327 Drug Products to Enter China\’s 7th Round of Volume-based Procurement (VBP)

On July 13, the National Joint Drug Procurement Office announced the preliminary result for the bid of the 7th round of volume-based procurement (VBP). 327 products (61 drugs if differentiated by active ingredients) owned by 217 companies won the bid in the preliminary stage. The bid-winning products cover 31 disease categories, including common and/or chronic diseases such as hypertension, diabetes, gastrointestinal disorders and severe diseases of lung/liver/kidney/colon cancer. The bid-winning products\’ prices were reduced by 48% on average. In terms of kidney cancer drugs, the average price of Lenvatinib Mesilate Capsules was cut by 83.33% from 108 yuan/capsule to 18 yuan/capsule. Among drugs for treating high blood pressure, Nifexdipine Controlled-release Tablets\’ average price dropped by 58% and Metoprolol Succinate Sustained-Release Tablets\’ by 53%. Of the 327 products, six are from international pharma companies and their VBP prices are listed below. Drug Product Specification Company VBP Price Oseltamivir Phosphate Capsules 75mg*10 capsules per…

Jul. 15th, 2022

327 Drug Products to Enter China\’s 7th Round of Volume-based Procurement (VBP)

On July 13, the National Joint Drug Procurement Office announced the preliminary result for the bid of the 7th round of volume-based procurement (VBP). 327 products (61 drugs if differentiated by active ingredients) owned by 217 companies won the bid in the preliminary stage. The bid-winning products cover 31 disease categories, including common and/or chronic diseases such as hypertension, diabetes, gastrointestinal disorders and severe diseases of lung/liver/kidney/colon cancer. The bid-winning products\’ prices were reduced by 48% on average. In terms of kidney cancer drugs, the average price of Lenvatinib Mesilate Capsules was cut by 83.33% from 108 yuan/capsule to 18 yuan/capsule. Among drugs for treating high blood pressure, Nifexdipine Controlled-release Tablets\’ average price dropped by 58% and Metoprolol Succinate Sustained-Release Tablets\’ by 53%. Of the 327 products, six are from international pharma companies and their VBP prices are listed below. Drug Product Specification Company VBP Price Oseltamivir Phosphate Capsules 75mg*10 capsules per…

Jul. 15th, 2022

H1 2022: Top 12 China Generic Drug Approval Winners

In the first half of 2022, China National Medical Products Administration (NMPA) approved 210 domestically-manufactured generic drugs for marketing authorization. Overview of the Top 12 Companies Yangtze River Pharmaceutical is the biggest winner, owning 14 approved generic drugs, followed by Sichuan Kelun Pharmaceutical and Beite Pharmaceutical with 11 approved generics respectively. Jiangsu Hengrui Pharmaceutical takes the fourth and fifth places with 9 generic products and CSPC Pharmaceutical with 8 generics. Ranking Company Approved Generic Drugs Approved Generic Drug Applications 1 Yangtze River Pharmaceutical 14 18 2 Sichuan Kelun Pharmaceutical 11 18 2 Beite Pharmaceutical 11 15 4 Jiangsu Hengrui Pharmaceuticals 9 12 5 CSPC Pharmaceutical 8 12 6 CR Pharmaceutical 7 7 6 SSY Group 7 7 8 Reyoung Pharmaceutical 6 8 9 Qilu Pharmaceutical 5 7 9 Easton Biopharmaceuticals 5 6 9 Sino Biopharmaceutical 5 5 9 Tianyu Pharm 5 5   Data source: Menet.com.cn * Notes: The approved generic…

Jul. 14th, 2022

New Drug Approvals in China | June 2022

Editor\’s Notes: New drugs in this article refer to Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China; Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China; First generic drugs in China. *\”First generic drug in China\” refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market. In June 2022, China NMPA approved 25 new drugs, including 17 chemical drugs and 8 biological products. 1. Jiangsu Hengrui Pharmaceuticals\’ SHR3680 Tablets; 2. Bayer\’s Finerenone Film-coated Tablets (Kerendia); 3. Qilu Pharmaceutical\’s Aripiprazole Oral Soluble Film; 4. Qilu Pharmaceutical\’s Memantine Hydrochloride Oral Soluble Film; 5. Boehringer Ingelheim\’s Empagliflozin Tablets; 6. Jiangsu Hengrui Pharmaceuticals\’ Pyrotinib Maleate Tablets; 7. Shenzhen China Resources…

Jul. 12th, 2022

Updates on Pharmaceutical Regulations in China | June 2022

This is a collection of China\’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities: National Medical Products Administration (NMPA); NMPA\’s Center for Drug Evaluation (CDE); National Health Commission (NHC); National Healthcare Security Administration (NHSA); National Joint Drug Procurement Office; Chinese Pharmacopoeia (ChP) Commission. For more details about the summarized contents below, please send an enquiry to contact@chemlinked.com. 1. CDE Issues the 2021 China Drug Evaluation Report On June 1, CDE issued the 2021 China CDE Drug Evaluation Report, revealing that 47 innovator drugs were approved in 2021. BaiPharm has selected critical information and compiled it into a report, which covers the following information: The accepted, reviewed, and approved drug applications; The expedited approvals; Onsite inspections; Approved medical products in significant therapeutic areas; Disapproval reasons; Reforms of the drug review & approval system. ChemLinked BaiPharm members can download the report for free at BaiPharm Insight. (Read More) 2. CDE Publishes…

