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Akeso Biopharma Reports 53% Revenue Decline in 2024 Despite Growth in Product Sales
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China-based Akeso Biopharma (HKG: 9926) released its 2024 financial report, recording RMB 2.124 billion (USD 293 million) in revenues, a 53.08% year-on-year (YOY) decrease. Despite the overall revenue decline, product sales grew significantly to RMB 2 billion (USD 276 million), up 24.88% YOY. Licensing income was reported at RMB 121.6…
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TransThera and Akeso Biopharma Collaborate on HCC Study with Tinengotinib and Bispecific Antibodies
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Chinese companies TransThera Sciences (Nanjing) Inc. and Akeso Biopharma (HKG: 9926) have formed a strategic research collaboration to advance an open, multi-center Phase II study combining TransThera’s tinengotinib (TT-00420) with Akeso’s cadonilimab or ivonescimab for advanced hepatocellular carcinoma (HCC). The National Medical Products Administration (NMPA) has granted clearance for the…
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Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
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China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
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Akeso Inc. Completes Patient Enrollment for AK138D1 Phase I Study
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of its AK138D1 in advanced malignant tumors in Australia. Drug ProfileAK138D1, an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3), features…
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Summit Therapeutics and Pfizer Collaborate on Ivonescimab-ADC Combo for Solid Tumors
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Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for ivonescimab, announced a clinical collaboration with Pfizer (NYSE: PFE) to evaluate the combination of ivonescimab, Akeso’s PD-1/VEGF bispecific antibody (BsAb), with Pfizer’s antibody drug conjugates (ADCs) in multiple solid tumors. Collaboration DetailsUnder the agreement, Summit…
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Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
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Akeso Biopharma Receives Development Payment for PD-L1 Monoclonal Antibody
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China-based Akeso Biopharma (HKG: 9926) has announced receiving a drug collaboration development payment from compatriot firm Kelun Pharmaceutical Research Institute, following the National Medical Products Administration’s (NMPA) approval of its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab last month. Collaboration BackgroundAkeso entered into a collaboration agreement with Kelun…
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Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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BioNTech Acquires Biotheus for $800 Million, Enhancing Oncology Pipeline
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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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National Reimbursement Drug List (NRDL) Negotiations Conclude with Lower Generic Drug Approval Rate
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The National Reimbursement Drug List (NRDL) negotiations for the year have concluded, with less than 50% of the total 162 participating generic name drugs passing the expert review. This approval rate is a decrease compared to 74.2% in 2022 and 63.8% in 2023. The successful drugs included 117 varieties from…
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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
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Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
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On October 17, ClinicalTrials.gov reported that Akeso Biopharma (HKG: 9926) has initiated a Phase Ib/II clinical study to evaluate the combination of Cadonilimab (CTLA-4/PD-1 dual antibody) and AK112 (Envafolimab, a PD-1/VEGF dual antibody) with chemotherapy as a first-line treatment for pancreatic cancer. The primary endpoints of the study include safety,…
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Akeso Biopharma Secures USD 250 Million in Share Placement, Bolstering Drug Development War chest
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has declared the successful completion of a share placement that has raised USD 250 million. This capital raise has garnered significant attention from international investment firms, with a majority of the final subscribers being long-term and healthcare funds. With this…
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Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
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On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
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Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
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Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
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Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
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Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
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Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
