On March 12, 2026, Eli Lilly and Company issued an open letter to the public, warning of potential safety risks associated with compounded medications that mix tirzepatide with vitamin B12. Lilly stated that its testing revealed a chemical reaction between tirzepatide and B12 in compounded formulations, producing significant levels of unknown impurities. The short term and long term effects of these impurities on the human body remain completely unknown. This warning has once again drawn public attention to the gray area of compounded drug formulations. Unknown Impurities Detected Safety Profile Completely Unknown In its open letter, Eli Lilly disclosed that it had tested commercially available compounded products combining tirzepatide with B12 (including methylcobalamin, hydroxocobalamin, or cyanocobalamin) and found them to contain substantial levels of unknown impurities. These impurities are products of a chemical reaction between tirzepatide and B12. Lilly emphasized that no research data exist regarding the pharmacological properties ...
Anticoagulants occupy a unique niche on the global bestselling drugs ranking. Unaffected by sudden pandemics or short-lived market trends, they have long secured a core position in the global pharmaceutical market driven by rigid clinical demand. In 2025, apixaban ranked sixth globally with $14.4 billion in worldwide sales, earning its title as the undisputed “King of Anticoagulants”. This sales figure not only surpassed blockbuster oncology drugs such as Opdivo and daratumumab, but also exceeded popular chronic disease medications like dapagliflozin. Beneath this prosperity, however, patents are expiring, and the billion-dollar era of the “xaban” class is drawing to a close. Yet the anticoagulant sector will not halt its progress: a new generation of blockbuster drugs is on the horizon. / 01 / An Unmatched Commercial Logic The enormous size of the anticoagulant market is hardly surprising. As the name suggests, antithrombotic drugs inhibit thrombus formation, promote thrombolysis, or prevent ...
Recently, Dorzagliatin, an innovative type 2 diabetes drug developed by Hua Medicine, has been approved for marketing by the Office of Pharmaceutical Products, Department of Health, Hong Kong Special Administrative Region. It has become the first general drug (a widely used medicine for common diseases) approved under Hong Kong’s “1+” Fast Track Approval Mechanism for new drugs. In 2023, the Shanghai-based enterprise highlighted through this newspaper the difficulties faced by domestic innovative drugs in seeking market approval in Hong Kong. Today, its wish has been fulfilled, as the innovative drug has been approved via the “direct access” route in Hong Kong. Holding both mainland and Hong Kong drug registration certificates, the company plans to expand to Southeast Asia, opening up broad overseas markets for domestic innovative drugs. For a long time, Hong Kong implemented the “2+” Approval Mechanism, which required new drugs to be first launched in two “listed countries” ...
Recently, Shenzhen Baitewei Medical Technology Co., Ltd. (“Baitewei Medical”) announced the completion of a nearly 100 million yuan Series B financing round. The round was led by Tasly Capital, with Qinzhi Capital as a co-investor, and Vision Capital acted as the exclusive financial advisor. The proceeds will mainly be used for new product R&D, production base construction and market expansion, accelerating the company’s layout of innovative products in peripheral vascular intervention and heart failure. Building a peripheral intervention product matrix, achieving domestic breakthroughs in multiple devices In the field of peripheral vascular intervention, Baitewei has established a full product matrix covering “thromboreduction + thrombectomy + access”, with multiple technologies at a leading domestic level. Several devices have achieved domestic breakthroughs and successfully obtained market approval. Meanwhile, a number of additional innovative products are in the clinical application and registration stage, forming a full-cycle and sustainable product R&D and commercialization ...
Drugdu.com expert’s response: Differences in Registration Application Requirements for In Vitro Diagnostic (IVD) Medical Devices between China and the European Union The differences in registration application requirements for IVD medical devices between China and the European Union are mainly reflected in classification rules, conformity assessment paths, technical documentation requirements, quality management systems, clinical evaluations, and post-market surveillance and traceability. Here is a detailed introduction: I. Classification Rules China: Based on risk, IVD products are classified into Class I, II, and III. The classification rules are relatively clear, with reference to the detailed “Classification Catalog of In Vitro Diagnostic Reagents.” European Union (IVDR): Based on risk, IVD products are classified into Class A, B, C, and D (with risk increasing from low to high). The classification rules are more refined and stricter, following the rules in Annex VIII. A key change under the IVDR is that a large number of products ...
