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 ...
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 ...
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 ...
Organiser:China Association for Medical Devices Industry Time:March 30 – April 1, 2026 Address:Intersection of Yingbin Avenue and Fanghua Road, Baiyun District, Guangzhou Exhibition hall:Guangzhou Airport Expo Center Product range: In Vitro Diagnostic Equipment Category: Biochemical analyzers, bacterial analyzers, urine analyzers, microbiological analyzers, electrolyte analyzers, hematology analyzers, blood analyzers, hemodialysis machines, enzyme-linked immunosorbent assay (ELISA) readers, chromatographs, PCR instruments, etc. In Vitro Diagnostic Reagent Category: In vitro diagnostic reagents, rapid diagnostic reagents, electrolyte reagents, hematology reagents, blood coagulation reagents, blood typing reagent kits, lipid reagents, biochemical reagents, chemiluminescent reagents, dry chemistry test strips, reagents for chlamydia detection, protein detection reagents, infectious disease detection reagents, tumor marker reagents, human gene detection reagents, immunohistochemistry and human tissue cell reagents, biochips, vitamin determination reagents, cellular and tissue chemical staining agents, self-diagnostic reagents, microbiological testing reagents, and other diagnostic reagents. Blood Collection and Transfusion Category: Blood collection and supply instruments and equipment, consumables, blood ...
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, ...
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
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 ...
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, ...
Recently, GE Healthcare announced that its photon-counting CT system, Photonova Spectra, has received 510(k) marketing clearance from the U.S. Food and Drug Administration. It is understood that this product features wide-area coverage and ultra-high-resolution spatial and spectral imaging capabilities, enabling rapid acquisition and precise display of subtle tissue differences, small lesions, and vascular structures. Moreover, equipped with its self-developed deep silicon detector technology, it builds a flexible photon-counting CT platform that can meet diverse clinical needs through various configurations. Its deep silicon technology offers 8-energy-level spectral resolution, supporting advanced material separation and characterization capabilities, allowing Photonova Spectra to accurately distinguish between different substances such as iodine, calcium, and fat. The wide-area detector coverage combined with a fast rotation speed of 0.23 seconds ensures high-speed acquisition and motion-artifact-free imaging. Furthermore, Photonova Spectra can automatically and simultaneously acquire 8-energy-level spectral data and ultra-high-resolution spatial data without requiring special settings or scanning protocols, ...
Recently, according to foreign media reports, Endogenex completed a $50 million (approximately 350 million yuan) Series C extension financing. This funding will be used to complete the development of its type 2 diabetes electrical pulse therapy and submit the technology to the U.S. Food and Drug Administration (FDA) for approval. Endogenex was founded in 2017 and focuses on the diabetes field. Its promising product—the ReCET system—targets the upper small intestine, specifically the duodenal region, aiming to reset inflammation and dysfunctional tissues associated with type 2 diabetes and improve the intestine’s ability to regulate blood sugar, appetite, and digestion. According to Endogenex, the ReCET system can deliver pulsed electric fields to the inner mucosal layer of the organ through an endoscopic electrode array, thereby clearing dysfunctional cells and stimulating tissue regeneration while avoiding potential thermal damage. This technology has previously received FDA breakthrough device designation. It is reported that shortly before ...
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