PharmaFocus Today – Page 16 – media

Mabwell Bio announced that its supplemental application for an additional indication for Mabwelljian® (denosumab injection) has been approved

Mabwell Biopharmaceutical (688062.SH, 02493.HK), an innovative biopharmaceutical company with a full-industry-chain layout, announced that its wholly-owned subsidiary, Taikang Biopharmaceutical, has received approval from the National Medical Products Administration for its supplemental application to add the indications for bone metastases of solid tumors and multiple myeloma (for the treatment of patients with bone metastases of solid tumors or multiple myeloma to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiotherapy or bone surgery) for its independently developed Mabwelljian® (Denosumab injection, R&D code: 9MW0321) . Mabwelljian® is the first denosumab biosimilar (120mg) to be approved for marketing in China. It was first approved in March 2024 for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection would result in severe functional impairment, including adults and skeletally mature (defined as at least one mature long bone and a weight ≥45kg) adolescents. ...
- Source: drugdu
- 127
- May 21, 2026
World’s First! Kelun-Biotech/Merck TROP2 ADC Achieves Dual Positive Phase III Results in Endometrial Cancer

On May 18, 2026, global pharmaceutical giant Merck (MSD) and China’s Kelun-Biotech jointly announced that their collaboratively developed TROP2-targeting antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT, brand name: Jatai®), met its primary endpoints in a global Phase III clinical trial (TroFuse-005) for advanced or recurrent endometrial cancer. This is the world’s first ADC therapy to simultaneously demonstrate statistically significant improvements in both overall survival (OS) and progression-free survival (PFS) in endometrial cancer patients who have progressed after platinum-based chemotherapy and immunotherapy, breaking the long-standing treatment gap for this difficult-to-treat patient population. Milestone Breakthrough: First OS/PFS Dual-Positive Phase III Data According to pre-specified interim analysis results, sac-TMT demonstrated statistically significant and clinically meaningful improvements in both primary endpoints of OS and PFS, significantly superior to the physician’s choice chemotherapy (doxorubicin or paclitaxel). The study also successfully met the key secondary endpoint of objective response rate (ORR). This randomized, open-label, multicenter global Phase ...
- Source: drugdu
- 202
- May 19, 2026
A New Treatment Option for Pulmonary Fibrosis! Boehringer Ingelheim’s New Drug Approved

On May 18, 2026, Boehringer Ingelheim announced that the Japanese Ministry of Health, Labour and Welfare had approved JASCAYD (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in adults . According to the press release, JASCAYD® is the first PDE4B inhibitor approved for the relevant indication, possessing both anti-fibrotic and immunomodulatory effects, providing a new treatment option for patients with IPF and PPF.Idiopathic pulmonary fibrosis and progressive pulmonary fibrosis are rare and difficult-to-cure diseases with limited treatment options. The approval of JASCAYD is a major achievement with the potential to revolutionize the treatment paradigm for these diseases.JASCAYD® possesses a novel mechanism of action, exerting anti-fibrotic and anti-inflammatory effects in the lungs, demonstrating a slowing effect on the decline of lung function in both FIBRONEER-IPF™ and FIBRONEER-ILD™. Furthermore, a meta-analysis of these trials showed a nominally significant reduction in the risk of death.The approval of ...
- Source: drugdu
- 192
- May 19, 2026
A world first! AstraZeneca’s new hypertension drug approved for market launch.

On May 18, AstraZeneca announced that its baxdrostat (trade name: Baxfendy) has been approved in the United States as the first aldosterone synthase inhibitor (ASI) to be used in combination with other antihypertensive drugs to treat hypertension and lower blood pressure in adults with poorly controlled blood pressure. The product was submitted for market approval in China in February of this year. Source: AstraZeneca official website Baxdrostat is a first-in-class, highly selective aldosterone synthase inhibitor that lowers blood pressure by inhibiting aldosterone production. In February 2023, AstraZeneca acquired CinCor for $1.8 billion, gaining access to Baxdrostat . In December 2025, AstraZeneca submitted a marketing application for the product to the FDA and was granted priority review status, allowing it to be used as adjunctive therapy to other antihypertensive drugs in cases where these drugs fail to adequately lower blood pressure, for the treatment of adult patients with refractory hypertension (uncontrolled ...
- Source: drugdu
- 204
- May 19, 2026
Bio-Thera Solutions and Accord BioPharma jointly announced that the first golimumab biosimilars for Simponi®/Simponi Aria®, IMMGOLIS™ and IMMGOLIS INTRI™, have been approved by the U.S. FDA.

Bio-Thera Solutions, Ltd. (Stock Code: 688177 ) is a global biopharmaceutical company headquartered in Guangzhou, China, based on scientific innovation . Recently, the Company and Accord BioPharma (hereinafter referred to as ” Accord ” , a US subsidiary of Intas Pharmaceuticals focusing on the development of oncology, immunology, and central nervous system therapies) jointly announced that they have received notification from the US Food and Drug Administration ( FDA ) that two biosimilars developed by Bio-Thera, based on simponicity® golimumab ( BAT2506 ) – IMMGOLIS ™ ( golimumab-sldi ) (subcutaneous injection) and IMMGOLIS INTRI™ ( golimumab-sldi ) (intravenous infusion) – have received FDA approval for marketing in the United States. Among them, IMMGOLIS™ is approved for use in combination with methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis and for the treatment of adult patients with moderate to severe active ulcerative colitis; IMMGOLIS INTRI™ ...
- Source: drugdu
- 157
- May 19, 2026
This Time, VBP May Be Unavoidable

