National Medical Products Administration

CMC Electronics wins contract with KAI

Retrieved on: 
Monday, July 11, 2022
National Medical Products Administration, LAD, Marketing, KF, KAI, CMC, Aircraft, Electronics, CMC Electronics, ROKAF, Multimedia, Technology, Republic of Korea Air Force, Korea Aerospace Industries, KA-1, Growth, Airline

MONTREAL, July 11, 2022 /PRNewswire/ - CMC Electronics (CMC) is pleased to announce that Korea Aerospace Industries (KAI) has awarded a new contract to CMC for the modernization of the Republic of Korea Air Force (ROKAF) fleet of KA-1 trainer aircraft used for advanced mission training and light attack missions.

Key Points: 
  • MONTREAL, July 11, 2022 /PRNewswire/ - CMC Electronics (CMC) is pleased to announce that Korea Aerospace Industries (KAI) has awarded a new contract to CMC for the modernization of the Republic of Korea Air Force (ROKAF) fleet of KA-1 trainer aircraft used for advanced mission training and light attack missions.
  • The PU-3000 software development kit also allows KAI to develop specific proprietary mission applications on their own.
  • "This new contract is a timely and strategic development for all parties involved.
  • commented Mr. Brad Nolen, Vice President, Sales and Marketing at CMC Electronics.

SCG Cell Therapy Announces U.S FDA Clearance of Investigational New Drug Application for SCG101, SCG's Novel TCR-T Cell Therapy For Hepatitis B-related Liver Cancers

Retrieved on: 
Monday, July 11, 2022
Hepatocellular carcinoma, EASL, Serum, HSA, NMPA, FDA, Biotechnology, Disease, ILC, Doctor of Philosophy, Engineering, Food, Investigational New Drug, National Medical Products Administration, IND, Hepatitis B, Food and Drug Administration, MHC, HBsAg, Infection, Hepatitis B virus, Liver cancer, SCG, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TCR, HBV, Epitope, Patient, Helicobacter pylori, Death, HLA, Cancer, HCC, Clinical trial, Antibody, CccDNA, Pharmaceutical industry, Vaccine

SINGAPORE, July 11, 2022 /PRNewswire/ -- Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has clearedthe Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer.

Key Points: 
  • SINGAPORE, July 11, 2022 /PRNewswire/ -- Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has clearedthe Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer.
  • This further establishes SCG101 as the first TCR-T cell therapy product approved for clinical trial across the U.S, China and Singapore.
  • "Clearance of the IND for SCG's leading cell therapy product SCG101 across the United States and Asia is an important milestone for the company," said Frank Wang, Chief Executive Officer of SCG Cell Therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

SinoMab Received the Highest Subsidy from HKSTP

Retrieved on: 
Friday, July 8, 2022
Patient, Heart, Research, Pemphigus vulgaris, NMOSD, Investigational New Drug, Hong Kong Science and Technology Parks Corporation, Growth, Company, Industry, Innovation and Technology Bureau, Mab, IND, Neuromyelitis optica spectrum disorder, National Medical Products Administration, Thirteenth, Twelfth, PV, Therapy, Science park, NMPA, CD22, The Company, RA, B-cell lymphoma, MS, Biotechnology, Electronics, Technology, SLE, ITR, Lupus, Multiple sclerosis, Ecosystem, I&T, Translational research, GBA, CTC, Center for Drug Evaluation and Research, Rheumatoid arthritis, CDE, Trial of the century, SM03, HKSAR, R, BTK, The Group, NHL, Safety, Asthma, HKSTP, Center, Program, Hong Kong Science Park, Pharmaceutical industry, Guangdong-Hong Kong-Macau Greater Bay Area

Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.

Key Points: 
  • Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.
  • SinoMab stood out from many biopharmaceutical companies in the CTC program and was granted the highest subsidy amount, embodying the recognition by the evaluation committee on the Company's product candidates and research and development (R&D) plan.
  • Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "By launching the CTC program, HKSTP provides great support to local biopharmaceutical companies on their New Drug R&D.
  • With the smooth progress of clinical trials of the Company's key candidates, the subsidy from the HKSTP will provide a solid foundation for the Company's continuous R&D and stepping toward commercialization.

 InnoCare Announces Approval of Clinical Trial of Novel Targeted Protein Degrader ICP-490 in China

Retrieved on: 
Thursday, July 7, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, National Medical Products Administration, DLBCL, Patient, CEO, Multiple myeloma, Investigational New Drug, Cancer, Follicular lymphoma, B-cell lymphoma, Degenerative disease, Non-Hodgkin lymphoma, IRF4, Ubiquitin, B cell, Anemia, Lymphatic system, Factor X, Acute kidney injury, NHL, Clinical trial, Hypercalcaemia, IND, NMPA, HKEX, MM, Bone marrow, Pharmaceutical industry

It also has immunomodulatory effects by enhancing the function of effector T cells, resulting from Ikaros and Aiolos degradation and the degradation-mediated releasing of interleukin IL-2.

