Weekly Roundup of Newly Approved Pharmaceuticals and Recent Biotech IPO Filings

From January 13 to January 18, there was a flurry of good news in the field of drug approvals, bringing new hope to countless patients and injecting strong momentum into the innovative development of the pharmaceuticals industry. Below, let’s focus on the key drugs that were approved for marketing during this period.

On January 13, Pulugliptin Tablets (brand name: Shanzeping), a Class 1 chemical new drug independently developed by CSPC, successfully obtained marketing approval from the National Medical Products Administration.This medication is specifically designed to address blood sugar control issues in adult patients with type 2 diabetes, demonstrating significant efficacy.Results from two pivotal Phase 3 clinical trials show that Pruglitin tablets not only achieve long-acting blood sugar control but also demonstrate excellent safety. It is unlikely to cause hypoglycemia, does not lead to weight gain, has a low incidence of adverse reactions, and poses minimal risk of interactions with other medications. Moreover, dose adjustment is unnecessary even for patients with mild to moderate renal insufficiency. Given that the prevalence of diabetes among adults in China has reached 11.9%, with Type 2 diabetes being the most common, Pruglitin tablets undoubtedly offer a new and high-quality treatment option for a broad patient population.

On the same day, Qilu Pharmaceutical Co., Ltd.'s Edoxaban Tosylate Tablets received approval, drawing significant attention. Edoxaban is a selective inhibitor of factor Xa, and its anticoagulant effect does not require the participation of antithrombin III. It can inhibit free factor Xa and prothrombinase activity, as well as thrombin-induced platelet aggregation. By inhibiting factor Xa, it reduces thrombin generation, thereby preventing thrombosis. This drug is suitable for adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors (such as congestive heart failure, hypertension, age ≥75 years, diabetes, or a history of previous stroke or transient ischemic attack (TIA)), and is used to prevent stroke and systemic embolism. It can also treat adult deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevent the recurrence of adult deep vein thrombosis and pulmonary embolism. As a new option for anticoagulation and cardiovascular and cerebrovascular health protection, it has the advantages of fewer drug interactions, stable dosage, no need for routine monitoring, and no increased risk of gastrointestinal bleeding.

On January 17, Innovent Bio and AOSAIKANG PHARM jointly announced that the new drug application for Oyixin (Liotinib Tablets), a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) targeted drug, has been approved by the National Medical Products Administration.This drug is mainly used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression after previous EGFR-TKI treatment and have been confirmed by testing to have EGFR T790M mutation-positive status.This achievement will further consolidate Innovent Bio's leading position in the field of precision treatment for lung cancer.

In addition, in the drug approval certificate delivery information published on January 13, 2025, multiple drugs were successfully approved. These include Savolitinib tablets from Hutchison MediPharma (Shanghai) Co., Ltd. (for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations), Recacizumab for injection from Guangdong Hengrui Medicine Co., Ltd., and Recombinant Human Tumor Necrosis Factor Receptor Type 2-Antibody Fusion Protein Injection from Hangzhou Bozirui Biopharmaceutical Co., Ltd. These drugs cover various fields such as oncology and immune diseases, providing a wider range of treatment options for patients with different conditions.