NMPA

Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis

Retrieved on: 
Monday, February 26, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Week, UPCR, HKEX, CRR, Safety, Patient, Lupus nephritis, Clinical trial, CDE, IND, KZR, NMPA, Kidney failure, Pharmaceutical industry

Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).

Key Points: 
  • Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).
  • Everest will join Kezar and enroll patients in China as part of the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib or placebo in patients with active LN.
  • In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia.
  • “With the approval of the zetomipzomib IND in China, Everest now has three medicines in the renal space either commercialized or in clinical development.

Leading Cervical Cancer Doctors Support Approval of LuViva in China Based on Preliminary Review of Clinical Trial Results

Retrieved on: 
Tuesday, February 20, 2024
Other Health, Research, General Health, Oncology, Consumer, Medical Devices, Clinical Trials, Science, Women, Biotechnology, Medical Supplies, Health, OTCQB, Hospital, Cervical cancer, Fudan University, SMI, Physician, Shandong University, Chinese, Therapy, Statistics, NMPA, Pharmaceutical industry

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that a group of prominent cervical cancer doctors are in the final stages of completing the clinical data report that will be submitted for approval by the Chinese National Medical Products Administration (NMPA).

Key Points: 
  • Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that a group of prominent cervical cancer doctors are in the final stages of completing the clinical data report that will be submitted for approval by the Chinese National Medical Products Administration (NMPA).
  • The data quality assurance review team is being led by Dr. Sui Long, Director of the Gynecology Hospital at Fudan University and includes physicians from Qilu Hospital at Shandong University and two hospitals in Shanghai.
  • The quality assured data report is expected by the end of this month with final statistics from the study to be available early in March.
  • SMI’s CEO, Mr. Yaohua Li reported that “We already have pre-orders from multiple provinces in China for nearly 100 devices and thousands of disposables.

Hybribio Calls for Raising International HPV Awareness

Retrieved on: 
Monday, March 4, 2024
International, Hospital, Cervical cancer, Woman, IPVS, SOX1, Methylation, Cancer, Human papillomavirus infection, Wart, Vaccination, World Health Organization, Fluorescence, Organization, HPV, Vagina, WHO, PCR, NMPA

On this special day, Hybribio (300639.SZ) calls for raising international HPV awareness and adopting effective strategies for early detection and prevention.

Key Points: 
  • On this special day, Hybribio (300639.SZ) calls for raising international HPV awareness and adopting effective strategies for early detection and prevention.
  • In this case, raising HPV awareness, getting timely vaccination and high-quality screening together contribute significantly to the prevention of HPV infection and related diseases.
  • Hybribio has developed a complete HPV molecular diagnostic solution covering 14 High-risk HPV GenoArray Diagnostic Kit, 14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit, 14 High-risk HPV E6/E7 mRNA Real-time PCR Kit (PCR with Fluorescent Probe), 21 HPV GenoArray Diagnostic Kit, 37 HPV GenoArray Diagnostic Kit, 13 High-risk HPV Real-time PCR Kit, 23 HPV Genotyping Real-time PCR Kit, SOX1 and PAX1 Methylation Real-time PCR Kit.
  • Raising international HPV awareness is the very first step against cervical cancer.

Hybribio Calls for Raising International HPV Awareness

Retrieved on: 
Monday, March 4, 2024
International, Hospital, Cervical cancer, Woman, IPVS, SOX1, Methylation, Cancer, Human papillomavirus infection, Wart, Vaccination, World Health Organization, Fluorescence, Organization, HPV, Vagina, WHO, PCR, NMPA

On this special day, Hybribio (300639.SZ) calls for raising international HPV awareness and adopting effective strategies for early detection and prevention.

Key Points: 
  • On this special day, Hybribio (300639.SZ) calls for raising international HPV awareness and adopting effective strategies for early detection and prevention.
  • In this case, raising HPV awareness, getting timely vaccination and high-quality screening together contribute significantly to the prevention of HPV infection and related diseases.
  • Hybribio has developed a complete HPV molecular diagnostic solution covering 14 High-risk HPV GenoArray Diagnostic Kit, 14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit, 14 High-risk HPV E6/E7 mRNA Real-time PCR Kit (PCR with Fluorescent Probe), 21 HPV GenoArray Diagnostic Kit, 37 HPV GenoArray Diagnostic Kit, 13 High-risk HPV Real-time PCR Kit, 23 HPV Genotyping Real-time PCR Kit, SOX1 and PAX1 Methylation Real-time PCR Kit.
  • Raising international HPV awareness is the very first step against cervical cancer.

