Roche's Tecentriq Receives FDA Approval for NSCLC Treatment; He Yimin Joins as GI Oncology Head
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Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
【October 17, 2021 / Medical & Pharmaceutical News Digest】Roche's PD-L1 inhibitor receives FDA approval for the treatment of NSCLC; Pfizer's JAK1 inhibitor gains EU CHMP endorsement, poised for approval this year for the treatment of atopic dermatitis; Roche appoints Yimin He as Head of Gastrointestinal Oncology...Daily Latest Pharma & Medical News: Quick Reads to Keep You Informed!
Part 1: Policy Brief
507 non-winning drug specifications were delisted from the procurement platform.
On the 15th, Henan Province issued the "Notice on Publishing the Evaluation Results of Non-Winning Drugs from the Fifth National Centralized Drug Procurement Program," disclosing the evaluated prices for non-winning drug varieties, with 507 drug specifications delisted from the procurement platform. (Henan Public Resources Trading Center)
National Health Commission Issued “Notice on Influenza Prevention and Control Work for the 2021–2022 Season”
Recently, the National Health Commission issued the “Notice on Influenza Prevention and Control for the 2021-2022 Epidemic Season,” clarifying the influenza prevention and control tasks for this year and addressing questions related to influenza vaccines. The document states that health administrative departments across all regions should rationally plan or establish additional influenza vaccination sites, and coordinate the administration of COVID-19 vaccines, influenza vaccines, and other routine vaccines. (National Health Commission)
National Healthcare Security Administration: Studying the Use of Personal Medical Insurance Accounts for Self-Pay Vaccines
On the 15th, the National Healthcare Security Administration, in its response to an NPC deputy's "Proposal on Using Personal Medical Insurance Accounts to Pay for Non-Immunization Program Vaccines," stated that it will study the possibility of including certain non-immunization program vaccines within the payment scope of personal accounts. The Administration will, in accordance with the central government's deployment to deepen the reform of the medical security system, improve the multi-tiered medical security framework comprising basic medical insurance, critical illness insurance, and medical assistance. It will guide local authorities to consolidate medical insurance coverage and benefit levels, optimize the personal accounts for employee medical insurance, and establish and refine an outpatient mutual aid security mechanism. (National Healthcare Security Administration)
National Health Commission: Maternal and Child Health Hospitals to Comprehensively Provide Traditional Chinese Medicine Services
Recently, the National Health Commission issued the "Action Plan for the Improvement of Maternal and Infant Safety (2021–2025)", emphasizing the need to fully leverage the unique role of traditional Chinese medicine (TCM) in preventive healthcare and clinical diagnosis and treatment for women and children, and to establish a collaborative diagnosis and treatment system integrating TCM and Western medicine. According to the plan, by 2022, a TCM service network in the maternal and child health sector will be essentially established, and a series of standardized protocols will be developed and promoted, including TCM diagnosis and treatment guidelines for maternal and child health, as well as TCM preventive intervention programs; by 2025, TCM services will cover the entire life cycle of women and children. (National Health Commission)
Part 2: Industry & Economics Observation
Roche Appoints He Yimin as Head of the Gastrointestinal Cancer Therapeutic Area
It is reported that Roche Pharmaceuticals has announced to its employees that He Yimin will join Roche on October 18 to assume the role of Head of the Gastrointestinal Oncology Therapeutic Area within Roche Pharma China’s Customer Engagement Business Model, reporting to the incoming Head of Oncology. (Medical Representative)
Xunbaihui Bio Completes Series B Financing to Accelerate Drug Pipeline R&D
Recently, Xunbaihui Biotech announced that it has completed a Series B financing round worth tens of millions of US dollars. The proceeds will primarily be used to advance its first fully independently discovered novel-target antibody drug program into clinical development in 2022, while also accelerating the research and development of multiple drug pipelines targeting other cancer immunotherapy targets. (Yiyao Guanlan)
ClearMed Biotechnology Completes 560 Million RMB Series D Financing to Advance Colorectal Cancer Screening Product R&D