Jul. 08th, 2022

2021 China CDE Drug Evaluation Report is Out!

On June 1, China Center for Drug Evaluation (CDE) released the 2021 China Drug Evaluation Report. ChemLinked BaiPharm Team selected excerpts from the report to help pharmaceutical companies understand the data and reform trends of China\’s drug review and approval. ChemLinked BaiPharm Report contains the significant data of drug evaluation. The report can be downloaded for free at the bottom of this page. Contents 1. Acceptance of Applications 1.1 Overview of Applications 1.2 Acceptance of Innovator Drug Applications 1.3 Accepted TCM Applications Requiring Technical Review 1.4 Accepted Chemical Drug Applications Requiring Technical Review 1.5 Accepted Biological Product Applications Requiring Technical Review 2. Review of Applications 3. Approval of Applications 3.1 Overview of Approval/Recommended Approval 3.2 Approval of Innovator Drug Applications 3.3 Approval/Recommended Approval of TCM Applications 3.4 Approval/Recommended Approval of Chemical Drug Applications 3.5 Approval/Recommended Approval of Biological Product Applications 4. Expedited Approval 4.1 Breakthrough Therapy Designation (BTD) 4.2 Conditional Approval (CA)…

Jul. 05th, 2022

China Stresses Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List

On June 29, 2022, China National Healthcare Security Administration (NHSA) issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL) (hereafter referred to as NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity. 1. Which Drugs Can Apply for Entering NRDL The Work Plan specifies the six conditions1 that drugs can apply for entering NRDL: Drugs approved by National Medical Products Administration (NMPA) with new generic names between January 1, 2017, to June 30, 2022. Drugs with major indication changes approved by NMPA between January 1, 2017, to June 30, 2022. Drugs in the latest version of COVID-19 Pneumonia Diagnosis and Treatment Plan. Drugs in the 2018 National Essential Drug List. Drugs in the Encouraged Generic Drug List / List of Pediatric Drugs Encouraged for R&D and Application and approved by NMPA before June 30, 2022. Rare disease drugs (orphan drugs) approved by NMPA before June 30, 2022….

Jul. 04th, 2022

Understanding the Requirements of New Food Ingredients/Additives Registration in Thailand

The use of ingredients and food additives in Food is ruled by FDA notifications (one of the mains is Notification No. 418 issued in 2020 and subsequent modifications). During assessment or application for a food or dietary supplement product, it may happen that the system can’t find one of your ingredients or the same may not be allowed for your declared use. In such case, we have two solutions: a) modify/change the ingredient/additive or b) register the ingredient/additive in the system. Depending on whether the product is a plant, an excipient, an additive, we have several different ways to do it. In this webinar, we’ll explain to you all, from the easier to the more complex. Contents Part 1 Regulatory background – laws and notifications 1.1 General overview 1.2 Laws and notifications Part 2 How ingredients are classified 2.1 The theory: Lists in notification 2.2 The practice: ingredients in FDA…

Jul. 01st, 2022

China CFDI 2021 Drug Inspection Overview

On June 26, 2022, China Center for Food and Drug Inspections (CFDI), a public institution under National Medical Products Administration (NMPA), issued the 2021 Work Report on Drug Inspections. The Report says that in 2021, CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections. Contents 1. Drug Registration Inspections 2. Drug Supervision Inspections 3. Overseas Inspections 4. License Inspections   1. Drug Registration Inspections 1.1 Definition Drug registration inspections verify the authenticity and consistency of the application materials, the commercial production condition, the compliance of R&D and manufacturing processes, and data integrity, etc. 1.2 Data In 2021, CFDI completed 1,214 drug registration inspections, including 1,066 inspections for clinical trial applications and marketing authorization applications; 148 inspections for the generic drugs\’ quality and therapeutic equivalence evaluations. 10 inspections reported failure results. 1.3 Problems Problems found in pharmacology and toxicology study inspections mainly include…

Jun. 30th, 2022

China Kicks off the 7th Round of Volume-based Procurement (VBP) of Drugs

On June 20, China National Joint Drug Procurement Office announced the start of the 7th round of volume-based procurement (VBP), covering 59 drugs with different active pharmaceutical ingredients. Companies qualified to supply the drugs are required to submit tenders on July 12. Procurement Volume, Term, and Price Limit The office also released each drug\’s total procurement volume, the percentage of procurement volume, and the price limit. For most chemical drugs, the procurement rules are as follows: Number of bid winners Procurement Volume of the 1st Year / the Total Agreed Procurement Volume * 100% Procurement Term 1 50% 1 year 2 60% 1 year 3 70% 2 years ≥ 4 80% 3 years For example, Afatinib Tablets (30mg)\’s tender price limit is required to be no higher than 112.3267 yuan. The drug\’s total procurement volume of the first year in the procurement term is 596,327 tablets. If there is only one…

Jun. 27th, 2022
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