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Novatim Immune Therapeutics’ KQ-2003 Gains Tacit Approval for POEMS Syndrome Clinical Trial in China
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Novatim Immune Therapeutics (Zhejiang) Co., Ltd, a China-based specialist in cancer immunotherapy, has received tacit clinical trial approval from Chinese regulatory authorities for its investigational therapy, KQ-2003. This autologous chimeric antigen receptor (CAR)-T cell therapy targets BCMA and CD19 and is poised to be evaluated for the treatment of recurrent/refractory…
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Harbour BioMed Reports Triple-Digit Revenue Growth and First-Ever Net Profit in 2023 Financial Results
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with a global presence in Suzhou, China, Cambridge in the US, has announced its financial results for the full year of 2023. The company reported a significant leap in revenues, reaching USD 89.5 million, which marks an increase of 119.9% year-on-year (YOY). In…
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Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China, has announced that it has received marketing approval from New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) for its enoxaparin sodium injection, which will be marketed under the trade name Exarane. Enoxaparin sodium injection…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
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WuXi AppTec Denies US Allegations of Unauthorized Intellectual Property Transfer
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WuXi AppTec (SHA: 603259, HKG: 2359), a leading Contract Research, Development, and Manufacturing Organization (CRDMO) based in China, has found itself at the center of a controversy following allegations by US intelligence officials. According to a Reuters report, these officials claimed that WuXi AppTec had transferred a client’s intellectual property…
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China’s National Joint Procurement Office Announces Renewal of Insulin Procurement Contracts Valued at $1.59 Billion
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The National Joint Procurement Office in China has announced the renewal of drug procurement contracts for insulin products under the volume-based procurement (VBP) program, with the renewal process scheduled for April 23, 2024. The procurement cycle is valued at RMB 11.5 billion (approximately USD 1.59 billion), and the winning bids…
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FDA Reviews Eisai’s Leqembi for Expanded Use as Monthly Alzheimer’s Therapy
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The US Food and Drug Administration (FDA) has given the green light to review an indication extension filing for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy developed by Japanese pharmaceutical company Eisai Co., Ltd. (TYO: 4523). Currently, Leqembi has conditional approval in Japan as a bi-weekly treatment for Alzheimer’s disease (AD)…
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WuXi AppTec Denies Unauthorized IP Transfer Allegations Amidst Strong Financial Performance
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WuXi AppTec (SHA: 603259, HKG: 2359), a China-based Contract Research, Development, and Manufacturing Organization (CRDMO) , faced allegations this week that could potentially impact its international reputation. According to a Reuters report, US intelligence officials have accused the company of transferring a client’s intellectual property to Beijing without authorization. The…