Four Innovative Drugs from Shengdi Pharma, Takeda and Others Granted Breakthrough Therapy Designation in China

　　【Pharmaceutical Network Industry DynamicsAccording to the news released on September 14 by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, multiple innovative drugs have been included in the Breakthrough Therapy Drug Program. These drugs involve several pharmaceutical companies such as SUNCADIA, Wuxi Zhikang Hongyi Biotechnology Co., Ltd., Suzhou Zanrong Pharmaceutical Co., Ltd., and Takeda (China).
 

According to the September 14 announcement on the CDE website, the drug "SHR-1918 Injection," jointly applied for by Beijing SUNCADIA Pharmaceutical Co., Ltd. and Suzhou Shengdiya Biopharmaceutical Co., Ltd., has been approved for inclusion in the breakthrough therapy drug program after review. The public comment period ends on September 14, 2024.
 

Data show that SHR-1918 injection is a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), which reduces the levels of triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) in serum by inhibiting the activity of ANGPTL3. LDL-C and TG are significant risk factors for the occurrence and progression of atherosclerotic cardiovascular diseases. ANGPTL3 plays an important role in regulating lipid metabolism, as it can reduce the clearance of TG and LDL-C by inhibiting lipoprotein lipase and endothelial lipase.
 

According to CDE news on September 14, the drug "SC0062 capsule" jointly applied for by Wuxi Zhikang Hongyi Biotechnology Co., Ltd. has been approved for inclusion in the breakthrough therapy drug program after review. The public announcement will end on September 14, 2024.
 

Data show that SC0062 is a novel molecular design targeting chronic kidney disease, and a highly selective endothelin receptor A (ETA) antagonist. It can improve renal blood flow, reduce proteinuria, and mitigate inflammation and the fibrosis process. The design and development goal of this investigational product is to further enhance drug safety while ensuring efficacy, such as alleviating fluid retention—an adverse event associated with non-selective or low-selective ET antagonists.
 

SC0062 demonstrated good safety, tolerability, and predictable pharmacokinetic characteristics in the completed Phase 1 study. No fluid retention adverse events were observed in either the Phase 1 trial with healthy volunteers or the IgA nephropathy patient cohort in the Phase 2 study. Additionally, SC0062 showed clinically meaningful and statistically significant improvement in reducing proteinuria, with clear dose-dependency and good safety.
 

According to the CDE news on September 14, the drug "ZN-A-1041 Enteric Capsules" jointly applied for by Suzhou Zanrong Pharmaceutical Technology Co., Ltd. has been reviewed and approved for inclusion in the Breakthrough Therapy Drug Program. The public announcement will end on September 14, 2024.
 

Data show that ZN-A-1041 enteric-coated capsules are an orally administered selective tyrosine kinase inhibitor targeting human epidermal growth factor receptor 2 (HER2), with high blood-brain barrier permeability. Therefore, it has the potential to treat patients with HER2-positive breast cancer brain metastases and prevent the occurrence of brain metastases. Notably, in May 2023, Zanrong Pharmaceutical Technology Co., Ltd. announced an agreement with Roche to acquire the global rights to the oral small molecule HER2 inhibitor ZN-A-1041.
 

According to a CDE announcement on September 14, the drug "TAK-861 Tablets" jointly submitted by Takeda (China) International Trading Co., Ltd. has been approved for inclusion in the breakthrough therapy drug program after review. The public announcement will end on September 14, 2024.
 

Data show that TAK-861 is an oral orexin receptor 2 (OX2R) agonist. It aims to address the orexin deficiency in NT1 by selectively stimulating orexin receptors. Agonists that activate orexin receptor 2 may replace endogenous orexins and activate signaling pathways that promote wakefulness.
 

It was reported that in June this year, Takeda announced positive results from the Phase 2b clinical trial of TAK-861 in treating type 1 narcolepsy. The primary endpoint of the Phase 2b trial showed that all dose groups demonstrated statistically significant and clinically meaningful improvements compared to the placebo group in the Maintenance of Wakefulness Test (MWT) for delaying sleep onset (p≤0.001). The improvements were sustained over 8 weeks. Additionally, the Phase 2b data also supported the U.S. Food and Drug Administration (FDA) granting TAK-861 Breakthrough Therapy Designation for the treatment of excessive daytime sleepiness in NT1.
 

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