Multiple Innovative Drugs from Chinese Pharma Firms Including Simcere and Hansoh Receive FDA Breakthrough Therapy Designation

　　【Pharmaceutical Network Industry Dynamics"Breakthrough Therapy" is another new drug review channel from the U.S. Food and Drug Administration (FDA), following the Fast Track, Accelerated Approval, and Priority Review. Drugs granted "Breakthrough Therapy" designation receive closer guidance from the FDA, ensuring that new treatment options can be provided to patients in a shorter timeframe.
 

According to the review, since August, several innovative drugs have received FDA Breakthrough Therapy Designation, including Simcere, Hansoh Pharma, and other pharmaceutical companies in China.
 

As announced by Simcere on September 2, on August 29, 2024, the sublingual tablet of Xianbi Xin (Edaravone Dexborneol Sublingual Tablet) received FDA Breakthrough Therapy Designation for the treatment of Acute Ischemic Stroke (AIS).
 

Data show that Xianbi Xin sublingual tablets are a brain cell protector composed of two active ingredients, edaravone and dexborneol, which have antioxidant, anti-inflammatory, and synergistic effects, and can significantly reduce brain cell damage caused by AIS. The unique sublingual tablet formulation rapidly disintegrates upon contact with saliva under the tongue, is quickly absorbed into the bloodstream through the sublingual venous plexus to exert its therapeutic effects, and is expected to increase the flexibility of stroke treatment options.
 

On August 20, Hansoh Pharma also announced that its partner, GlaxoSmithKline (GSK), received FDA Breakthrough Therapy Designation for HS-20093 (GSK5764227). This B7-H3 targeted antibody-drug conjugate (ADC) is being evaluated for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed during or after platinum-based chemotherapy (recurrent or refractory).
 

Data show that HS-20093 is a novel B7-H3-targeted antibody-drug conjugate (ADC), composed of a fully humanized B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing multiple Phase I and Phase II clinical trials in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors. On December 20, 2023, Hansoh Pharma entered into an exclusive licensing agreement with GSK, granting GSK a worldwide exclusive license to develop, manufacture, and commercialize HS-20093.
 

In addition, several foreign pharmaceutical companies have also announced the progress of FDA "Breakthrough Therapy" designations. For instance, on August 20, Daiichi Sankyo announced that its重磅 antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), co-developed with AstraZeneca (AZN.US), received Breakthrough Therapy Designation (BTD) from the U.S. FDA. The designation is for the treatment of patients with unresectable or metastatic breast cancer that is hormone receptor (HR)-positive, HER2-low expression (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low expression (defined as IHC 0 with membrane staining). These patients have received two lines of endocrine therapy for their metastatic disease, or experienced disease progression within six months after receiving first-line endocrine therapy combined with a CDK4/6 inhibitor, or within 24 months after receiving adjuvant endocrine therapy.
 

It is reported that Enhertu was first approved by the U.S. FDA in 2019 for the treatment of patients with unresectable or metastatic HER2-positive breast cancer. In April this year, the FDA approved the therapy for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment and lack satisfactory alternative treatment options.
 

In addition, the FDA recently granted Zongertinib, a new drug for the treatment of HER2-positive non-small cell lung cancer (NSCLC), Breakthrough Therapy designation. Specifically, it is used to treat adult patients with advanced, inoperable, or metastatic NSCLC carrying HER2 mutations who have previously received systemic therapy.
 

Data shows that Zongertinib is an oral therapeutic drug developed by the German biopharmaceutical company Boehringer Ingelheim. Data from the Phase 1a/b Beamion LUNG-1 study evaluating the efficacy of Zongertinib will be presented at the World Conference on Lung Cancer (WCLC) on September 9, 2024.
 

Breakthrough Therapy Designation aims to accelerate the development and review of drugs that have the potential to treat serious diseases, with preliminary clinical evidence possibly indicating a substantial improvement over existing therapies. As these innovative drugs receive FDA Breakthrough Therapy Designation, relevant patients can look forward to new treatment options.
 

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