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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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Sichuan Kelun-Biotech Reports 32.2% Revenue Growth in 2024 H1, Driven by MSD Partnership
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
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Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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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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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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Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
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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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Sichuan Kelun Pharmaceutical’s RET Inhibitor A400 Earns FDA Orphan Drug Designation
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its RET inhibitor A400/EP0031 in the treatment…
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Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
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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-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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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…
