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Luzhu Bio Files for Hong Kong IPO After RMB 4.42 Billion Valuation
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Beijing Luzhu Biotechnology Co., Ltd, a leading developer of human vaccines and therapeutic biologics, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with CICC as the sponsor. The Chinese firm previously secured a Series C financing round that valued the company at RMB 4.42…
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Youwe Bio’s Series B Financing to Advance Microneedle Technology Commercialization
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China-based Youwe (Zhuhai) Biotechnology Co., Ltd, a developer of soluble microneedle transdermal drug delivery technology, has reportedly raised close to RMB 100 million (USD 14.9 million) in a Series B financing round. Cenova Ventures was the sole investor. The proceeds will be used for the commercialization of soluble microneedle technology…
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NHSA Updates NRDL with Focus on Expert Review and Simplified Renewals
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The National Healthcare Security Administration (NHSA) has released the “2022 National Reimbursement Drug List (NRDL) Adjustment Work Plan” along with relevant documents. This official update to the draft proposal issued on June 13th outlines the full details and processes for this year’s NRDL update. List Adjustment ScopeThe scope of the…
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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
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Gritgen Therapeutics Secures Hundreds of Millions in A-Round Financing for Gene Therapy Pipeline
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Gritgen Therapeutics, a leading gene therapy drug developer based in Suzhou, has announced the successful completion of a A-round financing round worth several hundred million yuan. The financing was led by Sequoia China, with participation from Sunlight Insurance, Qingsong Capital, and Beijing Life Science Park Venture Fund. Existing shareholders including…
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Shenzhen-Based Pregbio Raises Funds for Non-Invasive Prenatal Gene Detection
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Pregbio, a Shenzhen-based non-invasive prenatal gene detection company, has reportedly raised an undisclosed amount of money in an angel financing round. The sole contributor to the round was ASB Ventures. The proceeds will be used to promote early screening and diagnosis of preterm labor and pre-eclampsia, non-invasive prenatal screening, and…
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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
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Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
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Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
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Exegenesis Bio Secures Multi-Million Dollar Series B Financing for Gene Therapy Pipeline
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Exegenesis Bio Inc., a leading gene therapy company, has successfully completed a Series B financing round, raising tens of millions of dollars. The round was led by Legend Capital, with Boyuan Capital, Taikang Capital, and previous investors Xianfeng Qiyun and Kaitong Capital participating. The funds raised will be directed towards…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
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Asymchem Laboratories Secures RMB 2.31 Billion Private Placement with Hill House Capital Subscription
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Asymchem Laboratories (Tianjin) Co., Ltd, a renowned Contract Development and Manufacturing Organization (CDMO) based in China and listed on the SZSE under the ticker (002821), has unveiled a significant private placement initiative. The company will issue 18,700,000 A shares at a price of RMB 123.56 per share. Hill House Capital,…
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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 (HKG: 1801), 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)…
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Luye Pharma Expands Latin American Reach with Exclusive Seroquel Promotion Agreement in Brazil and Mexico
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Luye Pharma Group (HKG: 2186), a leading Chinese pharmaceutical conglomerate, has declared that its wholly-owned subsidiary, Luye Hong Kong Limited, has secured an exclusive promotion agreement with two subsidiaries of US-based Moksha8 Pharmaceuticals, Moksha8 Brasil Distribuidora e Representação de Medicamentos Ltda. and Moksha8 Farmacéutica, S. de R.L. de C.V. This…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
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Enhancing Clinical Trial Success: CDE’s New Adaptive Design Framework Opens for Comment
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The newly proposed guidelines are designed to be applicable across a spectrum of confirmatory clinical studies, encompassing chemical drugs, biological products, and traditional Chinese medicine (TCM). They also hold significant value for exploratory research endeavors. Adopting an adaptive design should be predicated on considerations of rationality, integrity, and feasibility. The…
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Thermo Fisher Scientific Develops Serology Test to Detect COVID-19 Antibodies in Collaboration with WuXi Diagnostics and Mayo Clinic
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Thermo Fisher Scientific Inc., a titan in the US device industry and listed on the NYSE under the ticker (TMO), has unveiled the development of a serology test designed to detect the SARS-CoV-2 coronavirus. This collaborative effort with China’s WuXi Diagnostics and the prestigious US medical institution, Mayo Clinic, is…
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Cuban-Chinese Pharma Synergy: Joint R&D and Sales Initiative Targets USD 24.53 Billion in Sales
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In a significant move to bolster its innovation pipeline, Guangzhou Pharmaceutical Holdings Ltd. has entered into a letter of intent with BioCubaFarma, Cuba’s leading state-owned pharmaceutical company. This strategic alliance is aimed at joint research and development (R&D), manufacturing, and sales of cutting-edge pharmaceutical products in China, with a particular…
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Guangzhou Pharma and BioCubaFarma Chart New Course with Joint Biologics R&D and Exchange Deal
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Guangzhou Pharmaceutical Holdings Ltd., a prominent player in China’s pharmaceutical sector, has inked a strategic letter of intent with BioCubaFarma, Cuba’s foremost state-owned pharmaceutical juggernaut, to embark on a joint venture in research and development (R&D), manufacturing, and commercialization of avant-garde pharmaceutical products within the Chinese market, with a spotlight…
