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Kanghua Biologics Faces Formidable Challenges in mRNA Vaccine Development

Chengdu Kanghua Biological Products Co., Ltd. (300841.SZ) recently filed an announcement stating that it plans to acquire 100% equity interest in Nameixin (Shanghai) Biotech Co., Ltd. (hereinafter referred to as “Nameixin”) in phases through capital increase, equity transfer and other means, thereby obtaining a complete mRNA technology platform and refining the strategic layout of its biopharmaceutical industry. “This transaction is essentially the layout of the mRNA vaccine industry by local state-owned asset investors through a listed company platform,” a pharmaceutical industry expert in Beijing told reporters from the Economic Information Daily on February 1st. Despite the transaction plan incorporating investment risk hedging measures, two major risks cannot be underestimated: first, LNP (Lipid Nanoparticle) patents form the core bottleneck in the industrialization of mRNA technology, and these patents are held by international giants such as Canada-based Arbutus Biopharma; if Nameixin fails to break through these patent barriers, the entire investment rationale ...
- Source: drugdu
- 42
- February 6, 2026
【EXPERT Q&A】Can the registration and access of medical device products in Brazil be accelerated if they already have FDA and CE certifications?

Drugdu.com expert’s response: Medical devices that have obtained FDA and CE certifications can expedite registration and market access in Brazil, primarily reflected in simplified review processes, reduced redundant testing, and shortened approval cycles. The specific acceleration mechanisms and operational points are as follows: I. Acceleration Mechanisms: ANVISA’s Recognition of International Certifications The Brazilian National Health Surveillance Agency (ANVISA) explicitly allows referencing international authoritative certification results (e.g., FDA, CE) to streamline registration processes. According to ANVISA’s IN 290/2024 directive: 1. Technical Document Mutual Recognition If a product has obtained FDA or CE certification, ANVISA may directly adopt its technical evaluation results (e.g., design validation, performance testing, biocompatibility), minimizing redundant reviews. For example, clinical data and risk assessment reports (ISO 14971) from CE certification can be directly used to support Brazilian registration, avoiding resubmission. 2. On-Site Audit Exemption For Class III and IV high-risk devices, if a company holds an MDSAP (Medical ...
- Source: drugdu
- 41
- February 6, 2026
Aligning with international standards! Aidea Pharma obtains Tanzania’s ML3 GMP certification

Recently, Jiangsu Aidea Pharmaceutical Group (stock code: 688488.SH) announced that it has officially received a GMP certificate for pharmaceuticals issued by the Tanzania Medicines and Medical Devices Authority (TMDA). This is the first GMP certificate approved by the World Health Organization (WHO) Maturity Level 3 (ML3) regulatory agency for Aidea Pharmaceutical, signifying that the company’s quality management system and production standards meet international requirements and creating favorable conditions for expanding into the African market. The World Health Organization’s Global Benchmarking Tool (GBT) classifies the maturity of national drug regulatory agencies into four levels, from ML1 to ML4, from low to high. ML3 represents a “stable, well-functioning, and integrated” drug regulatory system, possessing systematic and internationally standardized operational capabilities in key areas such as marketing authorization, GMP inspections, and post-market surveillance. As of the end of 2025, only a few institutions in Africa, such as Tanzania’s TMDA, have reached the ML3 ...
- Source: drugdu
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- February 5, 2026
Shijiazhuang Pharmaceutical Group’s clopidogrel emulsion injection has received a drug registration certificate.

On February 2, CSPC Pharmaceutical Group (1093.HK) announced that its clovidipine emulsion injection (50ml:25mg, 100ml:50mg) (hereinafter referred to as “the product”) has obtained a drug registration certificate issued by the National Medical Products Administration of the People’s Republic of China.This product is a dihydropyridine calcium channel blocker, a rapid-acting intravenous antihypertensive drug, suitable for treating hypertensive patients who are unsuitable for oral medication or whose oral medication is not expected to be effective. Compared with commonly used clinical drugs, this product has the following significant advantages: faster onset of action, enabling rapid, real-time, and precise blood pressure control; more suitable for patients with abnormal liver and kidney function, requiring no dosage adjustment during treatment; and no dilution or preparation required, significantly benefiting individuals at risk of fluid overload. The approval of this product will further enrich the Group’s product pipeline in the field of cardiovascular and cerebrovascular disease treatment, enhance ...
- Source: drugdu
- 54
- February 5, 2026
Human Coagulation Factor IX Drug Registration and Marketing Authorization Application Accepted

February 4th – Parlin Biotechnology announced on February 4 that its wholly-owned subsidiary, Guangdong Shuanglin Biopharmaceutical Co., Ltd., recently received the “Acceptance Notice” for the drug registration and marketing authorization of human coagulation factor IX issued by the National Medical Products Administration. The indications for human coagulation factor IX are: to treat hemophilia B patients with congenital human coagulation factor IX deficiency or patients with low levels of human coagulation factor IX due to other reasons, it can significantly increase the level of human coagulation factor IX in their blood, thereby achieving the purpose of preventing and treating bleeding. https://finance.eastmoney.com/a/202602043641469948.html
- Source: drugdu
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- February 5, 2026
HX111 completes first patient dosing in Phase I clinical trial

