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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China Waives Import Tariffs for Active Ingredients of Anti-cancer and Rare Disease Drugs in 2024
China will waive import tariffs for 62 active pharmaceutical ingredients (API) of anti-cancer drugs and 5 APIs of rare disease drugs, starting from Jan 1, 2024. Medical products such as nirmatrelvir for COVID-19, insulins for diabetes, vaccines, gene therapies, and more will also enjoy interim zero tariffs.
Jan 01, 2024
PIPELINE
Chinese Antibody-drug Conjugates (ADCs) Licensed Overseas Exceeds $23 Billion This Year
On Dec 20, 2023, Hansoh Pharma, a Chinese biopharma company, announced that it had reached an exclusive deal with GSK for HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3. This deal is one of 15 cross-border licensing deals inked this year between Chinese ADC-focused companies and multinational corporations this year.
Dec 21, 2023
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Rare Disease
Drug Registration
New Drug
Respiratory Disease
Monthly Report: New Drug Approvals in China | October 2023
In Oct 2023, China NMPA approved 15 new drugs, among which 12 are chemical drugs and 3 are biological products: 1. BMS’ Deucravacitinib Tablets (SOTYKTU); 2. Pfizer’s Ritlecitinib Tosylate Capsules (LITFULO); 3. Janssen-Cilag International’s Rilpivirine Injection; 4. Luye Pharma’s Rivastigmine Twice Weekly Transdermal Patch; 5. Abbvie’s Upadacitinib Sustained-release Tablets (RINVOQ)...
Nov 06, 2023
INDUSTRY
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Rare Disease
Drug Registration
Monthly Report: New Drug Approvals in China | September 2023
In Sept. 2023, China NMPA approved 19 new drugs, among which 12 are chemical drugs and 7 are biological products:
1. Luye Life Sciences’ Goserelin Microspheres for Injection
2. HRA Pharma Rare Diseases’ Mitotane Tablets
3. N.V. Organon’s Ezetimibe and Atorvastatin Calcium Tablets
4. Napp Pharmaceuticals’ Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation
5. Sinotau Pharmaceuticals’ Florbetaben [¹⁸F] Injection (Ouweining)
6. Grand Pharma’s Carglumic Acid Dispersible Tablets (Anweide)
7. CSPC Ouyi Pharmaceutical’s Irinotecan Hydrochloride Liposome Injection
8. Qilu Pharmaceutical’s Dolutegravir Sodium Tablets
9. Gowell Pharma’s ω-3 Fish Oil Fat Emulsion Injection
10. Acebright Pharma’s Neratinib Maleate Tablets
11. Brilliant Pharmaceuticals’ Dacomitinib Tablets
12. Grand Life Sciences’ Etomidate Injectable Emulsion
13. Shanghai JMT-Bio Technology’s Narlumosbart Injection
14. Henlius’ Serplulimab Injection (Hansizhuang)
15. Eli Lilly’s Insulin Lispro Injection (Youmile)
16. Sanofi’s Dupilumab Injection (Dupixent)
17. Eli Lilly’s Dulaglutide Injection (TRULICITY)
18. MSD’s Pembrolizumab Injection (Keytruda)
19. Novartis’ Erenumab Injection (Aimovig)
Oct 09, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | June 2023
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
Jul 07, 2023
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Vaccine
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | May 2023
In May 2023, China NMPA approved 27 new drugs, among which 16 are chemicals and 11 are biologics: 1. Betta Pharma’ Befotertinib Mesylate Capsules; 2. Sanhome Pharma’s Alfosbuvir Tablets; 3. Novartis’ Ribociclib Succinate Tablets...
Jun 12, 2023
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
CMC
Clinical Trial
Volume-based Procurement
Cancer
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2023
Regulatory updates in Apr. 2023: 1. China Grants Four Rx-to-OTC Switches; China Adjusts Catalogs of Anesthetics and Psychoactive Drugs; China Reveals the 8th Medical VBP’s Bidding Result...
May 15, 2023
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