PharmaFocus Today – Page 6 – media

Sinovac Biotech and Changzhou Pharmaceutical Factory have reached a strategic cooperation agreement and signed an exclusive licensing agreement for two cardiovascular drugs in overseas markets.

Recently, Sinovac BiotechSinovac Biotech Co., Ltd. (hereinafter referred to as ” Sinovac Biotech”)(Stock code 688136.SH) and Shanghai PharmaceuticalsChangzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as “Changzhou Pharmaceutical Factory”), a subsidiary of the Group, held a strategic cooperation signing ceremony and an exclusive licensing agreement for two products, ticagrelor tablets and rosuvastatin calcium tablets, in several European countries. Leveraging Sinovac Biotech ‘s mature overseas commercialization network and Changzhou Pharmaceutical Factory’s high-quality product R&D and manufacturing capabilities, the two parties will join hands to expand into the European market, bringing domestically produced cardiovascular drugs to more patients. Enriching the European product line and continuously cultivating the major market It is understood that both products launched through this collaboration have been approved in China and the United States and are currently undergoing registration applications in several European countries. The cooperation covers markets including Germany, Spain, the Netherlands, Italy, and France. Ticagrelor tablets ...
- Source: drugdu
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- March 31, 2026
Bayer’s fenelitonee has been approved in the European Union for use in adult patients with heart failure with LVEF ≥ 40%.

Based on the positive results of the Phase III FINEARTS-HF study, the European Union approved fenelone for patients with heart failure with a left ventricular ejection fraction (LVEF) ≥40%. The study included approximately 6,000 patients with various types and conditions of heart failure with LVEF ≥40%. Fennellone is the first mineralocorticoid receptor antagonist to demonstrate definite cardiovascular benefits in a phase III clinical trial in patients with heart failure and LVEF ≥ 40%. More than 15 million people in Europe suffer from heart failure, of whom about 50% have an LVEF ≥ 40%. Currently, there are limited approved treatment options for this group that meet guideline recommendations, and the risk of cardiovascular events remains high. On March 30, 2026, Bayer announced that the European Commission approved the selective nonsteroidal mineralocorticoid receptor antagonist fenelazor (Cosminda®) for the treatment of adult patients with heart failure with a left ventricular ejection fraction (LVEF) ...
- Source: drugdu
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- March 31, 2026
World’s first! Amgen/AstraZeneca’s blockbuster drug approved for marketing in China

On March 27, the NMPA website showed that terzafimumab injection, a TSLP monoclonal antibody jointly submitted by AstraZeneca and Amgen , was approved for marketing. The drug was approved for two indications: asthma (application number: JXSS2400102/3) and chronic sinusitis with nasal polyps (application number: JXSS2500019/20) . Screenshot source: NMPA official websiteTezaliumab, developed in collaboration between AstraZeneca and Amgen, is a first-in-class human monoclonal antibody that inhibits the action of TSLP. TSLP is a key epithelial cytokine located at the top of multiple inflammatory cascades and is closely associated with allergic, eosinophilic, and other types of endothelial inflammation related to severe asthma and other inflammatory diseases.In 2021, the drug was first approved by the FDA for adjunctive maintenance therapy in adults and children aged 12 years and older with severe asthma . In 2022, it was approved in the European Union and Japan. In October 2025, the drug was approved for a new indication in the United States for maintenance therapy of poorly controlled chronic sinusitis with ...
- Source: drugdu
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- March 31, 2026
Progen Pharmaceuticals’ ephedrine sulfate injection has received exclusive approval, empowering perioperative blood pressure management.

Recently, Zhejiang Procon Pharmaceutical Co., Ltd., a subsidiary of Procon Pharmaceuticals, received exclusive approval for its ephedrine sulfate injection, which is considered to have passed the consistency evaluation. As a blockbuster drug that was exclusively applied for and approved in China, the successful launch of this product not only enriches the company’s anesthetic drug product line, but also fills the clinical gap for ephedrine preparations that can be administered intravenously and are suitable for various anesthetic environments, providing a more standardized and reliable new medication option for patients with perioperative hypotension. Perioperative hypotension is one of the most common complications in clinical anesthesia. According to data from the China Health Statistics Yearbook (2024 Edition), the number of surgeries in my country reached 96.39 million in 2023, with an incidence of hypotension during anesthesia as high as 93%, which is estimated to be nearly 89.64 million cases per year. Clinical demand ...
- Source: drugdu
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- March 31, 2026
The super-big drug race has been upgraded again

