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CDE Releases 58th and 59th Batches of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 58th and 59th batches of chemical generic reference preparations, adding 15 and 59 new specifications respectively. The public feedback deadlines for these batches are May 10 and June 30, 2022. Updates and FeedbackThe 58th and 59th batches saw 28 and 32…
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Shenzhen’s LWPOCT Secures RMB 100 Million in Series A Round for CDMO Expansion
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Shenzhen-based medical devices and reagents manufacturer Shenzhen Living Water POCT Co., LTd (LWPOCT) has reportedly secured RMB 100 million in a Series A financing round. The funding was led by Shenzhen Guochuang Zhiyuan Private Equity Fund Management, Shenzhen Ruihai Private Equity Investment Fund Management, VDO Biotech, Shenzhen Qianhai Zhouyu Investment…
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Henlius Biotech Begins Global Phase III Trial for Denosumab Biosimilar HLX14
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first patient dosing in a global multi-center Phase III clinical study for its drug candidate HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab). The study targets the treatment of postmenopausal osteoporosis in women at high risk of fracture. Clinical Trial DesignThe…
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Cellular Biomedicine Group’s C-CAR039 Receives NMPA Approval for B-Cell NHL Study
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China-based Cellular Biomedicine Group Inc. (CBMG), a private company following a merger deal in February last year, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study of its chimeric antigen receptor (CAR)-T cell therapy C-CAR039 in patients with relapsed or refractory…
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Global Cord Blood Corp’s Cellenkos Gets FDA Nod for Myelofibrosis Trial
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Global Cord Blood Corporation (GCBC; NYSE: CO) announced receiving Investigational New Drug (IND) approval from the US FDA for its subsidiary Cellenkos’ pipeline candidate CM0804. The FDA clearance allows Cellenkos to initiate a Phase Ib, open-label study for CM0804 as an add-on therapy to ruxolitinib in patients with myelofibrosis who…
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Hangzhou Tongee Medical Closes RMB 100 Million Series B Round for Gastric Bypass Stent
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Hangzhou Tongee Medical Technology Co., Ltd, a Chinese device maker specializing in metabolic disease treatments, has secured close to RMB 100 million (USD 14.9 million) in a Series B financing round. The funding, led by Topping Capital and Guolian Group, will support a regulatory clinical study for its gastric bypass…
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Walvax’s mRNA Vaccine AWcorna Shows Superior Immune Response in Phase III Trial
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Walvax Biotechnology Co., Ltd’s (SHE: 300142) mRNA vaccine against SARS-CoV-2, named AWcorna, has reached the Phase III stage in multiple trial centers. The randomized trial (ChiCTR2100053701), led by the Academy of Military Medical Sciences and the Guangzhou Institute of Respiratory Health, enrolled 300 adults who had previously received two doses…
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Tianhe-2 Supercomputer Aids Drug Discovery with Deep-Learning Biosynthetic Tool
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China’s Tianhe-2 supercomputer, ranked among the top-10 fastest computers globally, has demonstrated potential in enhancing drug discovery through a Sino-US research collaboration. Scientists from Sun Yat-sen University, Beijing-based AI startup Galixir, and researchers from the Georgia Institute of Technology and the Massachusetts Institute of Technology developed a deep-learning-based toolkit called…
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Shanghai Pharmaceuticals Licenses Benapenem and Plazomicin from Xuanzhu Bio for Greater China
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China-based pharmaceutical giant Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) announced a licensing agreement with compatriot firm Xuanzhu Biopharmaceutical Co., Ltd. Under the terms, Shanghai Pharma secures exclusive rights (including sub-licensing, manufacturing, development, and sales) to Xuanzhu Bio’s benapenem and plazomicin in Greater China (mainland China, Hong Kong, Macau, and Taiwan).…
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Sichuan Meida’s Phentolamine Gains Priority Review for Pheochromocytoma Treatment
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Meida Kangjiale Pharmaceutical Co., Ltd’s phentolamine has obtained priority review status as a “clinically urgent, in-shortage drug.” This non-selective alpha-adrenoceptor antagonist is used to control paroxysmal hypertension in patients with pheochromocytoma before and during surgery. Clinical Application and MechanismPhentolamine is…
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Mabwell’s 6MW3511 Accepted by NMPA for Advanced Solid Tumor Treatment
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that a clinical trial filing for its 6MW3511 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company’s innovative oncology pipeline. Drug Mechanism and Innovation6MW3511 is a bifunctional protein linking an…
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NMPA Approves 164 Medical Devices in May 2022, Including Medtronic and Boston Scientific Products
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The National Medical Products Administration (NMPA) approved a total of 164 medical devices for marketing in May 2022. The approvals included 109 domestic Class III products, 23 imported Class III products, 30 imported Class II products, and 2 products from “special administrative regions.” Notable ApprovalsAmong the approved devices were offerings…
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Boao Lecheng Sees Surge in Drug Use and Medical Tourism Amid Global Partnerships
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The Boao Lecheng Medical Tourism Pilot Zone reported a significant increase in special drug and device users, up 431% year-on-year (YOY) in 2021. Medical tourist numbers surged 90.57% YOY to 127,300, according to China News, with the area welcoming 40,000 medical tourists in Q1 of this year, marking a 60%…
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Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
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Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug Application (NDA) filing for its Obizur (susoctocog alfa) has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for use as an on-demand treatment and prevention of bleeding in…
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Sirnaomics’ STP705 Shows Promising Results in Skin Cancer Trial
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate, STP705, for the treatment of skin cancer, in the May 2022 issue of the Journal of Drugs in Dermatology (the “JDD”). Clinical Trial ResultsThe single-center, open-label, dose-escalation…
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Joincare Pharmaceutical Plans USD 300-400 Million GDR Issue for Global Expansion
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) announced plans to issue Global Depository Receipts (GDRs) on the SIX Swiss Exchange. The proceeds will be used to support international business development and accelerate global expansion. The fundraising size is expected to be in the region of USD 300-400 million,…
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HitGen Inc. Forms Strategic Partnership for New Drug Research and Development
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China-based HitGen Inc. (SHA: 688222) announced the establishment of a strategic partnership with compatriot firm Health Sky Pharmaceutical. The collaboration aims to leverage their respective technology and resource advantages to jointly pursue new drug research and development, pre-clinical and clinical studies, and program incubation. Partnership DetailsHitGen brings to the table…
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Yabao Pharmaceutical’s YBSW015 Gets Australian Ethical Approval for COVID-19 Trial
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received clinical trial ethical approval in Australia to conduct a Phase I clinical study for its YBSW015, a bispecific neutralizing antibody against SARS-CoV-2 developed to treat COVID-19 infection. Mechanism of ActionYBSW015 is a bispecific antibody (BsAb) targeting…
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Suzhou Zelgen’s JAK Inhibitor Jacktinib Gets NMPA Green Light for COVID-19 Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 Janus kinase (JAK) inhibitor, jacktinib, in patients with severe COVID-19. Mechanism of ActionJacktinib works by blocking the signal transducer…
