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Expanding Overseas Markets Again! Shengze Kanghua Ophthalmic Center’s IVD Products Receive TFDA Registration Certificate in Thailand

Guangdong Shengze Kanghua Biomedical Co., Ltd.’s self-developed ophthalmic IVD product has successfully passed the review of the Thai Food and Drug Administration (TFDA) and obtained the Thai medical device registration certificate , officially gaining approval to enter the Thai market! The approved products include: ✅ i-ImmunDx Analyzer ✅ Alpha-lymphotoxin (LTA) test kit ✅ Tear Total Immunoglobulin E (Total IgE) Detection Reagent ✅ Human matrix metalloproteinase 9 (MMP-9) detection reagent ✅ Micro-liquid collector Expanding overseas to create new opportunities From Europe to Southeast Asia, another key move has been made in the globalization strategy. This further expands the company’s international footprint. Previously, Shengze Kanghua’s comprehensive ophthalmic diagnostic solutions had been successfully implemented in several European countries , including the UK, Italy, and Spain, achieving stable commercial sales and gaining widespread recognition in overseas markets. Obtaining TFDA certification this time signifies the company’s successful expansion from Europe into the core Southeast Asian ...
- Source: drugdu
- 68
- May 27, 2026
Industry News | CSPC Pharmaceutical Group’s Budesonide Enteric-coated Capsules Receive Drug Registration Approval

On May 21, CSPC Pharmaceutical Group (1093.HK) announced that its budesonide enteric-coated capsules (4mg) (hereinafter referred to as “the product”) have obtained a drug registration certificate issued by the National Medical Products Administration of the People’s Republic of China. Budesonide is a corticosteroid with potent glucocorticoid activity and relatively weak mineralocorticoid activity, exhibiting extremely high first-pass metabolism. Budesonide inhibits the proliferation of mucosal B cells and their differentiation into plasma cells in the Peyer’s patchy lymph nodes of the ileum, thereby suppressing the production of galactose-deficient IgA1 antibodies (Gd-IgA1). It reduces the deposition of immune complexes in the glomerular mesangial area, leading to glomerulonephritis and decreased renal function, by reducing the formation of Gd-IgA1 antibodies and immune complexes in systemic circulation. This product is used to treat adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression to reduce renal function loss. Compared to other drugs, this ...
- Source: drugdu
- 71
- May 27, 2026
First! Gilead’s new hepatitis drug Hepcludex receives FDA approval

Recently, the FDA announced accelerated approval for Gilead Sciences’ Hepcludex (Bulevirtide-gmod) injection for the treatment of chronic hepatitis D virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis . This is the first FDA-approved therapy for the treatment of chronic HDV infection; previously, the FDA had granted it Breakthrough Therapy Designation and Orphan Drug Designation. This is not only the first FDA-approved therapy for chronic HDV infection, but also a key breakthrough in the global treatment of hepatitis D. Hepcludex was jointly developed by Gilead Sciences and MYR GmbH. In 2021, Gilead acquired MYR GmbH for approximately €1.45 billion, recognizing the immense potential of this world-first HDV attachment inhibitor. As an HDV attachment inhibitor targeting NTCP (sodium taurocholic acid cotransport peptide) , Hepcludex inhibits HDV infection by binding to the HDV receptor NTCP on the hepatocyte membrane, blocking the attachment of HDV to NTCP. Hepcludex first received marketing ...
- Source: drugdu
- 87
- May 27, 2026
A $7 billion nuclear medicine deal is imminent.

According to Bloomberg, Lantheus Holdings (LNTH), a company focused on radiopharmaceuticals, is evaluating a potential sale following a takeover offer from private equity-backed Curium Pharma . The offer values the radiopharmaceutical giant at approximately $7 billion , and if the deal goes through, it would be one of the most significant mergers and acquisitions in the global nuclear medicine field in 2026. Lantheus Holdings, headquartered in Massachusetts, USA, is one of the oldest companies in the radiopharmaceutical field, with its origins tracing back to New England Nuclear, founded in 1956. Over the decades, Lantheus has transformed from a traditional SPECT drug supplier into a platform company centered on PET radiodiagnostics . The company’s full-year revenue reached $1.54 billion in 2025, and its revenue for the first quarter of 2026 was $377.3 million. Lantheus’ flagship product, PYLARIFY (piflufolastat F 18) , was the world’s first radiodiagnostic drug to surpass $1 billion ...
- Source: drugdu
- 70
- May 27, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Japan?

Drugdu.com expert’s response: I. Mandatory Core Certifications MF (Master File) Registration Authority: Japan PMDA / Ministry of Health, Labour and Welfare (MHLW) Purpose: Full API technical dossier registration, linked review with Japanese pharmaceutical companies Requirement: Must be submitted through a domestic Japanese agent; valid for 5 years AFM (Approved Foreign Manufacturer) Designation Basis: Japan Pharmaceutical and Medical Device Act (PMD Act) Purpose: Legal export qualification for overseas API manufacturers Requirement: Renewed every 5 years; export prohibited without AFM Japan GMP Compliance (MHLW Ordinance No. 179) Basis: ICH Q7 + Japan GMP Method: PMDA on-site inspection Outcome: GMP Compliance Certificate, valid for 5 years II. Required Supporting Documents (Per Batch / Ongoing) Japanese domestic agent (responsible for submission, communication, and handling inquiries) GQP (Good Quality Practice) Quality Agreement (signed with Japanese MAH) Per-batch CoC (Certificate of Compliance) — batch number / specifications / test results / expiry date Certificate of Origin ...
- Source: drugdu
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- May 27, 2026
Good news! Asartan potassium tablets have been approved