On the 15th, ClearMed Biotech officially announced the completion of a Series D financing round totaling RMB 560 million. The proceeds will be primarily allocated to three key areas: first, expanding the product pipeline to further drive the innovation and iteration of its colorectal cancer screening products, alongside the R&D and clinical trials of early screening products for various high-incidence cancers, including lung, bladder, cervical, and liver cancers; second, broadening sales channels, strengthening strategic presence across the healthcare, general wellness, and public health sectors, and expanding into international markets; and third, team building and related initiatives. (VCBeat)
Part 3: Pharmaceutical & Medical News
Treatment Significantly Extends Survival in Liver Cancer Patients: Dual Immunotherapy Combination Achieves Phase 3 Clinical Endpoint
On the 16th, AstraZeneca announced that the combination of its anti-PD-L1 antibody Imfinzi and the investigational anti-CTLA-4 antibody tremelimumab met the primary endpoint of overall survival in a Phase 3 clinical trial for the first-line treatment of patients with unresectable hepatocellular carcinoma. The results demonstrated that, in addition to significantly prolonging patients' overall survival, this innovative dosing regimen also exhibited a favorable safety profile, with the combination of tremelimumab and Imfinzi not increasing severe hepatotoxicity. Imfinzi monotherapy met the non-inferiority criteria compared with the active control arm and demonstrated improved tolerability. (WuXi AppTec)
Roche PD-L1 Inhibitor Approved by FDA for NSCLC Treatment, Reduces Recurrence Risk by 34%
On the 16th, Roche announced that the FDA has approved its PD-L1 inhibitor Tecentriq as adjuvant therapy for patients with stage II–IIIA non-small cell lung cancer (NSCLC) following surgery and platinum-based chemotherapy. This approval is based on the results of an interim analysis of a phase 3 clinical trial. The trial results showed that among patients with stage II–IIIA NSCLC who underwent surgical resection and platinum-based chemotherapy, treatment with Tecentriq reduced the risk of disease recurrence or death by 34%. (WuXi AppTec)
Pfizer's JAK1 Inhibitor Gains EU CHMP Support, Poised for Approval This Year for Atopic Dermatitis
On the 15th, Pfizer announced that the CHMP issued a positive opinion on abrocitinib, recommending its marketing authorization. Abrocitinib is a once-daily oral JAK1 inhibitor indicated for adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Based on the CHMP's opinion, the EU is expected to approve abrocitinib later this year. (WuXi AppTec)
EU CHMP Backs AbbVie’s IL-23 Inhibitor, Poised to Secure New Indication
On the 15th, AbbVie announced that the CHMP recommended approval of risankizumab as monotherapy or in combination with methotrexate for the treatment of active psoriatic arthritis in adults who have had an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). (WuXi AppTec)
Chinese-Made Bivalent HPV Vaccine Obtains WHO PQ Certification
On the 16th, Wantai Bio released the "Announcement on the Bivalent HPV Vaccine Passing WHO PQ Certification." The announcement stated that its wholly-owned subsidiary, Xiamen Wantai Canghai Biotechnology Co., Ltd., received an official letter from the World Health Organization confirming that its developed "Bivalent Human Papillomavirus Vaccine" has passed the WHO Prequalification (PQ) certification. (Corporate Announcement)
Bristol Myers Squibb’s Class 1 Innovative Drug Approved for Clinical Trials in China
According to the latest public notice on the official website of the CDE, the Class 1 innovative drug BMS-986278-01 tablets, submitted by Bristol-Myers Squibb, has been approved for two clinical trials in China for the indication of idiopathic pulmonary fibrosis. (WuXi AppTec)
Jacobio Pharmaceuticals' CD73 Monoclonal Antibody JAB-BX102 Enters Clinical Stage
On the 15th, Jacobio Pharmaceuticals announced that its clinical trial application for the CD73 monoclonal antibody JAB-BX102 has been approved by the U.S. FDA, and a Phase 1/2a clinical trial will be conducted in the United States. (WuXi AppTec)
AstraZeneca's Oral Estrogen Receptor Degrader AZD9833 Initiates Clinical Trials
On the 15th, the CDE Clinical Trial Registration Platform indicated that AstraZeneca's oral estrogen receptor degrader AZD9833 has initiated a Phase III clinical trial in China. Currently, eight clinical trials for AZD9833 are ongoing globally, including two Phase III trials, SERENA-4 and SERENA-6. (CDE)
*Disclaimer: This article was written by a contributing author to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.