The Breakthrough Therapy Designation in China

Breakthrough Therapy Designation. The Breakthrough Therapy Designation intends to expedite the evaluation of medicines for critical diseases for which there are ...

Cancer Drugs Granted Breakthrough Therapy Designation in China

The findings of this cross-sectional study suggest that BTD has facilitated faster time to market for cancer drugs and improved novelty, but the price of ...

Assessment of the breakthrough-therapy-designated drugs granted ...

The implementation of China's breakthrough therapy designation (BTD) program in 2020 to accelerate drug development for serious or ...

Assessment of the breakthrough-therapy-designated drugs granted ...

The implementation of China's breakthrough therapy designation (BTD) program in 2020 to accelerate drug development for serious or life- ...

Sunvozertinib Receives Breakthrough Therapy Designation for ...

China's CDE has granted breakthrough therapy designation to first-line sunvozertinib for EGFR exon 20 insertion mutation–positive NSCLC.

Bayer receives Breakthrough Therapy designation in China for BAY ...

BAY 2927088 is an oral, small molecule, tyrosine kinase inhibitor under development as a potential new targeted therapy for patients with ...

Blenrep (belantamab mafodotin) in combination receives ... - GSK

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Breakthrough Therapy Designation in China underscores the ...

China's NMPA Grants Breakthrough Therapy Designation ... - OncLive

The Nectin-4–directed antibody-drug conjugate 9MW2821 has received breakthrough therapy designation in China for pretreated, ...

HUTCHMED Receives Breakthrough Therapy Designation in China ...

HUTCHMED (Nasdaq/AIM:HCM;HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and ...

Zai Lab Announces Breakthrough Therapy Designation Granted for ...

“We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China . Today's recognition further supports ...

China's NMPA grants breakthrough therapy status for Innovent's ...

In April 2024, the China NMPA granted priority review for Innovent and Hutchmed's new drug application (NDA) for the combination of sintilimab ...

9MW2821 granted breakthrough therapy designation in China for ...

9MW2821 granted breakthrough therapy designation in China for urothelial carcinoma ... With this designation, the development process for 9MW2821 ...

Breakthrough Designation granted in US and China

SPEVIGO® granted Breakthrough Therapy Designation in the U.S. for the prevention of generalized pustular psoriasis flares.

GSK Blenrep granted Breakthrough Therapy Designation by China's ...

China has granted Breakthrough Therapy Designation (BTD) for Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) for the ...

Akeso's Ivonescimab(PD-1/VEGF BsAbs) Granted Breakthrough ...

Breakthrough Therapy Designation procedure in China is designed to expedite the development and review of innovative drugs with apparent ...

How can you take advantage of China's accelerated regulatory ...

In the first of this series, we will introduce the Breakthrough Therapy Designation (BTD) in China. The BTD program by NMPA is very similar to ...

Jacobio Pharma Announces Breakthrough Therapy Designation ...

Pancreatic cancer is glecirasib's second BTD indication in China. In December 2022, gleciracib was granted BTD for the second line setting and ...

Expedited Programs for Drug Registration in China | ChemLinked

China currently follows four programs for accelerating the review of drug registration applications. 1. Breakthrough therapy designation; 2.

Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Granted ...

The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug ...

China Breakthrough Therapy Designation for Blenrep - Markets data

China Breakthrough Therapy Designation for Blenrep ... Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Breakthrough ...