NMPA

CANbridge Announces Full Enrollment Reached in China Region of the Global LIVMARLI® (CAN108) EMBARK Phase 2 Study in Biliary Atresia

Retrieved on: 
Tuesday, May 30, 2023

This global, multi-center, randomized controlled Phase 2 study, evaluating the efficacy and safety of LIVMARLI in patients with BA after Kasai surgery, is sponsored by Mirum Pharmaceuticals, Inc. and has also completed enrollment across the other global locations where the trial is open.

Key Points: 
  • This global, multi-center, randomized controlled Phase 2 study, evaluating the efficacy and safety of LIVMARLI in patients with BA after Kasai surgery, is sponsored by Mirum Pharmaceuticals, Inc. and has also completed enrollment across the other global locations where the trial is open.
  • CANbridge has an exclusive license agreement for the development, commercialization and manufacturing, under certain conditions, of LIVMARLI in Greater China.
  • In this region, CANbridge has the right to develop and commercialize LIVMARLI for three indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA).
  • CANbridge also expects to file an NDA for LIVMARLI for the treatment of PFIC with the NMPA soon.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

Retrieved on: 
Wednesday, May 31, 2023

To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Galvanize Announces License Agreement and Partnership with Energenx Medical for its Technologies in China

Retrieved on: 
Tuesday, May 30, 2023

Recognizing the potential for its technologies in China, Galvanize worked with its founding investor Apple Tree Partners (ATP) to form Energenx in 2021.

Key Points: 
  • Recognizing the potential for its technologies in China, Galvanize worked with its founding investor Apple Tree Partners (ATP) to form Energenx in 2021.
  • We are also excited to advance our Aliya soft tissue ablation system in China through our relationship with Energenx."
  • Using RheOx as the first collaboration opportunity, together, we are establishing leadership in interventional pulmonology with continued pipelines in China and globally.
  • The procedure was performed using a minimally-invasive approach through a bronchoscope and the patient was discharged soon after without complications.

Inventiva announces that its partner Sino Biopharm received IND approval from the NMPA to initiate clinical trial with lanifibranor in China

Retrieved on: 
Thursday, May 25, 2023

Frederic Cren, CEO and cofounder of Inventiva, stated: “We are extremely pleased by this positive feedback from the NMPA, which allows our lead compound to advance into a Phase III clinical trial in NASH in mainland China.

Key Points: 
  • Frederic Cren, CEO and cofounder of Inventiva, stated: “We are extremely pleased by this positive feedback from the NMPA, which allows our lead compound to advance into a Phase III clinical trial in NASH in mainland China.
  • This is an important milestone for us and our partner Sino Biopharm, and brings new opportunities for patients affected by NASH in China to participate in the global NATiV3 Phase III clinical trial.
  • We are looking to successfully develop lanifibranor with Sino Biopharm and potentially commercialize in China the first oral treatment for patients with NASH.”
    Philip Duong, Head of Overseas BD & Alliance, Sino Biopharm: “We are delighted to have received the IND approval from the Chinese NMPA.
  • CTTQ will be responsible for all costs linked to lanifibranor development in China.

BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1

Retrieved on: 
Wednesday, May 24, 2023

LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.

Key Points: 
  • LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.
  • BRY812 is a LIV-1 targeting ADC developed on BioRay's CysLink™ technology platform where highly stable conjugation is created through irreversible chemistry.
  • Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.
  • Dr. Haibin Wang, CEO of BioRay, stated, "Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805.

BioRay Filed IND Application for BRY812, a Novel Antibody Drug Conjugate Targeting LIV-1

Retrieved on: 
Wednesday, May 24, 2023

LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.

Key Points: 
  • LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity.
  • BRY812 is a LIV-1 targeting ADC developed on BioRay's CysLink™ technology platform where highly stable conjugation is created through irreversible chemistry.
  • Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.
  • Dr. Haibin Wang, CEO of BioRay, stated, "Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805.

Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers

Retrieved on: 
Tuesday, May 23, 2023

To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.

Key Points: 
  • To date, Antengene has received 3 ODDs from the FDA for two of its in-house products.
  • Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions.
  • The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.
  • Moving forward, Antengene will work closely with regulators and clinical investigators to advance the CLINCH trial and fully assess ATG-022's therapeutic potential for solid tumors."

IceCure Medical Reports First Quarter 2023 Financial & Operational Results

Retrieved on: 
Monday, May 22, 2023

Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses

Key Points: 
  • Builds Momentum as ProSense is Featured at Medical Conferences and Educational Courses
    CAESAREA, Israel, May 22, 2023 /PRNewswire/-- IceCure Medical Ltd. (the "Company" or "IceCure") (Nasdaq: ICCM) (TASE: ICCM) developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the three months ended March 31, 2023 as well as operational and recent corporate developments.
  • We believe this momentum in the market is bolstered by a broader trend toward minimally invasive procedures," stated IceCure CEO Eyal Shamir.
  • Company's Ordinary Shares to Trade Exclusively on Nasdaq: IceCure announced its voluntary delisting from the Tel Aviv Stock Exchange ("TASE").
  • In the first quarter of 2023, sales increased in the U.S. and Europe relative to the same quarter last year.

Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA

Retrieved on: 
Thursday, May 18, 2023

SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
  • “The CDE’s decision to grant priority review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • It is implemented under the Drug Registration Regulation (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Interim, NMPA 2020 No.
  • According to the regulation and guidance, the regulatory authority will prioritize the evaluation resources for applications under priority review to expedite the review and approval timelines.

HiST Pharma Announces U.S. FDA Approval to Initiate Phase III Clinical Study With TC Cream – World’s First Botanical Small-Molecule Drug That Treats Psoriasis Vulgaris

Retrieved on: 
Wednesday, May 17, 2023

HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).

Key Points: 
  • HiST Pharma through its wholly-owned Psoriasis Research Institute of Guangzhou (PRIG) announces today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) TC Cream to launch a U.S.-based multicenter Phase III clinical study to treat patients with psoriasis vulgaris, following a previously completed Phase IIb trial (NCT03372811).
  • “The initiation of a Phase III clinical trial for our IND, approved by the FDA, is another key milestone for the company in the final stage of our world’s first botanical new drug development following a successful Phase IIb trial for the treatment of psoriasis."
  • “The initiation of a Phase III clinical trial of our IND in the U.S. is another key milestone for the company in the final stage of our world’s first botanical new drug development.
  • With the clinical clearance from the FDA, we are one step closer to bringing TC to benefit millions of patients affected by this debilitating disease.