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Prenetics Acquires Majority Stake in ACT Genomics to Boost Oncology Services
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Hong Kong-based Prenetics Global Ltd (NASDAQ: PRE) has announced the acquisition of a majority stake in Taiwan-based ACT Genomics Holdings Co., Ltd, aiming to establish a powerhouse Asia-based genomics and precision oncology firm. The transaction involves a USD 20 million cash payment and the issuance of 19.9 million common Prenetics…
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CStone’s Sugemalimab MAA Accepted by UK MHRA for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab in combination with chemotherapy as a first-line treatment of patients with metastatic non-small cell lung…
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Ascletis Pharma Receives USPTO Notice for ASC10 Patent
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent application of oral viral polymerase inhibitor ASC10 and its derivatives, and their uses to treat multiple virus infections including SARS-CoV-2, monkeypox virus, and respiratory syncytial…
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HutchMed Initiates Rolling NDA Submission for Elunate to US FDA
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling submission of a New Drug Application (NDA) to the US FDA for Elunate (fruquintinib) for the treatment of refractory metastatic colorectal cancer (CRC). HutchMed plans to complete the NDA submission in the first half of…
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PCAOB Report Signals Relief for US-Listed Chinese Biotechs
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A report issued last week by the US Public Company Accounting Oversight Board (PCAOB) indicated that the threat of forced delisting for non-compliance has been lifted for US-listed Chinese biotechs. The PCAOB, acting under the remit of the US Holding Foreign Companies Accountable Act (HFCAA), reported that it has successfully…
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Luye Pharma’s Shandong Boan Biotechnology IPOs on Hong Kong Stock Exchange
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd has officially made an initial public offering (IPO) of 10.69 million shares to the Hong Kong Stock Exchange, priced at HKD 19.8 (USD 2.54) per share. This amounts to an HKD 212 million (USD 27.2 million) windfall…
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Simcere Pharmaceutical Completes Enrollment for SIM0417 COVID-19 Drug Trial
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of enrollment of 1,208 patients in a Phase II/III clinical study for its SIM0417, an oral COVID-19 drug candidate being co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. Study…
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Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
