NMPA

OrbusNeich's Joint Venture Kicks Off TricValve Clinical Trial in Mainland China

Retrieved on: 
Mittwoch, April 24, 2024
Tricuspid valve, FDA, TMVR, Hope, Hospital, Percutaneous coronary intervention, NMPA, Safety, Valvular heart disease, OrbusNeich, PCI, TAVR, Patient, PTA, Zhongshan Hospital, Fudan University, Cardiology, Aortic stenosis, Clinical trial, Quality of life, Medical device

The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.

Key Points: 
  • The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.
  • It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.
  • Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve.
  • Mr. Peter Peh, General Manager of OrbusNeich P&F, said, "We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation.

Fosun's Next Step: "Deep Mining" for Stable Profits

Retrieved on: 
Donnerstag, März 28, 2024
Cell, World Health Organization, NMPA, Club Med, Growth, DLBC, Fashion Group International, Mining, KOD, Breast cancer, Gene, National Medical Products Administration, Tourism, Snow, Happiness, Leonardo da Vinci, HKEX, SCLC, Research, Marketing, Fosun Pharma, Lithium, Ice, FTG, Carcinoma, European, Patient, Artesunate, Letter, COVID-19, Fine chemical

With the implementation of the business streamlining strategy, Fosun divested some non-core businesses that had previously provided stable cash flows.

Key Points: 
  • With the implementation of the business streamlining strategy, Fosun divested some non-core businesses that had previously provided stable cash flows.
  • The subsequent improvement in cash flow has brought market attention to how Fosun will sustain stable profit growth as it did over the past decade.
  • The results announcement shows that Fosun's focus on its core businesses in the household consumption sector has gradually yielded results.
  • Leveraging on the two core growth drivers of innovation and globalization, Fosun has continued to deepen its efforts in advantageous industries and reap more stable profits.

Ocean Drive Plastic Surgery's Dr. Alan Durkin to Present Clinical Research on Bellafill at the 12th Chinese Annual Meeting of Minimally-Invasive Aesthetic Medicine

Retrieved on: 
Mittwoch, Mai 8, 2024
Education, Patient, NMPA, National Medical Products Administration, Day, Drive, MD, Conference, Knowledge, Plastic

Dr. Durkin will showcase his vast clinical expertise with Bellafill, symbolizing a monumental milestone for both Suneva and the global aesthetic industry.

Key Points: 
  • Dr. Durkin will showcase his vast clinical expertise with Bellafill, symbolizing a monumental milestone for both Suneva and the global aesthetic industry.
  • Suneva's journey to introduce Bellafill to the Chinese market has been marked by dedication and commitment.
  • After an extensive five-year process, Suneva received approval from the National Medical Products Administration (NMPA) in China on January 17, 2024.
  • With over sixty peer-reviewed articles and six book chapters on aesthetic medicine and surgery, Dr. Durkin's expertise will undoubtedly enrich the discourse at the MIAM conference.

Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates

Retrieved on: 
Mittwoch, Mai 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FDA, Pfizer, Investment, NMPA, Pancreatic cancer, Schizophrenia, ASCO, HKT, Ovarian cancer, AstraZeneca, ELCC, Lung cancer, METIS, Food, CER, Genmab, Roche, GIST, CABP, Psoriasis, BLA, Bristol Myers Squibb, NSCLC, Psychosis, HKEX, NRDL, Safety, SCLC, Research and development, ABSSSI, Marketing, BMS, Clinical trial, Bronchopneumonia, GMG, TED, KarXT, Nivolumab, NDA, Stromal cell, MAA, Carcinoma, Administration, ADS, Patient, Society, Annual general meeting, Sanofi, Growth, Pharmaceutical industry

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates.

Key Points: 
  • Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates.
  • “Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab.
  • In March 2024, Zai Lab presented findings from preclinical studies highlighting the therapeutic potential of ZL-1310 at the European Lung Cancer Congress (ELCC) 2024.
  • Zai Lab to initiate a global Phase 2 study in mild-to-moderate chronic plaque psoriasis in the second quarter of 2024.

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
Mittwoch, Mai 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Henlius Trastuzumab Receives FDA Approval in the United States

Retrieved on: 
Montag, April 29, 2024
FDA, NMPA, National Medical Products Administration, European Commission, Biosimilar, European, Patient, Intas Pharmaceuticals, Civil service commission

SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.

Key Points: 
  • SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
  • The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.
  • To date, HLX02 has benefited more than 180,000 patients.

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

Retrieved on: 
Donnerstag, April 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Retrieved on: 
Donnerstag, April 25, 2024
FDA, Annual, Pharmacy, NMPA, Private, Partnership, CDE, PDUFA, CEPS, European Medicines Agency, News, Annual report, Intangibles, DMD, U.S. FDA, Catalyst Pharmaceuticals, Tax, CHF, MHRA, Duchenne muscular dystrophy, Quality of life, Leber's hereditary optic neuropathy, Vamorolone, BST, Public, EMA, Marketing, File, Sale, Medication, Treasury, NDA, Health care, Duchenne, Bond, Patient, Bank statement, AGM, Growth, Cryptocurrency

As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.

Key Points: 
  • As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.
  • Financially, Santhera reported a 2023 revenue of CHF 103.4 million and net income of CHF 54.8 million, driven by the Catalyst licensing deal.
  • After closing of the transaction in July 2023, Santhera received an upfront payment of USD 90 million (USD 75 million in cash and USD 15 million equity investment).
  • SIX Exchange Regulation has permitted Santhera to publish its 2023 Annual Report by May 31, 2024, at the latest.

China Medical System: New Drug Application of Desidustat Tablets Accepted in China

Retrieved on: 
Dienstag, April 23, 2024
CMS, Tablet, Desidustat, NMPA, NDA, National Medical Products Administration, Kidney failure, New Drug Application, Erythropoiesis, Anemia, Chronic kidney disease, CKD, Week, Patient, Dialysis, Prevalence, Marketing, Diagnosis, Advertising, EPO, Medical device

Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adult chronic kidney disease patients.

Key Points: 
  • Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adult chronic kidney disease patients.
  • The primary endpoint has indicated that Desidustat is more effective than placebo in increasing Hb level.
  • China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets  (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).
  • Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

Bionano and Diagens Sign Partnership to Commercialize the First Ever Clinical Cytogenetic Analysis that Combines OGM and Artificial Intelligence

Retrieved on: 
Mittwoch, April 17, 2024
Cytogenetics, Pregnancy, NMPA, OGM, Partnership, OEM, Doctor of Philosophy, Research, Artificial intelligence, Karyotype, Fertilisation, Genomics, Bone marrow, SVS, SAN, Medical device

Bionano, a global leader in the transformation of the cytogenetic workflow with optical genome mapping (OGM), has entered into a strategic partnership with Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), the pioneering leader in artificial intelligence (AI) chromosome karyotype analysis technology.

Key Points: 
  • Bionano, a global leader in the transformation of the cytogenetic workflow with optical genome mapping (OGM), has entered into a strategic partnership with Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), the pioneering leader in artificial intelligence (AI) chromosome karyotype analysis technology.
  • Diagens has received Class I registration and approval for Bionano’s OGM reagents from China's NMPA and will register the Saphyr™ instrument with NMPA for clinical use in reproductive health.
  • “As a pioneer in AI chromosome karyotype analysis, we are very happy to establish a partnership with Bionano and to jointly explore the reproductive health market.
  • Diagens offers cutting-edge AI technology to help our customers to achieve a better overall success rate of in vitro fertilization.