media – Page 17 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

API Is Not Just a Cost – It’s Your Ticket to Global Markets

How serious buyers actually screen suppliers For professional buyers, a complete COA and a clear GMP certificate set often carry more weight than the numbers on a quotation sheet. In many export projects, Active Pharmaceutical Ingredients (APIs) are still treated as “standard items”: available stock, basic documents, acceptable price – and the box is ticked. However, Drugdu.com’s trade data show a clear divide: suppliers that consistently receive high-quality inquiries and progress into registration and tender stages are the ones that treat APIs as the first piece of the supply chain, not just a cost element. When global buyers evaluate a new project, this is usually where they start. 01. Why is the API the “first piece”? The API is the source of pharmacological activity, but its role in regulatory and commercial decision-making is much broader. Each API comes with a full “identity profile”: CAS number, molecular structure, purity, impurity profile, ...
- Source: drugdu
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- March 3, 2026
BioPharma Expo Tokyo

Organiser：Reed Exhibitions Time：May 20 – 22, 2026 Address：3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: Biologic Drug Development: Monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific antibody platforms Cell & Gene Therapy: iPSC technology, viral vector production equipment, gene delivery systems CDMO Services: Flexible production lines and compliance solutions presented by Japan’s top CMOs Digital Tools: AI-driven drug discovery software, intelligent manufacturing MES systems About BioPharma Expo Tokyo： BioPharma Expo Tokyo is one of the largest pharmaceutical laboratory and bioresearch technology exhibitions in Asia. It covers R&D technologies, manufacturing technologies, and contract services, attracting global visitors, exhibitors, and professionals in the biopharmaceutical sector. Japan has become the world’s second-largest investor in R&D for the biopharmaceutical industry, and the world’s third-largest pharmaceutical and biotechnology market after the United States and China. With the rapid growth of the global biopharmaceutical industry, Japan continues to play ...
- Source: drugdu
- 118
- March 3, 2026
Rovaxitinib approved for marketing, filling the demand for myelofibrosis treatment

On March 2, China Biopharmaceutical (01177) issued an announcement stating that the group’s independently developed Class 1 innovative drug…Rovaxitinib tablets (trade name: Anxu®) have been approved for marketing by the National Medical Products Administration (NMPA) of China for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). In a multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled phase II clinical trial, rovaxitinib demonstrated superior efficacy and good safety compared to hydroxyurea in the treatment of intermediate-2 and high-risk myelofibrosis patients. The results showed that in the rovaxitinib group, 58.33% of subjects achieved a spleen volume reduction of ≥35% from baseline (SVR35) at week 24, 63.89% achieved SVR35 at any time point, the mean duration of SVR35 was as long as 8.31 months, and the best total symptom score improvement of ≥50% (TSS50) rate was as high as 77.78%. The ...
- Source: drugdu
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- March 2, 2026
Warrant Pharmaceuticals’ active pharmaceutical ingredient receives Brazil’s first official GMP certification

Warrant Pharmaceuticalsraw materialsAnother piece of good news for our business segment. Recently, our wholly-owned subsidiary, Hunan Huana Pharmaceutical Chiral Drugs Co., Ltd., received a Good Manufacturing Practice (GMP) certification from the Brazilian National Health Surveillance Agency (ANVISA). This marks the first time our API (Active Pharmaceutical Ingredient ) business segment has passed an official audit in Brazil, signifying that our quality management and production systems continue to meet high international standards and laying a solid foundation for further expansion into the international market. The product undergoing official audit in Brazil is fosfomycin tromethamine. It is the raw material for fosfomycin tromethamine powder and other formulations, which are mainly used to treat acute uncomplicated urinary tract infections and asymptomatic bacteriuria caused by susceptible Escherichia coli, Enterococcus faecalis, Klebsiella pneumoniae, Citrobacter spp., Enterobacter spp., and Proteus mirabilis. During the five-day inspection, Brazilian auditing officials conducted a comprehensive audit of the company’s active ...
- Source: drugdu
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- March 2, 2026
Merck’s New Story

Merck has made a change, recently announcing adjustments to its pharmaceutical business organizational structure and confirming a new head of the business. This organizational restructuring, ostensibly a rearrangement of business lines, is actually aimed at addressing the impending patent cliff for Keytruda and defending its position as the leading oncology drug. 01 Announcement of important adjustments Originally, Merck’s organizational structure was divided into two main segments: human health (i.e., pharmaceutical business) and animal health. The human health business included nine sub-segments: oncology, vaccines, hospital emergency care, cardiovascular, metabolic and respiratory, virology, neuroscience, immunology, metabolism, and others. Merck has now restructured its human health business, consolidating its previously fragmented business lines into two strategic clusters: Oncology and Specialty (Specialty Drugs), and General Drugs and Infectious Diseases. This signifies that Merck is reshaping its market competitiveness through resource focus and synergistic effects. This new round of organizational restructuring marks a new stage ...
- Source: drugdu
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- March 2, 2026
Rongchang Biotechnology has turned a profit!

