Multiple Drugs from Hengrui, AbbVie and Others Granted Breakthrough Therapy Designation in China

　　【Pharmaceutical Network Industry DynamicsBreakthrough therapy drugs refer to medications used for the prevention or treatment of diseases that severely impact quality of life or are life-threatening, and for which there are currently no effective means of prevention or treatment, or where there is sufficient evidence indicating a significant clinical advantage over existing treatments. According to relevant regulations, drugs classified under breakthrough therapy may have an expedited approval process. Based on announcements from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA), since May 2024, numerous drugs have been designated as breakthrough therapies, a development worth noting.
 

On May 23, according to the CDE website, the drug "Targeted CD19 Genetically Engineered Autologous T-cell Injection with Silencing Interleukin-6 Expression Function" jointly applied for by SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD has been approved for inclusion in the breakthrough therapy drug program after review. The public announcement deadline is May 23, 2024. The public announcement information shows that the drug type of "BDB-001 Injection" is therapeutic biological product, and the proposed indication (or function) is: refractory/relapsed acute lymphoblastic leukemia.
 

On May 21, the CDE website announced that Hengrui Pharma's SHR-A1921 for injection is proposed to be included in the breakthrough therapy designation. The indication is for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. According to publicly available information from Hengrui Pharma, this is a self-developed TROP-2-targeted antibody-drug conjugate (ADC). Previously, the drug’s treatment of platinum-resistant recurrent epithelial ovarian cancer was granted Fast Track designation by the U.S. FDA. Notably,
 

On May 17, the CDE website announced that GENRIX BIO's Class 1 new drug GR2001 Injection is proposed to be included in the breakthrough therapy designation for the prevention of tetanus. According to public data, GR2001 is a recombinant humanized monoclonal antibody against tetanus toxin (tetanus toxin, TeNT) independently developed by GENRIX BIO. It is registered as a therapeutic biological product Class 1, and its target is the C-terminal of the TeNT heavy chain.
 

On May 16, the CDE website announced that the upadacitinib tablets submitted by AbbVie are proposed to be included in the breakthrough therapy category for the treatment of adolescent and adult patients aged 12 years and above with non-segmental vitiligo. Public information shows that the Chinese generic name for upadacitinib is Upadacitinib Extended-Release Tablets, a JAK inhibitor that has previously been approved in China for treating various other indications. In addition, according to AbbVie's website, the indication for Upadacitinib Extended-Release Tablets in treating vitiligo is currently in Phase 3 clinical research.
 

On May 14, Brii Biosciences announced that two of its investigational drugs, the hepatitis B virus (HBV)-specific broad-spectrum neutralizing monoclonal antibody BRII-877 (tobevibart) and the HBV-targeted small interfering RNA (siRNA) BRII-835 (elebsiran), were designated as breakthrough therapies by the CDE. BRII-877 (tobevibart) is a subcutaneously administered investigational neutralizing monoclonal antibody designed to block the entry of hepatitis B virus (HBV) and hepatitis D virus (HDV) into liver cells and reduce the levels of viral particles and subviral particles in the blood. BRII-835 (elebsiran) is a subcutaneously administered investigational siRNA drug targeting HBV, with the potential for direct antiviral activity against HBV and HDV and the induction of an effective immune response.
 

On May 5, earlier this year, Innovent Bio announced that the company's Claudin18.2 (CLDN18.2) antibody-exatecan conjugate (ADC) IBI343 had been included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The proposed indication is for patients with CLDN18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma who have received at least two prior systemic therapies.
 

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