Key Points: 
  • It also has immunomodulatory effects by enhancing the function of effector T cells, resulting from Ikaros and Aiolos degradation and the degradation-mediated releasing of interleukin IL-2.
  • Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, InnoCare has built a strong pipeline in the field of blood tumor.
  • With the approval of ICP-490 for clinical trials, InnoCare will further strengthen its blood tumor pipeline and aim to provide better treatment options for those patients in China and around the world.
  • We strategically focus on liquid cancer, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide.

Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Coherus and Junshi Biosciences Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, CHRS, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

REDWOOD CITY, Calif., and SHANGHAI, China, July 06, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007

Retrieved on: 
Wednesday, July 6, 2022
Ankylosing spondylitis, OX40L, CDE, AIM, Patient, III, LinkedIn, Atopic dermatitis, Psoriatic arthritis, Adult, OX40, HCM, GLOBE, COVID-19, Population, Cancer, Ligation, U.S. Securities and Exchange Commission, TNFR, Forward-looking statement, National Medical Products Administration, SAN, Therapy, Center, IND, Psoriasis, NMPA, Affibody molecule, HKEX, Silverberg, Sustainable Stock Exchanges Initiative, Private Securities Litigation Reform Act, Safety, Uveitis, Center for Drug Evaluation and Research, Hope, Drug discovery, Protocol, Pharmaceutical industry, Vaccine

Dosing the first participant is an important milestone for the IMG-007 program, said Dr Jonathan Wang, Chairman and Chief Executive Officer of Inmagene.

Key Points: 
  • Dosing the first participant is an important milestone for the IMG-007 program, said Dr Jonathan Wang, Chairman and Chief Executive Officer of Inmagene.
  • We hope the data will help us demonstrate that IMG-007 is one of the strongest OX40 antagonist drug candidates worldwide.
  • It was originally discovered by HUTCHMED, with Inmagene assuming development responsibility at the candidate stage.
  • Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates.

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

Retrieved on: 
Thursday, June 23, 2022
Antibody, Adverse event, National Institute of Virology, Cancer, Fever, Serious adverse event, HCC, Epitope, Death, NMPA, Infection, AST, ILC, Institute, HSA, National Medical Products Administration, Helicobacter pylori, Bloating, CccDNA, Biotechnology, Liver cancer, Bilirubin, Hospital, Engineering, SAE, Peking Union Medical College, Hepatitis B, HBsAg, Disease, TCR, Clinical trial, SCG, Hepatocellular carcinoma, Institute of technology, Neurotoxicity, CRS, AE, Patient, Serum, Diagnosis, Cell, Annual general meeting, HBV, Pharmaceutical industry, Medical device, Vaccine, Virology, MD

SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

Retrieved on: 
Thursday, June 23, 2022
Antibody, Adverse event, National Institute of Virology, Cancer, Fever, Serious adverse event, HCC, Epitope, Death, NMPA, Infection, AST, ILC, Institute, HSA, National Medical Products Administration, Helicobacter pylori, Bloating, CccDNA, Biotechnology, Liver cancer, Bilirubin, Hospital, Engineering, SAE, Peking Union Medical College, Hepatitis B, HBsAg, Disease, TCR, Clinical trial, SCG, Hepatocellular carcinoma, Institute of technology, Neurotoxicity, CRS, AE, Patient, Serum, Diagnosis, Cell, Annual general meeting, HBV, Pharmaceutical industry, Medical device, Vaccine, Virology, MD

SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

EyePoint Pharmaceuticals and OcuMension Therapeutics Announce Approval of New Drug Application by China’s NMPA for YUTIQ® for the Treatment of Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Retrieved on: 
Tuesday, June 21, 2022
ACT, Industry, Eye, FDA, NDA, Therapy, COVID-19, Inflammation, Annual report, NMPA, National Medical Products Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Technology, Motherboard, Compliance, Cataract, Plasma protein binding, Company, CDE, Center for Drug Evaluation and Research, Forward-looking statement, Private Securities Litigation Reform Act, Uveitis, THE, NASDAQ, News, SEC, Stock exchange, Patient, Food, Glaucoma, Visual impairment, Diagnosis, HKSE, GLOBE, Pharmaceutical industry

In April 2021, the CDE accepted OcuMensions new drug application (NDA) for YUTIQ that was filed with the real-world data collected at Boao Lecheng Super Hospital.

Key Points: 
  • In April 2021, the CDE accepted OcuMensions new drug application (NDA) for YUTIQ that was filed with the real-world data collected at Boao Lecheng Super Hospital.
  • We are thrilled to announce the new drug approval for YUTIQ in China.
  • Non-infectious uveitis affecting the posterior segment of the eye is a chronic form of uveitis that may cause a variety of complications, including cataracts and glaucoma.
  • YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA onOctober 12, 2018.