Today (May 27), Merck announced that its Animal Health division’s live vaccine for infectious bronchitis (strain 4-91), Poultry Bibi® Spread ( hereinafter referred to as Spread® ) , has recently been approved by the Ministry of Agriculture and Rural Affairs of China for the prevention of infectious bronchitis caused by the 4-91 variant of the infectious bronchitis virus . acute, highly contagious respiratory disease caused by infectious bronchitis virus (IBV), a virus belonging to the genus Coronavirus in the family Coronaviridae . It has a short incubation period, spreads rapidly, and has a high morbidity rate, making it one of the major disease threats facing the global poultry industry. Based on the different tropisms of the virus to various organs and tissues of chickens, IB can be divided into respiratory, renal, reproductive, and intestinal types. Among them, chicks have the highest mortality rate after infection , while adult chickens mainly ...
Recently, Qianjin Pharmaceutical issued an announcement stating that its subsidiary, Qianjin Xiangjiang Pharmaceutical, has officially received approval from the National Medical Products Administration for the marketing of its generic drug ” Lactulose Oral Solution .” This drug will primarily be used for the treatment of chronic or habitual constipation, as well as the prevention and treatment of hepatic encephalopathy. Of particular note is the project’s return on investment . The announcement shows that Qianjin Xiangjiang Pharmaceutical’s cumulative R&D investment in lactulose oral solution is 2.9505 million yuan . According to data from Yaozhi, the total sales of lactulose oral solution in the domestic market reached 2.356 billion yuan in 2025 . This means that Qianjin Pharmaceutical has successfully entered a mature market with annual sales exceeding 2.3 billion yuan with a research and development cost of less than 3 million yuan. 01 A “long-standing” figure in the field of gastroenterology ...
Innovent Biologics (SSE: 688428; HKEX: 09969) today announced that orelabrutinib (product name: Enokai® ) has been approved for marketing by the Australian Therapeutic Goods Administration (TGA), providing better treatment options for patients with mantle cell lymphoma. Mantle cell lymphoma is a specific subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by its aggressive nature and difficulty in achieving a complete cure, with its incidence rate increasing year by year. At diagnosis, the disease often progresses to an advanced stage, presenting challenges such as limited treatment options and a poor overall prognosis. Orelabrutinib is a highly selective, novel BTK inhibitor independently developed by InnoCare Pharma. It can effectively avoid adverse reactions caused by off-target effects and significantly improve the safety and efficacy of treatment. Currently, orelabrutinib has been approved in Singapore for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) and relapsed/refractory mantle cell lymphoma (R/R MCL). In China, orelabrutinib has ...
[Shanghai, China, May 28, 2026] SciGene Pharmaceuticals today announced the official launch of its novel antibiotic, telavancin hydrochloride for injection, in China for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. The commercial launch of telavin hydrochloride for injection in China provides a new treatment option that combines a unique dual bactericidal mechanism with clinical convenience for the treatment of infections caused by multidrug-resistant Gram-positive bacteria, especially severe pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA). Long-lasting antibacterial activity to combat drug resistance challenges Infections caused by Staphylococcus aureus are highly dangerous. With the widespread use of antibiotics, drug-resistant strains such as MRSA are constantly emerging, exhibiting resistance to multiple antibiotics and sensitivity only to a few drugs such as vancomycin. Furthermore, even within the same class of antibiotics, different subspecies may exhibit differences in antibacterial activity. Tieravancin hydrochloride for injection is a ...
On May 27, AbbVie announced that Decnupaztm (Pivekimab sunirine-pvzy) has received FDA approval for the treatment of adult patients with blastic plasmacytoid dendritic cell tumors (BPDCN). Pivekimab sunirine-pvzy is the world’s first approved CD123 ADC . CD123 (IL-3Rα) is a protein overexpressed in BPDCN and is an ideal therapeutic target. This approval is supported by data from the Phase I/II CADENZA study. This study was a multicenter, open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antileukemic activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN. The results showed that newly diagnosed BPDCN patients treated with pivekimab sunirine-pvzy exhibited clinically significant and durable responses. In newly diagnosed BPDCN patients (n=33), the overall complete response rate was 69.7%, with a median duration of response (DOR) of 9.7 months, and 13 patients (39.4%) were able to receive stem cell transplantation after the study. In relapsed or refractory BPDCN ...