Calliditas Year-end report, January - December 2023

Retrieved on: 
Wednesday, February 21, 2024
Head, Sustainability, European Commission, Operating cost, Marketing, Food and Drug Administration, USD, National Medical Products Administration, FDA, Food, Risk, MAH, Patent, Patient, Alport syndrome, Trial of the century, NMPA

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

Calliditas Year-end report, January - December 2023

Retrieved on: 
Wednesday, February 21, 2024
Head, Sustainability, European Commission, Operating cost, Marketing, Food and Drug Administration, USD, National Medical Products Administration, FDA, Food, Risk, MAH, Patent, Patient, Alport syndrome, Trial of the century, NMPA

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024
LEGEND, Investigational New Drug, EIB, Data monitoring committee, European Investment Bank, SUSAR, BofA Securities, DMC, Adverse effect, Conference, Autoimmune hepatitis, Observation, Type 2 diabetes, DSM-IV codes, Patient, Fatty liver disease, Acceleration, Clinical trial, NASH, Phase, IND, NMPA, Euronext Paris, Sino Biopharmaceutical Limited, Partnership, Pharmaceutical industry

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Yiviva Announces Memorandum of Understanding with AstraZeneca to Develop Platforms, Technologies, and Innovative Therapeutics through a Systems Biology Approach

Retrieved on: 
Monday, February 5, 2024
Partnership, DCI, Inula racemosa, Convention center, Knowledge, Research, China International Import Expo, Systems biology, Ecosystem, FDA, Biotechnology, Entrepreneurship, AstraZeneca, NMPA, Drug development, MOU, Pharmaceutical industry

The signing ceremony took place at the 2023 China International Import Expo (CIIE) at the National Exhibition and Convention Center in Shanghai.

Key Points: 
  • The signing ceremony took place at the 2023 China International Import Expo (CIIE) at the National Exhibition and Convention Center in Shanghai.
  • “2023 marks the 30th anniversary of AstraZeneca in China.
  • In collaboration with the Chengdu government and Chengdu High-Tech Industrial Zone (CDHT), AstraZeneca is establishing a modern healthcare development platform integrating traditional Chinese medicine and Western medicine.
  • Our strategic partnership with Yiviva, will advance our blueprint for how to develop innovative medicines inspired by Chinese medicine,” remarked Lily Zhu, Vice President of AstraZeneca China and Head of DCI and CSE.

Agilis Robotics Unveils Groundbreaking Advancements in Endoluminal Surgery

Retrieved on: 
Monday, February 5, 2024
Multimedia, Surgeon, Cystoscopy, Robotics, University, CFO, Chapter, System, Patient, Safety, National Medical Products Administration, FDA, Food, NMPA, University of Hong Kong, Food and Drug Administration, Bladder cancer, Learning curve, Gastrointestinal cancer, HKEX, Hospital, Pharmaceutical industry

HONG KONG, Feb. 2, 2024 /PRNewswire/ -- Agilis Robotics, a leading innovator in surgical robotics, is spearheading a paradigm shift in the field of "incisionless" endoluminal surgery.

Key Points: 
  • HONG KONG, Feb. 2, 2024 /PRNewswire/ -- Agilis Robotics, a leading innovator in surgical robotics, is spearheading a paradigm shift in the field of "incisionless" endoluminal surgery.
  • The robotic instruments offer unprecedented possibilities across endoluminal surgery, spanning the upper and lower gastrointestinal (GI) tract, urinary tract, throat, and gynaecology.
  • Agilis Robotics is a spin-off from The University of Hong Kong and has secured more than HKD 90 million in funding from private investors.
  • Furthermore, Agilis Robotics understands the importance of cost-effectiveness, marketability, and market potential, ensuring a successful venture for investors and hospitals.

China Medical System (00867） Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro®

Retrieved on: 
Sunday, February 4, 2024
SP, License, Peritoneal dialysis, Patient, National Medical Products Administration, Ageing, Glomerular filtration rate, CKD, NMPA, HD, Dialysis, CMS, Sale, Chronic kidney disease, PB, PD, Pharmaceutical industry

Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023.

Key Points: 
  • Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023.
  • Upon the expiration of the aforementioned term, the License Agreement may automatically be renewed for ten years as per certain conditions defined in the License Agreement.
  • There is an issued patent that protects the formulation, usage, particle size and manufacturing methods of the Product in China.
  • Velphoro® is a newly approved innovative drug in China in 2023 and has been successfully included in category B of the National Reimbursement Drug List.