Recently, Jilemei® (soximerexyl sulfate tablets), a Class 1 innovative drug supported by Fangda Pharmaceutical (Suzhou) Co., Ltd. in the clinical stage, has been granted priority review and approval by the National Medical Products Administration and conditionally approved for marketing . Developed by Zhejiang Hangyu Pharmaceutical, a subsidiary of Jiming Kexin , this drug is intended to treat adult patients with advanced non-small cell lung cancer ( NSCLC ) with murine sarcoma virus oncogene ( KRAS ) G12C mutation who have received at least one systemic therapy , providing a new treatment option for this lung cancer subtype with a well-defined molecular target. As a partner, Fangda’s team completed the production , quality release, and stability studies of Phase I and Phase II clinical samples , and provided integrated services such as clinical double-blind labeling , sample storage management , clinical drug delivery, and international transportation . With its efficient, professional, ...
March 13th – Cyto BiotechThe announcement stated that the company’s controlling subsidiary, Shandong Srui Pharmaceutical Co., Ltd., received a certificate from the National Medical Products Administration for dexamethasone, a chemical raw material.”Notification of Approval for Drug Marketing Application”. Dexamethasone is a long-acting glucocorticoid with anti-inflammatory, anti-allergic, and immunosuppressive effects. It is mainly used for allergic and autoimmune inflammatory diseases, such as connective tissue diseases, severe bronchial asthma, dermatitis, ulcerative colitis, acute leukemia, and malignant lymphoma. https://finance.eastmoney.com/a/202603133671477849.html
On March 11, China’s first innovative drug for precise postoperative assessment of differentiated thyroid cancer was launched.Human thyroid-stimulating hormone beta (Zesuning) for injection at the First Affiliated Hospital of Zhejiang University School of MedicineThe first prescription was issued by Jiangsu Provincial People’s Hospital . Thyroid cancer is one of the fastest-growing solid tumors in recent years. Differentiated thyroid cancers, such as papillary carcinoma and follicular carcinoma, account for over 90% of cases. These tumors generally have a good prognosis, with a 10-year survival rate exceeding 90%. However, a high survival rate does not mean “no management is needed.” Studies show that approximately 10%-30% of patients still face the risk of recurrence or metastasis during postoperative follow-up. Therefore, regular and standardized postoperative follow-up to monitor for residual lesions or signs of recurrence is crucial for improving the long-term quality of life for these patients. For patients who have undergone total resection of ...
On the afternoon of March 12, an innovative drug led by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, was launched.The launch meeting for the National Science and Technology Major Project on Drug Development, ” Research on Innovative Chemical Drugs for Anti-Alzheimer’s Disease Targeting New Mechanisms,” was held in Shanghai. This meeting was conducted strictly in accordance with the special project management standards, systematically deploying the project’s overall objectives, technical roadmap planning, task allocation, clinical research layout, and funding management throughout the entire process. (Wanbangde)(002082) The wholly-owned subsidiary Wanbangde Pharmaceutical Group, together with the project lead unit, cooperating research institutions and industry experts, gathered together to discuss the details of the project implementation and build consensus on research and development. Alzheimer’s disease is the most common type of dementia in clinical practice and also the most prevalent neurodegenerative disease. Its main manifestations include progressive decline in memory, judgment, ...
March 12 – Harscon Pharmaceutical…The company announced that on March 12, 2026, it learned that HSK31679 tablets were officially included in the “Breakthrough Therapy List” by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, making it the first THR-β agonist to be included in the Breakthrough Therapy List in China. Currently, no drugs are approved in China for the treatment of MASH (non-alcoholic steatohepatitis). The inclusion of HSK31679 tablets in the “Breakthrough Therapy List” will greatly promote the research and development of new drugs in this field and bring new hope for the treatment of MASH patients in my country. https://finance.eastmoney.com/a/202603123670377648.html
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