On February 4, Hansit Aite (03378) announced that it has launched a Phase I clinical trial of its self-developed candidate drug HX111 for refractory lymphoma and solid tumors, and has recently successfully completed the enrollment and dosing of the first patient. HX111 can bind to OX40 molecules on the surface of tumor cells with high affinity and high specificity. After entering tumor cells via endocytosis, it releases a powerful payload by lysosomal protease cleavage of the linker, thereby inducing tumor cell apoptosis. The company’s HX111 is the world’s first publicly disclosed OX40-targeted ADC drug to enter the clinical stage. This field is still in the early exploration stage and is expected to fill the gap in the treatment of this type of tumor. https://finance.eastmoney.com/a/202602043641684563.html
- Source: drugdu
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- February 5, 2026
When the 31-valent pneumococcal vaccine begins Phase 3 clinical trials

When Vaxcyte pushed its 31-valent pneumococcal conjugate vaccine VAX-31 into Phase III clinical trials, a vaccine race surrounding ” valence ” has entered a heated phase. 01 The debate over technological approaches The core of market competition in the field of pneumococcal vaccines lies in technological innovation breakthroughs. Traditional multivalent pneumococcal vaccines have consistently faced the dilemma of simultaneously increasing valence and enhancing immunogenicity during their development. Increased valence is often accompanied by a decline in immunogenicity, becoming a key bottleneck for the industry’s development. The core regulatory factor in this dilemma is the biological characteristics of the carrier protein. In the structural system of pneumococcal conjugate vaccines, the carrier protein plays a core role in mediating polysaccharide antigen presentation and activating the body’s immune response. However, under traditional technical approaches, high-valent pneumococcal vaccines rely on higher doses of carrier proteins to achieve multi-serotype antigen conjugation. The immunosuppressive effect of ...
- Source: drugdu
- 48
- February 5, 2026
Eli Lilly invests 24.3 billion yuan more in weight-loss drugs

Eli Lilly recently announced plans to invest over $3.5 billion (approximately RMB 24.3 billion) to build a new manufacturing facility for injectable drugs and medical devices in Lehigh Valley, Pennsylvania, USA. Construction is expected to begin in 2026, with production commencing in 2031. Eli Lilly ‘s next-generation weight loss drug, Retatrutide. This is a world-first GIP/GLP-1/glucagon (GCGR) triple-target receptor agonist , considered a next-generation product following the dual-target drug telpotetide. Compared to single-target (such as semaglutide) or dual-target drugs currently on the market, retaglutide achieves a qualitative leap in weight loss by simultaneously activating three incretin receptors . Phase III clinical trial data released in December 2025 showed that participants achieved an average weight loss of 28.7% over 68 weeks , setting a new record for published clinical trial data. Retaglutide is currently in Phase III clinical trials and is expected to be launched by the end of 2026 or ...
- Source: drugdu
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- February 5, 2026
MedtecLIVE

Organiser：Informa Time：May 5 – 7, 2026 Address：Messepiazza 1, 70629 Stuttgart, Stuttgart Germany Exhibition hall： Messe Stuttgart Product range: Precision Instruments: Professional medical alloys, microprocessors, computer numerical control (CNC), ultrasound and laser technologies, surgical equipment, medical accessories for interventional cardiac devices and surgical techniques Medical Plastic Technologies: Medical classification of plastic raw materials, outsourcing and processing of medical consumables, packaging, and drug delivery services Automation Equipment Technologies: Automated production processes related to automation settings, assembly processes, and robot motion control Pharmaceutical Packaging: Packaging solutions ranging from filling processes to packaging materials, and from manufacturers of disposable products to outsourcers About MedtecLIVE ： MedtecLIVE, the Germany Medical Device and Medical Technology Exhibition, is the most authoritative medical device and medical technology exhibition in Europe. This conference has become the second-largest global conference in the medical device industry, meeting the needs of medical device product designers and professionals in medical device manufacturing. ...
- Source: drugdu
- 43
- February 5, 2026
Obtains Drug Registration Certificate for Vitamin K1 Injection

China Securities Intelligent Finance News Yifan Pharmaceutical(002019) announced on February 3 that its wholly-owned subsidiary, Hefei Yifan Biopharmaceutical Co., Ltd., received vitamin approval and certification from the National Medical Products Administration on January 30, 2026.K1 Injection Drug Registration Certificate According to the announcement, the approved vitamin K1 injection solution has a specification of 1ml:10mg and is suitable for adults and children over 1 year old. It is used to treat vitamin K deficiency bleeding and prevent vitamin K deficiency that cannot be addressed through nutritional supplementation. According to data from Menet.com, the domestic sales of vitamin K1 injection solution in 2023 reached 593 million yuan. To date, several companies in China have received approval for this drug. Our company is one of two companies whose products are micellar formulations and are considered to have passed the generic drug consistency evaluation. Several other companies have generic versions under review for approval. ...
- Source: drugdu
- 56
- February 4, 2026

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