Recently, Rongchang Biotechnology released its preliminary financial results for 2025. Annual revenue reached 3.25 billion yuan, an increase of 89.36% year-on-year; net profit attributable to owners of the parent company was 710 million yuan, a turnaround from a loss of 1.468 billion yuan in 2024. Rongchang Bio stated that the significant year-on-year increase in the company’s operating revenue was mainly due to the increased domestic sales volume and revenue of its core products, Telitacicept and Vidicetumab , which became the core growth engine for its performance. At the same time, the company successfully reached a major cooperation agreement , resulting in a significant increase in technology licensing revenue. In June 2025, Rongchang Bio granted Telitacicept a paid license to Vor Bio. Under the agreement, Rongchang Bio will receive $125 million in cash and warrants from Vor Bio (including a $45 million upfront payment and $80 million in warrants, representing approximately ...
- Source: drugdu
- 70
- March 2, 2026
Jiuyuan Gene’s “Simeglucopyranoside” for weight loss (Jikeqin®) has been submitted for market approval

On February 26 , Jiuyuan Gene announced that its marketing authorization application for Jikeqin® has been formally accepted by the National Medical Products Administration ( NMPA ) . The indication for this application is weight management in obese or overweight individuals . Jikeqin® is a biosimilar of smegglutide , a long-acting glucagon-like peptide -1 ( GLP-1 ) receptor agonist developed by Jiuyuan Gene, and is being submitted under Class 3.3 of the biological drug registration category . Glucose® improves blood sugar control and achieves weight management by mimicking the physiological effects of endogenous GLP-1 hormones, promoting insulin secretion, inhibiting glucagon release, suppressing appetite, and delaying gastric emptying. In the ongoing Phase III clinical trial, Jikeqin® underwent a randomized, open-label, positive-controlled, parallel-design clinical equivalence study in obese subjects. The results showed that it was clinically equivalent to the reference drug in terms of the primary efficacy endpoint ( the rate of ...
- Source: drugdu
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- March 2, 2026
【EXPERT Q&A】What factors should be given priority consideration in the benefit-risk assessment of medical devices?

Drugdu.com expert’s response: The benefit-risk assessment of medical devices is a core aspect of ensuring their safety and effectiveness, requiring systematic analysis based on scientific evidence and regulatory requirements. Below are the key considerations and detailed explanations: I. Core Evaluation Dimensions 1. Benefit Factors Clinical Efficacy Disease diagnostic accuracy (e.g., sensitivity, specificity). Therapeutic effectiveness (e.g., cure rates, symptom relief rates). Contribution to public health (e.g., infectious disease screening, epidemic prevention and control). Patient Benefits Improved quality of life (e.g., pain reduction, restored mobility). Extended survival (e.g., early cancer diagnostic devices). Reduced complications or need for secondary interventions (e.g., minimally invasive surgical instruments). Social Value Optimized healthcare resources (e.g., rapid diagnostic devices shortening diagnosis time). Promotion of healthcare equity (e.g., low-cost basic diagnostic tools). 2. Risk Factors Device-Related Risks Design flaws: e.g., allergic reactions due to poor material biocompatibility. Performance instability: e.g., low reproducibility of results from diagnostic devices. Operational complexity: ...
- Source: drugdu
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- March 2, 2026
a full look at 15 blockbuster drugs.

2026 is destined to be an extraordinary year in the history of anti-tumor drug research and development in China. According to statistics from the DXY Insight database, 34 new anti-tumor drugs are expected to be approved for marketing in China for the first time this year, of which 15 have been included in the priority review list by the CDE (Center for Drug Evaluation). From ADCs to CAR-T, from bispecific antibodies to next-generation kinase inhibitors, domestically produced and imported innovative drugs are competing on the same stage, reshaping the future landscape of cancer treatment in China. Table: 15 New Anti-tumor Drugs Expected to be Approved in China by 2026 6740572573824ed6d0b2ac201395c2b5.png 01 Diverse Technological Breakthroughs: From “Targeted” to “Intelligent” The most significant feature of the 15 blockbuster anti-tumor drugs approved in 2026 is the diversified breakthroughs in technological approaches. This has completely broken the traditional limitations of anti-tumor drug development based ...
- Source: drugdu
- 149
- February 28, 2026
EMA CHMP Recommends EU Approval of Henlius’ Pertuzumab Biosimilar HLX11

Shanghai, China, February 27, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for HLX11 (trade name in U.S.: POHERDY), a biosimilar candidate to Perjeta® (pertuzumab) independently developed by Henlius. The positive opinion recommends approval of HLX11 for all indications approved for the reference product in the European Union, covering HER2-positive early and metastatic breast cancer. The positive CHMP opinion marks a significant regulatory milestone for HLX11 in Europe and supports the potential future availability of the products to patients across the region, subject to European Commission approval. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The positive CHMP opinion for HLX11 represents another important advancement in Henlius’ global strategy. It not only underscores our strong capabilities in international ...
- Source: drugdu
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- February 28, 2026

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