Autoimmune diseases have become the second largest pharmaceutical market globally after oncology, with the psoriasis drug segment being particularly prominent, having given birth to multiple “blockbuster drugs” with staggering sales. Although market competition has intensified, the field is undergoing a new round of optimization and upgrading driven by innovative therapies. The treatment of psoriasis has evolved from tumor necrosis factor (TNF) inhibitors (e.g., Humira) to interleukin (IL) inhibitors (e.g., Stelara, Skyrizi), and further to oral small-molecule targeted drugs (e.g., PDE4 inhibitors, JAK inhibitors). Leveraging a large patient population, these drugs have generated cumulative sales exceeding one hundred billion dollars. Currently, psoriasis treatments present a diversified landscape, with validated targets such as JAK, IL-17, IL-23, and TYK2 being focal points of R&D amid fierce competition. Numerous domestic pharmaceutical companies are also actively engaging in follow-up research and development in areas like IL-23, IL-17A/F dual-target, and PDE4 inhibitors, with some products already ...
- Source: drugdu
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- March 31, 2026
The first in nearly 20 years! The FDA has approved the marketing of this innovative drug

Recently, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Denali Therapeutics’ innovative drug Avlayah (tividenofusp alfa) for the treatment of Hunter syndrome (Mucopolysaccharidosis II). This approval marks a dual breakthrough: it is not only the first new treatment option for this disease in nearly 20 years but also the first FDA-approved enzyme replacement therapy that utilizes a transferrin receptor-mediated mechanism to cross the blood-brain barrier. Hunter syndrome is a rare genetic lysosomal storage disorder caused by a deficiency of the enzyme iduronate-2-sulfatase (IDS), leading to abnormal accumulation of glycosaminoglycans throughout the body’s cells, with particularly severe damage to the central nervous system. While traditional enzyme replacement therapies can improve peripheral symptoms, they cannot effectively cross the blood-brain barrier and therefore fail to halt neurological decline. The key innovation of Avlayah lies in its TransportVehicle™ (TV) platform technology. This engineered technology enables the drug to bind to transferrin ...
- Source: drugdu
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- March 31, 2026
Say goodbye to lifelong IV drips! FDA approves first in vivo gene therapy for infantile Pompe disease

Abstract: Rocket Pharma announced that its in vivo gene therapy Kresladi (libmeldagene autotelcel) has recently received FDA approval for the treatment of infantile Pompe disease (IOPD) . This is the world’s first one-time gene therapy for this disease, delivering a functional GAA gene to repair the defect at its source, overcoming the limitation of traditional enzyme replacement therapy requiring lifelong treatment, and bringing new hope for survival to severely affected children. I. FDA Approval Finally Granted! Kresladi Opens a New Chapter in Pompe Disease Treatment Let’s look at the key news first: Rocket Pharma’s Kresladi has received FDA approval, becoming the first approved one-time gene therapy for infantile Pompe disease . This drug uses an adeno-associated virus (AAV) vector to target and deliver the drug to the patient’s liver, where it continuously expresses the functional GAA enzyme. I’ve been following the clinical progress of this drug for over two years, ...
- Source: drugdu
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- March 30, 2026
The National Medical Products Administration has approved the marketing of Demozia maca injection

Recently, the National Medical Products Administration (NMPA) approved the marketing of Demozia macaase injection (trade name: Easily) submitted by GlaxoSmithKline Trading Services Limited. This product is indicated for maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older. The approval of this product provides a new treatment option for these patients. Source: Official WeChat account of the National Medical Products Administration https://mp.weixin.qq.com/s/_3PsNe601R7lhzvh1cSn2w
- Source: drugdu
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- March 30, 2026
Recombinant type A botulinum toxin for injection successfully approved for marketing

On the evening of March 27, Huadong Medicine announced that its exclusively distributed product, recombinant botulinum toxin type A for injection (trade name: Retoxin®), has been approved for marketing by the National Medical Products Administration for the temporary improvement of moderate to severe frown lines caused by the activity of the corrugator supercilii and/or depressor supercilii muscles in adults aged 65 and under. The announcement shows that Retoxin® was independently developed by Chongqing Yuyan Pharmaceutical and owns global intellectual property rights. Huadong Medicine owns the exclusive commercialization rights of this product in the field of medical aesthetic indications in mainland China, Hong Kong and Macau, as well as related priority acquisition rights and priority negotiation rights. In addition, the company holds 4.2787% of the equity of Chongqing Yuyan Pharmaceutical Co., Ltd. through its wholly-owned subsidiary Xinkeli Aesthetics (Hangzhou) Medical Technology Co., Ltd. According to Frost & Sullivan data, the Chinese ...
- Source: drugdu
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- March 30, 2026
providing new options for patients with psoriasis and hidradenitis suppurativa.

On March 27 , 2026 , Zhejiang Bioray Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as “Bioray Bio-Pharmaceutical”) and UCB, a global biopharmaceutical company, jointly announced that their biologic * (trade name: Bejule® ) , was approved by the National Medical Products Administration ( NMPA ) of China on the same day for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy , and for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne paradoxica) who have not responded well to conventional systemic therapy . This approval marks the official expansion of this first-line IL-17A/F dual-target biologic agent , the world’s first and currently the only one approved in China, from the field of rheumatology and immunology to the field of dermatology, bringing new treatment options to millions of patients in China suffering from these two chronic, relapsing, ...
- Source: drugdu
- 76
- March 30, 2026

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