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Hubei Guangji Pharmaceutical Expands Ex-Hospital Market Presence with New Partnerships
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China-based Hubei Guangji Pharmaceutical Co., Ltd. (SHE: 000952) is poised to establish a strong presence in the ex-hospital market, which encompasses drug sales and health services beyond public medical institutions. The company has secured separate partnerships with Qingdao Guoxin Pharmaceutical Co., Ltd and Pingguang Pharmaceutical Limited by Share Ltd to…
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GeneQuantum Healthcare’s GQ1011 (AMB302) Receives FDA Approval for Clinical Study
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China-based GeneQuantum Healthcare, a leading developer of antibody drug conjugates (ADCs), has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for GQ1011 (AMB302). This FGFR3-targeted ADC was co-developed with South Korea-based biotech Aimed Bio under an agreement established in…
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E-nitiate Biopharmaceuticals Strikes Licensing Deal with Joincare for QY101 Inhaler Rights
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China-based E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd, a joint venture between VivaVision Biotech and Betta Pharmaceuticals (SHE: 300558) focusing on autoimmune disease drug development, has entered into a licensing deal with compatriot firm Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380). Under the agreement, Joincare will acquire development and commercialization rights…
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Luye Pharma’s Subsidiary Boan Biotech Strikes Licensing Deal for Biosimilars in Brazil
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955), has announced a licensing agreement with an unnamed Brazilian partner. The agreement grants the Brazilian company the rights to commercialize Boan Bio’s BA6101 and BA1102 in the local market as their Marketing Authorization Holder (MAH).…
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Dizal Pharmaceutical Co., Ltd Scales Back Private Placement Fundraising to USD 255.1 Million
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced revisions to its private placement plan, downsizing the initially disclosed proceeds from RMB 2.608 billion (USD 360 million) in April to RMB 1.848 billion (USD 255.1 million). The adjusted funds will be allocated towards new drug research and development, a global-aligned…
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Danish Pharma H. Lundbeck A/S Sees Strong Q3 and Q1-Q3 2024 Financial Results
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Denmark-based pharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF) has revealed its financial results for the third quarter and the first three quarters of 2024. For the three-month period, revenues increased by 18% year-on-year (YOY) in constant currency terms to DKK 5.722 billion (USD 805 million). Over the nine-month period, sales…
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National Allied Procurement Office Announces Round 10 VBP Tender Program with New Rules
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The National Allied Procurement Office has released a notification regarding Round 10 of the national Volume-Based Procurement (VBP) tender program, which is scheduled to take place in Shanghai on December 12. Eligible manufacturers are required to submit information related to drug varieties via the National Medical Products Administration (NMPA) website…
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Jiangsu Chia Tai Fenghai’s ALS Treatment FHND1002 Selected for CDE’s Patient-Centered Care Plan
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China’s Center for Drug Evaluation (CDE) has announced its intention to include Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. (CTFH)’s FHND1002 granules in the patient-centered rare disease drug development pilot program, known as the Care Plan. The official announcement is expected within the coming week. FHND1002: Focusing on Patient Experience…
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Acotec Scientific Holdings Receives NMPA Approval for Thrombus Aspiration Catheter Support Tube
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombus aspiration catheter special support tube. This product is designed to assist in the delivery and placement of interventional instruments during peripheral vascular intervention surgery. Enhancing…
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Henlius Biotech Initiates Phase III Study for HLX22 in Gastric Cancer Treatment
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line…
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China’s NHC Sets Sights on Enhancing Grassroots Drug Management and Access
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The National Health Commission (NHC) has issued a set of opinions designed to accelerate the construction of a grassroots drug linkage management mechanism and to broaden the range of drugs used for chronic and common diseases in primary medical and health institutions. Provincial and Municipal Health Commissions’ Role in Drug…
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MicroPort Scientific Corp.’s BonaFire Receives NMPA Approval as First Whole-Body MRI Safety Pacing Electrode Lead
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its whole-body magnetic resonance imaging (MRI) condition safety pacing electrode lead, BonaFire. This marks a significant milestone, as BonaFire becomes the first product of its…
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Base Therapeutics’ NK510 Receives US FDA Clearance for Advanced Solid Tumor Studies
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Shanghai-based cell therapy specialist Base Therapeutics has achieved clearance from the US Food and Drug Administration (FDA) to study its NK510 in advanced solid tumors, following clinical approval in China last month. This development marks a significant step forward for the company’s base-edited universal NK cell therapy. NK510: A Leap…
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Merck KGaA Partners with NTU Singapore to Drive Digital Transformation with Trust Technology
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Merck KGaA (NYSE: MRK) has entered into a Memorandum of Understanding with the Digital Trust Centre (DTC) at Nanyang Technological University, Singapore (NTU Singapore), to implement and deploy innovative trust technology solutions. This partnership aims to drive the digital transformation of Singapore-based companies by focusing on secure, automated, traceable, and…
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GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…
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China Resources Double-Crane Gets NMPA Approval for Semaglutide Biosimilar Clinical Trial
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed as Ozempic and Wegovy. The product is set to…
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J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis
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Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab). The application is based on results from the Phase III ASTRO study and seeks approval for the drug to…
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Servier’s Vorasidenib Approved in Boao Lecheng Medical Zone for Diffuse Gliomas
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French pharmaceutical company Servier’s Voranigo (vorasidenib), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, has been granted approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. This approval comes in response to the pressing clinical needs for treatments targeting diffuse…
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Leads Biolabs’ LBL-024 Earns FDA Orphan Drug Designation for Neuroendocrine Cancer
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China-based Leads Biolabs Inc. has announced that it has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its anti-PD-L1/4-1BB bispecific antibody, LBL-024. This designation is for the treatment of neuroendocrine cancer, a rare and aggressive form of cancer. Mechanism of Action and Preclinical EfficacyLBL-024…
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Signet Therapeutics’ SIGX1094 Earns Orphan Drug Designation for Gastric Cancer from FDA
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China-based Signet Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its FAK-targeted drug, SIGX1094, which is being developed to treat gastric cancer. This designation highlights the potential impact of SIGX1094 in addressing a significant unmet medical need. SIGX1094:…
