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Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
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Innovent Biologics Halts Subscription Agreement with Lostrancos Ventures
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the decision not to proceed with a subscription agreement between its wholly owned subsidiary, Fortvita, and Lostrancos Ventures Ltd. The agreement would have seen Lostrancos acquire a 20% stake in Fortvita for USD 20.5 million. Despite this setback, Innovent Biologics reaffirmed its…
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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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Innovent Biologics Reports Q3 2024 Sales Exceeding RMB 2.3 Billion, Up 40% YOY
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China-based Innovent Biologics Inc., (HKG: 1801) has announced product sales exceeding RMB 2.3 billion (USD 323 million) for the third quarter of 2024, marking a 40% year-on-year (YOY) increase. The company’s competitive edge in China is attributed to its product indication expansion, extensive coverage on the National Reimbursement Drug List,…
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Innovent’s Fortvita Stake Sale Sparks Controversy, Shares Plummet Nearly 13%
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Innovent Biologics, Inc. (HKG: 1801), headquartered in China, has announced a subscription agreement in which its wholly owned subsidiary Fortvita will sell a 20% stake to Lostrancos Ventures Ltd. for USD 20.5 million. This news has sparked market controversy, with some investors criticizing the valuation of Fortvita as being too…
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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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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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Innovent Biologics and ASK Pharma Forge Strategic Partnership for Limertinib in Lung Cancer Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
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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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Innovent Biologics Launches Phase I Clinical Trial for IBR822 Cell Injection Solution in Solid Tumors
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Innovent Biologics (Hangzhou) Co., Ltd (HKG: 1801, OTCMKTS: IVBXF), a biopharmaceutical company based in China, has announced the successful initiation of a Phase I clinical trial for its proprietary IBR822 cell injection solution at Zhejiang Cancer Hospital. The trial, led by Professor Song Zhengbo from Zhejiang Cancer Hospital, is conducted…
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Innovent Biologics’ Mazdutide Outperforms Dulaglutide in Phase III T2D Study at EASD Meeting
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Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
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Innovent Biologics Presents Promising Phase I Data for IBI363 in Advanced NSCLC at WCLC
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
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Innovent Biologics’ Dupert Demonstrates Positive Results in Phase II NSCLC Trial
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment…
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Innovent Biologics’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, IBI363. This PD-1/IL-2α bispecific antibody fusion protein is under development for the treatment of unresectable locally advanced or metastatic melanoma, excluding…
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Innovent Biologics Reports 46.3% YOY Revenue Growth and Expands Portfolio with New Approvals and NDAs
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Innovent Biologics, Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced its interim results for 2024 along with significant business updates. The company reported a robust year-over-year (YOY) growth in total revenue, which stood at RMB 3,952.3 million, marking…
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Innovent Biologics’ President Liu Yongjun Resigns, CEO De-Chao Micheal Yu Takes R&D Reins
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Innovent Biologics Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has reportedly seen the resignation and retirement of its president, Liu Yongjun. The company’s research and development initiatives are now under the leadership of Innovent’s founder, chairman, and CEO, De-Chao…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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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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Innovent Biologics Reports Over RMB 2 Billion in Q2 2024 Sales, Highlighting 50% YOY Growth
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has reported a significant surge in product sales for the second quarter of 2024, exceeding RMB 2 billion (USD 279 million), marking a 50% year-on-year (YOY) increase. The company’s strong market presence in China is attributed to its extensive…
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Innovent Biologics and Sanegene Bio Commence Phase I Clinical Trial for Hypertension siRNA Drug
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
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Innovent Biologics’ Mazdutide NDA for Type 2 Diabetes Accepted for Review in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review the second New Drug Application (NDA) for its investigational drug mazdutide (IBI362). Mazdutide is a novel glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR)…
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Innovent Biologics Partners with Wecomput Technology to Accelerate AI in Drug Development
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Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has entered into a strategic partnership with Wecomput Technology Co., Ltd, a prominent computational contract research organization (CRO) in China with a global footprint. The collaboration aims to harness the power of artificial intelligence (AI) to enhance…
