for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. This marks the first regional…
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Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
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AbbVie Partners with Lupus Therapeutics to Advance Rinvoq in SLE Treatment
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AbbVie (NYSE: ABBV) announced this week a strategic collaboration with US-based Lupus Therapeutics aimed at accelerating the late-stage development of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of systemic lupus erythematosus (SLE). This partnership marks a significant step in expanding the therapeutic applications of Rinvoq, which is already approved…
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Novartis Q3 Earnings Reflect Strong Growth Post-Sandoz Spinoff
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Novartis (NYSE: NVS) has released its Q3 2023 financial results, marking the first report since the company sharpened its focus on innovative medicines following the spinoff of Sandoz (SWX: SDZ) earlier this month. The financials reveal a robust performance with net sales reaching USD 34.0 billion for the first nine…
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BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
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The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
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Boehringer Ingelheim’s Vitiligo Drug EI-001 Approved for Clinical Trials by NMPA
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Germany’s Boehringer Ingelheim (BI) has announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) filing for EI-001, a Category 1 vitiligo drug co-developed by Elixiron Immunotherapeutics. This approval marks a significant milestone in the development of new treatment options for vitiligo, a condition that…
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Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP). Mechanism of Action and Broader Implications…
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AbbVie’s Rinvoq Demonstrates Sustained Efficacy in Late-Stage Atopic Dermatitis Study
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AbbVie (NYSE: ABBV) has announced late-stage results for its JAK inhibitor Rinvoq (upadacitinib) in the treatment of moderate-to-severe atopic dermatitis, a skin condition characterized by inflammation and itching. The data, released this week, highlights the drug’s performance over an extended period of two years. Sustained Efficacy in Atopic DermatitisThe primary…
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Janssen Unveils Promising Clinical Data on IL-23 Blockers for Psoriasis
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) is showcasing new clinical data this week from trials assessing the efficacy of IL-23 blockers, Tremfya (guselkumab) and JNJ-2113, in the treatment of psoriasis. The findings, derived from a late-stage study, reveal that Tremfya facilitated clear skin within 28 weeks…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sanofi Enters Collaboration with Teva for IBD Drug TEV’574 Development
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Sanofi (NASDAQ: SNY) has entered into a collaboration agreement with Teva (NYSE: TEVA) for the joint development and commercialization of Teva’s Phase II drug candidate, TEV’574, targeting inflammatory bowel diseases (IBD). This investigational molecule is designed as a potential best-in-class anti-TL1A therapy aimed at treating ulcerative colitis (UC) and Crohn’s…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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Merck Forges Partnerships with BenevolentAI and Exscientia for Precision Drug Discovery
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German pharmaceutical company Merck (NYSE: MRK) has announced two separate strategic collaborations with UK-based artificial intelligence-driven precision drug design companies BenevolentAI (AMS: BAI) and Exscientia (NASDAQ: EXAI). These partnerships aim to discover potential first-in-class and best-in-class small-molecule therapies in the fields of oncology, neurology, and immunology. Terms of Collaboration and…
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Lynk Pharmaceuticals Secures Series C2 Financing to Advance pipeline
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Lynk Pharmaceuticals Co., Ltd, a China-based pharmaceutical company, has announced the successful completion of its Series C2 financing round. The round saw participation from the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund, managed by China Grand Prosperity Investment, Haibang Venture, and Howbuy Primary Fund, with existing shareholders New…
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Jiangsu Hengrui Medicine Wins NMPA Approval for Two Novel Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
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Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
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Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
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Menarini Group Secures Exclusive License for Astellas’ Smyraf in Taiwan
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A. Menarini Asia-Pacific Holdings Pte. Ltd, a subsidiary of the Italy-based Menarini Group, has entered into a long-term exclusive licensing agreement with Japan-headquartered Astellas Pharma Inc (TYO: 4503). The partnership grants Menarini the rights to develop, manufacture, and commercialize the orally administered Janus kinase (JAK) inhibitor Smyraf (peficitinib hydrobromide) in…
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FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
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The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been…
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AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
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AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
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JW Therapeutics and 2seventy Bio Expand Partnership for Cell Therapy Development
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China-based cell therapy firm JW Therapeutics (HKG: 2126) and US biotech 2seventy Bio Inc., (NASDAQ: TSVT) have announced plans to build on their 2022 collaboration agreement. The latest deal grants JW Therapeutics the option to develop up to two additional candidate drugs from 2seventy Bio’s product portfolio, including a T…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
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SinoMab BioScience Receives NMPA Approval for Phase I Study of Atopic Dermatitis Drug SM17
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Hong Kong-based biotechnology company SinoMab BioScience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in China, assessing the safety of SM17, a first-in-class drug for atopic dermatitis (AD). The study is set to commence in the fourth quarter…