On May 27, the CDE (Center for Drug Evaluation) website showed that GlaxoSmithKline (GSK) has resubmitted its marketing application for its new chronic hepatitis B drug, Bepirovirsen injection. Bepirovirsen was first submitted for marketing approval in China on March 27 this year, with the indication being limited-course treatment of chronic hepatitis B virus infection in adults with chronic hepatitis B virus infection who are currently receiving nucleoside (nucleotide) analogue therapy, have HBsAg ≤3000 IU/mL, and do not have cirrhosis. On May 21, the application received a drug notification from the National Medical Products Administration (NMPA). Beprovirsen is an antisense oligonucleotide (ASO) therapy acquired by GSK from Ionis. It aims to inhibit the replication of hepatitis B virus DNA, thereby suppressing the level of hepatitis B surface antigen (HBsAg) in the blood and stimulating a sustained immune response. This drug is the first small nucleic acid drug in the field of ...
Drugdu.com expert’s response: Medical device export testing and certification requirements are not determined by “export” as a general concept. They mainly depend on the target market + product category + risk classification. The same product may face very different requirements when exported to the EU, the United States, the UK, or Southeast Asia. Generally, the requirements can be assessed from the following aspects: I. Basic General Requirements 1. ISO 13485 Quality Management System Certification ISO 13485 is one of the most common quality management system certifications for medical device companies. It is often recognized by overseas customers, registration authorities, and procurement channels. It is not a “market access certificate” for every country, but it is usually an important basic document for medical device export. ISO 13485 focuses on whether the company has established a quality management system that meets medical device regulatory requirements, including design and development, production control, risk ...
Organiser:MEDICA Time:November 16–19, 2026 Address:Ostfach 10 10 06, D-40001 Düsseldorf Stockumer Kirchstraße 61, D-40474 Düsseldorf, Germany Exhibition hall:Düsseldorf Exhibition Center Product range: Medical Equipment: Medical electronic instruments, clinical analysis instruments, dental equipment & materials, hemodialysis equipment, respiratory equipment, hospital ward / operating room / emergency room equipment, hospital office equipment, etc. Imaging & Diagnostics: Ultrasound systems, X-ray equipment, medical optical instruments Disposable Consumables: Disposable medical supplies, dressings & hygiene materials, surgical instruments, etc. Medical Aids: Healthcare aids, home care products, physiotherapy, orthopedic technology, etc. Medical Peripherals: ICT, medical services & publications, IT systems & IT solutions, etc. Laboratory Equipment Physiotherapy / Orthopedic Technology About MEDICA: MEDICA, the world’s largest and most authoritative trade fair for hospital and medical equipment, is held annually in Düsseldorf, Germany. With an irreplaceable scale and influence, it ranks first among global medical trade shows. The exhibition covers the entire spectrum from outpatient to ...
On May 26 (today), Eli Lilly announced agreements to acquire three vaccine companies — Curevo Inc., LimmaTech Biologics AG, and Vaccine Company, Inc. — officially entering the human vaccine arena. This acquisition is part of Eli Lilly’s strategy to continuously invest in differentiated technology platforms and tackle major health challenges. In its 150-year history, Lilly has made significant progress in diabetes, obesity, Alzheimer’s disease, autoimmune diseases, and cancer. Infectious diseases, as a major driver of global morbidity, still pose unresolved public health challenges in terms of acute illness and long-term health consequences from primary infections. Dr. Daniel M. Skovronsky, Eli Lilly’s Chief Scientific and Product Officer and President of Lilly Research Laboratories, stated that this acquisition reflects the company’s strategic direction of preventing disease at its source rather than merely treating its consequences. Existing research shows that common infections may trigger neurological diseases, cancer, infertility, and other conditions years later. ...
On May 25, 2026, Eternal Medicines officially announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the new drug application for eltromod (trade name: Vistip®) . This drug will be used to treat adult patients with moderate to severe active ulcerative colitis who have not responded well to or are intolerant of traditional treatments or biologics, bringing a new treatment option to patients in Korea. Ulcerative colitis, a chronic inflammatory bowel disease, has an incompletely understood etiology and is characterized by a high recurrence rate. Typical symptoms such as mucus and bloody stools, abdominal pain, and diarrhea severely impact patients’ quality of life. In recent years, the incidence of this disease has been steadily increasing in Asia, creating an urgent clinical need for safe, effective, and convenient treatment drugs. Visip® is a highly selective sphingosine-1-phosphate (S1P) receptor modulator taken orally once daily. Through optimized pharmacological design, ...
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