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IASO Biotechnology’s CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotechnology has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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Innovent Biologics’ Mazdutide Achieves Primary and Secondary Endpoints in Phase III T2D Trial
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Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese…
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Suzhou Sanegene Bio Receives NMPA Approval for Clinical Trial of Antihypertensive siRNA Drug
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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Ascentage Pharma’s Olverembatinib Receives Marketing Approval from Macau SAR for CML Treatment
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
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Innovent Biologics and IASO Biotechnology Amend Partnership, Focusing on CAR-T Therapy Fucaso
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced a new set of agreements with IASO Biotechnology, a domestic firm, to adjust the terms of their earlier partnership. According to the new deals, IASO will acquire from Innovent its rights to the BCMA-targeted chimeric antigen…
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Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
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Innovent Biologics’ Mazdutide Shows Promise in Phase III Obesity Trial
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Innovent Biologics Inc. (HKG: 1801), a biopharmaceutical company based in China, has announced the presentation of key results from the first Phase III clinical trial of mazdutide in Chinese adults with overweight or obesity at the ADA Scientific Sessions 2024. The trial, known as GLORY-1 (NCT05607680), is a multi-center, randomized,…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
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Innovent Biologics Presents Clinical Data for Pipeline Candidates at ASCO 2024
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful completion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The drug, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all primary and key secondary endpoints in the Phase III…
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Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful conclusion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection has met all primary and key secondary endpoints in the Phase III registrational study…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
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Innovent Biologics’ Mazdutide Shows Superiority in Type 2 Diabetes Phase III Trial
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase III DREAMS-2 study for mazdutide (IBI362), a dual agonist targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), has met its primary endpoint in Chinese subjects with type 2 diabetes (T2D). The…
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Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Innovent Biologics Reports 36.2% Revenue Growth in 2023, Highlights Robust Product Sales
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Innovent Biologics Inc. (HKG: 1801), a China-based biotechnology firm, has released its 2023 financial report, revealing a robust revenue growth of 36.2% year-on-year (YOY) to RMB 6.21 billion (USD 862 million). Product sales constituted RMB 5.73 billion (USD 796 million), marking a 38.4% YOY increase. Despite reporting a loss of…
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Innovent Biologics Denies Lab Closure, Confirms Relocation to California
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Innovent Biologics (HKG: 1801) has refuted unconfirmed reports regarding the closure of its Rockville, Maryland lab, stating instead that the facility is being relocated to California. The clarification follows a report by Yicai, which indicated potential downsizing at the Maryland site. However, Innovent has not disclosed a timeline for the…
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Innovent Biologics Allegedly Closes US Research Facility, Shifts Focus to China
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Innovent Biologics (HKG: 1801), a China-based biotech firm, has reportedly closed down a research team at its US headquarters in Rockville, Maryland, according to BioSpace. The wet lab facility is anticipated to be fully shut down in the near future. While Innovent has not issued an official statement regarding these…
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Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
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China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
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Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently…
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Innovent Biologics Launches Phase I Study for IBI3002, a Bispecific Antibody Targeting Asthma
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Innovent Biologics, Inc. (HKG: 1801), based in China, has announced the initiation of its Phase I clinical study for IBI3002, a pioneering bispecific antibody designed to target Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). This innovative therapy aims to address asthma and other type 2 inflammatory diseases…
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Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
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Innovent Biologics Partners with ImmVirX to Launch Clinical Study Combining Tyvyt and IVX037
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Innovent Biologics Inc. (HKG: 1801), based in China, has announced the signing of a clinical study and supply cooperation agreement with ImmVirX Pty Ltd. This strategic partnership will facilitate a clinical study that combines Innovent’s Tyvyt (sintilimab), a programmed death-1 (PD-1) inhibitor already approved in China for seven different indications,…
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Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application…