Recently, Hefei Lifang Pharmaceutical Co., Ltd. received the Drug Registration Certificate for Mesartan Potassium Tablets ( 40mg , 80mg ) issued by the National Medical Products Administration . Mesartan potassium is a prodrug of the angiotensin II receptor blocker class. After oral absorption, it is rapidly converted into the active ingredient, azilsartan. The product for which marketing authorization is being applied is azilsartan potassium tablet, indicated for the treatment of essential hypertension in adults. The original manufacturer is Takeda Pharmaceutical Company Ltd. of Japan. The company’s esculent potassium API was approved for marketing in April 2026. The acquisition of the Drug Registration Certificate for esculent potassium tablets will further enrich the company’s product pipeline, enhance the company’s integrated industrial chain advantages in raw materials and formulations, and improve the company’s market competitiveness. https://mp.weixin.qq.com/s/GxAXMABZsxOGm0mvDJhsxg
- Source: drugdu
- 82
- May 26, 2026
Hisun Pharmaceutical’s prostate cancer treatment drug has been approved for market launch

Recently, Hisun Pharmaceutical announced that it has received a Drug Registration Certificate for apalutamide tablets (60mg) issued by the National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic endocrine therapy-sensitive prostate cancer (mHSPC) and adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) with a high risk of metastasis. According to the “Analysis of the Epidemiological Situation of Malignant Tumors in China in 2022” released by the National Cancer Center in 2024, the number of newly diagnosed prostate cancer cases reached 134,000, and the number of deaths reached 48,000, ranking sixth among male malignant tumors. As one of the most common malignant tumors in men, there is a strong market demand for apalutamide. According to IQVIA database statistics, global sales of apalutamide tablets are estimated at approximately US$5.202 billion in 2025, with domestic sales in China accounting for approximately US$85.7771 million. https://mp.weixin.qq.com/s/m2Q8h0C5A-yyIwBwEyudCw
- Source: drugdu
- 78
- May 26, 2026
Huadong Medicine’s first precision-targeting EGFR exon 21 (L858R) innovative drug, mefanilinib maleate (Mindray®), was prescribed for the first time nationwide

Recently, the first prescription of Mindray®, Huadong Medicine’s first precision-targeted EGFR exon 21 (L858R) innovative drug, was successfully issued at Shantou Central Hospital. This marks the official commercialization of Mindray® in China, propelling the treatment of non-small cell lung cancer (NSCLC) in my country into a new era of precision-targeted therapy and bringing new hope for survival to patients with locally advanced or metastatic NSCLC suffering from EGFR exon 21 (L858R) substitution mutations! Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of primary lung cancers. In my country, about 70% of NSCLC patients are diagnosed at an advanced stage, resulting in a low five-year survival rate. EGFR exon 21 (L858R) mutation is the major subtype of EGFR mutations, accounting for 35%-41%. Patients with exon 21 (L858R) mutations exhibit more specific clinical characteristics: older age, a higher proportion ...
- Source: drugdu
- 67
- May 26, 2026
Progen Pharmaceuticals’ metoprolol succinate extended-release tablets have received FDA approval in the United States for a new 25mg specification.

Recently, Zhejiang Jutai Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Progen Pharmaceuticals, received approval from the U.S. Food and Drug Administration (FDA) for a new 25mg PAS (Metoprolol Succinate Extended-Release Tablet) specification. This is another significant development following the FDA approval of the 50mg, 100mg, and 200mg specifications of the product in 2024, marking Progen Pharmaceuticals’ comprehensive multi-specification coverage of this core formulation in the U.S. market. Metoprolol succinate extended-release tablets are the world’s first selective β1 receptor blocker, which can reduce the risk of bronchoconstriction. It is widely used in the treatment of hypertension, angina pectoris, and symptomatic stable chronic heart failure with left ventricular systolic dysfunction, and is a commonly used drug in the field of chronic heart failure. Data shows that in 2025, the sales of this drug in the US market were approximately $233 million. The successful approval of the 25mg specification further improves the product ...
- Source: drugdu
- 64
- May 26, 2026
Japanese pharmaceutical giant ordered to pay 17 billion yen in damages.

A major ruling recently came from the U.S. District Court in Boston: Japanese pharmaceutical giant Takeda Pharmaceutical lost its first-instance case in a “pay-for-delay” antitrust lawsuit, with a federal jury ordering it to pay initial damages of $885 million . Under the triple damages clause of U.S. antitrust law, this fine could ultimately soar to approximately $2.5 billion (about 17 billion yuan) . ” Payment Delay ” agreements are a controversial business arrangement that has long existed in the pharmaceutical industry. The core logic is that when original drug manufacturers face patent challenges from generic drug manufacturers, they pay substantial compensation or share market profits in exchange for the generic drug manufacturers voluntarily abandoning their patent challenges and delaying the launch of their products. This case revolves around Takeda’s constipation treatment drug Amitiza (rubiprostone) . Developed by Sucampo and co-marketed by Takeda, the drug quickly became a blockbuster product after ...
- Source: drugdu
- 88
- May 26, 2026

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