PharmaFocus Today – Page 8 – media

AstraZeneca reports more good news

The hypertension drug market had been devoid of truly new mechanisms for many years. On May 18th, AstraZeneca’s Baxdrostat was approved for marketing in the United States, breaking this stagnation. As the world’s first aldosterone synthase inhibitor , it is not just a new drug, but a fundamental reshaping of the underlying logic of hypertension treatment. 01 Unraveling the “deadlock” of refractory hypertension Hypertension, as one of the most prevalent chronic diseases globally, has become the leading risk factor for cardiovascular and cerebrovascular diseases. Refractory hypertension, in particular, is the most challenging subtype, long troubling clinical diagnosis and treatment. According to the “Chinese Guidelines for the Prevention and Treatment of Hypertension (2023 Edition),” refractory hypertension refers to a condition where, despite lifestyle modifications, patients regularly take three or more antihypertensive drugs with different mechanisms of action (including diuretics), each at its maximum tolerated dose, and continue treatment for at least ...
- Source: drugdu
- 209
- May 21, 2026
A rising star in innovative drugs has had its product’s marketing application accepted.

According to the official website of the Center for Drug Evaluation of the National Medical Products Administration, the marketing application of Huadao (Shanghai) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Huadao Bio”) for its first Class 1 new drug, Wanji Aolunsai Injection, has been accepted . This drug is used to treat refractory and relapsed non-Hodgkin lymphoma. According to Insight database, Wanji Aolensai Injection was first applied for clinical trials in May 2018, and the first clinical trial results were announced five months later. This is the first marketing application for the drug. Currently, several CAR-T products have been approved for marketing globally. According to publicly available information, the average international price of these marketed products exceeds US$400,000, while the average domestic price is approximately RMB 1.2 million. These prices significantly exceed the out-of-pocket payment capacity and the affordability of medical insurance reimbursement for Chinese patients. Driven by the simple ...
- Source: drugdu
- 112
- May 21, 2026
UCB’s bicizumab is “exploding” as it targets AbbVie’s “autoimmune drug king”!

We are currently seeking innovative oral small molecule drugs in the field of innate immunity, with indications of inflammation or immunity. Drugs must have an Investigational New Drug (IND) application submitted in China or the US, or be in Phase I clinical trials. They should possess novel mechanisms, clearly defined targets, significant differentiation, clear intellectual property rights, and complete data to facilitate rapid clinical advancement. Interested pharmaceutical companies are welcome to contact the PharmaEdge BD team immediately! Bimzelx (bimzelumab) achieves four consecutive victories in head-to-head clinical trials for psoriasis! On May 19, 2026, UCB announced week 16 data from the BE BOLD trial. Results showed that in adult patients with active psoriatic arthritis (PsA), the IL-17A/F bispecific antibody bicizumab was superior to AbbVie’s Skyrizi in improving ACR50 joint outcomes . These results will be formally presented at the European Union of Rheumatology Societies (EULAR) annual meeting in London in early ...
- Source: drugdu
- 89
- May 21, 2026
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
- 76
- 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
- 132
- 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
- 128
- 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
- 120
- 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
- 105
- 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
- 180
- 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
- 108
- May 18, 2026

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