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Innovent Biologics Posts 65% YOY Growth in Q4 2023 with Over RMB 1.6 Billion in Sales
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Chinese biopharmaceutical company Innovent Biologics Inc., (HKG: 1801) has reported impressive quarterly sales figures, announcing over RMB 1.6 billion (USD 219 million) in product sales for Q4 2023, marking a 65% year-on-year (YOY) increase. In the final quarter of the year, Innovent’s PD-1 inhibitor, Tyvyt (sintilimab injection), maintained strong market…
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Innovent Biologics’ Mazdutide Achieves Positive Results in Phase III Clinical Trial for Overweight or Obesity
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the first Phase III clinical study for mazdutide (IBI362), a dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has successfully met its primary endpoints and all key secondary endpoints…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity Treatment
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Innovent Biologics Inc., a biopharmaceutical company based in China (HKG: 1801), has announced the first patient dosing in the Phase III GLORY-2 study, which is assessing the higher dose 9mg version of mazdutide (IBI362) for the treatment of obesity in Chinese adults. Mazdutide is a dual agonist drug candidate targeting…
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Innovent Biologics Partners with Xuanzhu Biopharma for Clinical Trial of Sintilimab and KM-501 in Advanced Tumors
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Innovent Biologics, Inc. (HKG: 1801), based in China, has entered into a clinical trial collaboration and supply agreement with Xuanzhu Biopharma to explore the combination therapy of Tyvyt (sintilimab) with KM-501, a novel HER-2 bispecific antibody drug conjugate (ADC). This partnership aims to develop potential treatment options for advanced solid…
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Innovent Biologics Partners with Sanegene Bio USA to Develop Hypertension Drug
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China-based Innovent Biologics (HKG: 1801) has entered into a partnership with Sanegene Bio USA Inc. to co-develop the small interfering RNA (siRNA) candidate drug SGB-3908 for the treatment of hypertension. Innovent Biologics has secured the exclusive option to license global development, manufacturing, and commercialization rights for the drug. Upon the…
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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
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Innovent Biologics Expands Partnership with Synaffix for New ADC Development
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Innovent Biologics Inc. (HKG: 1801) has announced an expanded partnership with U.S.-based Synaffix B.V., a subsidiary of Lonza (SWX: LONN). This follows an initial agreement from June 2021, during which Innovent successfully utilized Synaffix’s antibody-drug conjugate (ADC) technology platforms on a non-exclusive basis to develop IBI343, an anti-CLDN18.2 ADC that…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
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Innovent Biologics Presents Positive Clinical Results for Efdamrofusp Alfa and IBI324 at AAO
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Innovent Biologics, Inc. (HKG: 1801), a China-based biopharmaceutical company, has published the latest clinical results for its two drug candidates, efdamrofusp alfa (IBI302) and IBI324, at the American Association of Ophthalmology (AAO) meeting. IBI302 is a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein, while IBI324 is a bispecific…
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Innovent Biologics Reports Q3 2023 Sales Exceeding RMB 1.6 Billion with 45% YOY Growth
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced its product sales for Q3 2023, which exceeded RMB 1.6 billion (USD 219 million), marking a 45% increase year-on-year (YOY). The company’s PD-1 inhibitor, Tyvyt (sintilimab injection), continued to show strong market performance, and there was…
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Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
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Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
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Innovent Biologics’ Mazdutide Shows Promising Weight Loss Results in Phase II Trial
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China-based Innovent Biologics Inc., (HKG: 1801) has revealed compelling Phase II data for its weight loss drug candidate, mazdutide (IBI362), after 48 weeks of treatment. The higher dose (9mg) of mazdutide demonstrated significant efficacy in achieving weight loss among Chinese subjects with obesity, alongside favorable safety profiles and multiple metabolic…
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Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
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The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
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Innovent Biologics Doses First Patient in Phase 3 Study of IBI302 for Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302). This recombinant fully human anti-VEGF and anti-complement bispecific fusion protein aims to address unmet needs in nAMD…
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Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
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Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
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Innovent Biologics Plans Share Placement to Raise HKD 2.36 Billion for Global Expansion
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China-based biotech Innovent Biologics Inc., (HKG: 1801) has issued a notice stating its intention to release 68 million shares priced at HKD 38.30 (USD 4.90), offering an 8.8% discount to the September 11, 2023, closing price. Morgan Stanley is acting as the agent for the placement, responsible for securing purchasers…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKEX: 01801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
