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Boehringer Ingelheim Appeals CNIPA’s Invalidation of Jardiance Patents
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The Intellectual Property Court of the Supreme People’s Court of China issued a notice, holding a hearing on the case of administrative dispute over the invalidity of invention patent between the appellant Boehringer Ingelheim and the appellee China National Intellectual Property Administration (CNIPA), as well as third parties of first…
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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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Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the…
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Kexing and Kelun Partner to Expand Overseas Business for Generic Drugs and Therapies
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China-based firms Kexing Pharmaceutical (SHA: 688136) and Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) have agreed to collaborate on the overseas business development of Kelun’s high-end generic drugs and innovative therapies. The partnership aims to leverage the strengths of both companies to expand their global footprint. Agreement DetailsUnder the terms…
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10th National VBP Round Results Announced: Contracts Worth Over RMB1.3 Billion
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The national Volume-Based Procurement (VBP) authorities have released comprehensive details regarding the 10th VBP round, including volumes and regions awarded to winning bidders. According to Fineline Info & Tech‘s calculations, the full round, covering 196 companies with winning bids, was valued at over RMB1.3 billion (USD 178 million) in contracts.…
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National VBP Program Round 10: 195 Manufacturers Secure Winning Bids for 62 Drugs
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The preliminary outcomes of the 10th round of China’s national volume-based procurement (VBP) program were released, with a total of 195 drug manufacturers securing tender spots for 62 different drug products. There were no failed tenders in this round, and the official results are anticipated to be announced after December…
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Sichuan Kelun Pharmaceutical’s H1 2024 Report Highlights MSD Collaboration Milestones
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CHENGDU—Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has released its financial report for the first half of 2024, detailing significant updates on its collaboration with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK). The partnership, focused on the co-development of antibody drug conjugates (ADCs), has seen substantial progress…
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Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
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Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
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Sichuan Kelun Pharmaceutical Reports 12.69% YOY Revenue Growth in 2023 Financial Results
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a leading pharmaceutical company in China, has announced its financial results for 2023, with revenues reaching RMB 21.454 billion (USD 2.96 billion), marking a 12.69% year-on-year (YOY) increase, and a net profit of RMB 2.457 billion (USD 340 million). The company’s research and…
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Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive…
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CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
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Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
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MSD Cancels Development of Two Pre-Clinical ADCs from Sichuan Kelun-Biotech
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) have announced that their US partner Merck, Sharp & Dohme (MSD; NYSE: MRK) has decided to cancel the development of one pre-clinical antibody drug conjugate (ADC) and will not…
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Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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Sichuan Kelun Pharmaceutical Secures Exclusive Rights to TBM-001 for Bone Metastasis Diagnosis
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has entered into an exclusive licensing agreement with the Affiliated Hospital of Southwest Medical University. The agreement pertains to TBM-001, a radionuclide drug conjugate (RDC) designed for early diagnosis and…
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Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced a market approval filing for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (NYSE: MRK/BMS, NYSE: BMY) cetuximab, known under the trade name Erbitux. The…
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Sichuan Kelun-Biotech Biopharmaceutical Prices IPO at HKD 60.6 to 72.8 per Share
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has priced its initial public offering (IPO) filing to the Hong Kong Stock Exchange at a range of HKD 60.6 to 72.8 per share. At an assumed offering price of HKD 60.60…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