The 12th round of national Volume-Based Procurement (VBP) is underway, and Entresto (sacubitril/valsartan), familiar to many hypertension and heart failure patients, is once again being targeted after a narrow escape from last year’s procurement list. On May 15, Shanghai Sunshine Procurement Network published the “Announcement on Pre-filing of Drug Information for National Volume-Based Procurement.” This round includes 77 varieties for pre-filing, totaling 233 specifications — the largest scale in history. Among the varieties listed for pre-filing are several blockbuster drugs with annual sales of billions of RMB, including the immunosuppressant tacrolimus, the antiplatelet drug indobufen, and the antibiotic ceftazidime-avibactam. Most notably, sacubitril/valsartan sodium tablets — better known to hypertension patients as “Entresto” — has drawn the most attention. “Entresto” was developed by Novartis. It is the world’s first angiotensin receptor-neprilysin inhibitor (ARNI), with dual effects of lowering blood pressure and protecting the heart. It first entered the Chinese market in ...
- Source: drugdu
- 377
- May 18, 2026
The Pure Generic Drug Giant No Longer Exists

A new wave of upheaval and transformation has long since begun. Sun Pharmaceutical, India’s largest generic drugmaker, is acquiring Organon for $117.5 billion — the largest overseas acquisition in Indian pharmaceutical history — revealing the anxiety gripping the generic drug industry. With buyer consolidation in the U.S. market, persistent pricing pressure, and intensifying competition, even global generic giants are being swept along by industry trends, saying goodbye to the era of “easy money” in generics. As Sun Pharma Chairman Dilip Shanghvi stated, ‘This is a critical step in our strategic transformation. Organon’s specialty drug assets will help us escape the quagmire of generic price wars and build a sustainable growth engine.’ Before Sun Pharma, another generic giant, Teva Pharmaceutical, had already staged a turnaround through innovation-driven transformation, with its stock rising nearly 240% since 2024. These signals collectively point to a fact: the global generic drug industry is undergoing a ...
- Source: drugdu
- 155
- May 18, 2026
Ten departments, including the State Administration of Traditional Chinese Medicine, are cracking down on illegal and irregular practices related to traditional Chinese medicine.

Recently , ten departments, including the State Administration of Traditional Chinese Medicine, jointly convened a meeting to launch a special campaign to address illegal and irregular practices in traditional Chinese medicine (TCM) medical practice. This year-long campaign will severely crack down on illegal medical practices under the guise of TCM health preservation and disease treatment, false advertising and live-streaming sales using the name of TCM, and illegal use of medical insurance funds, among other illegal and irregular activities that harm the health rights of the public. In the short term, some small and medium-sized TCM institutions and health preservation companies that rely on false advertising, illegal medical practice, and illegal insurance fraud will face closure and penalties, and related concept stocks may experience a short-term correction, impacting market sentiment to some extent. However, in the long term, the special campaign will eliminate the “bad apples” in the industry, break the ...
- Source: drugdu
- 121
- May 18, 2026
Breaking News! Results of Two Studies on Smegglutinin Announced

The 33rd European Congress on Obesity (ECO 2026) was recently held in Istanbul, Türkiye. Novo Nordisk unveils two key data points: Higher doses of Wegovy injection (semaglutide 7.2 mg) resulted in nearly 28% weight loss in early responders; Wegovy oral tablets achieved a 21.6% weight loss and significantly improved physical activity in early responders. These two sets of data indicate that smegglutide has the best performance in its class in terms of comprehensive benefits such as weight loss, muscle health improvement, and improved mobility. 01 STEP UP subgroup analysis: Higher doses offer weight loss advantages The STEP UP trial was a 72-week, randomized, double-blind, parallel-group, placebo-controlled superiority trial designed to evaluate the efficacy and safety of semaglutide 7.2 mg as an adjunct to lifestyle interventions compared to semaglutide 2.4 mg and placebo. The trial enrolled over 1400 obese adults without type 2 diabetes. A recent subgroup analysis showed that, regardless ...
- Source: drugdu
- 138
- May 18, 2026
Synermore Biotech Receives Another International GMP Certification; Innovative Monoclonal Antibody Drug Cribi® Accelerates Global Expansion

On May 11, 2026, Synermore Biopharmaceutical (Suzhou) Co., Ltd. (“Synermore Biopharmaceutical”) announced that it had officially received the Good Manufacturing Practice (GMP) certificate issued by the Philippine Food and Drug Administration (FDA Philippines) . This is Synermore Biopharmaceutical’s second overseas GMP certification , following its acquisition of the Turkish GMP certificate at the end of 2025. This signifies that the production quality management system of its core product, Zamerovic-Mazoprevir Injection (trade name: Cribi®), continues to be recognized by overseas regulatory agencies, further accelerating its internationalization process. GMP certificate issued by the Philippine Food and Drug Administration (FDA Philippines) Krebi® is a Class I innovative drug independently developed by Synermore Biotechnology, used for passive immunization in adult individuals exposed to rabies virus. It is the first domestically produced anti-rabies cocktail monoclonal antibody that meets the recommendations of the World Health Organization (WHO) and was approved for marketing by the China National ...
- Source: drugdu
- 129
- May 18, 2026

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