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The first new drug for chronic sinusitis with nasal polyps in China was approved

On December 23, Conoya announced that its independently developed Class 1 new drug Kangyueda® (Sepkibaimab Injection) was approved for marketing by the National Medical Products Administration for the treatment of chronic sinusitis with nasal polyps (CRSwNP). Previously, this indication was included in the priority review. The prevalence of chronic sinusitis in my country is 8%, of which about one-third are patients with chronic sinusitis with nasal polyps. The pathogenesis of chronic sinusitis with nasal polyps is complex, and the clinical symptoms such as nasal congestion, hyposmia and runny nose caused by it seriously affect the quality of life of patients. Clinically, the treatment of this disease faces difficulties such as refractory and recurrent, and innovative treatment methods are urgently needed. Kangyueda® (sipkizumab) is a highly effective, humanized monoclonal antibody targeting the interleukin-4 receptor α subunit (IL-4Rα). It is the first IL-4Rα antibody drug approved for marketing in China and the ...
- Source: drugdu
- 251
- December 30, 2024
Tirzepatide’s new indication is approved by the FDA, becoming the first drug to treat “snoring”

Today, Eli Lilly and Company announced that the U.S. FDA has approved its blockbuster therapy Zepbound (tirzepatide) to improve snoring in obese patients with moderate to severe obstructive sleep apnea (OSA). Zepbound can help these patients improve sleep disorders, but they need to be combined with a low-calorie diet and increased physical activity. Trial results show that after one year of Zepbound treatment, up to 50% of patients no longer have symptoms related to OSA. According to the press release, Zepbound is the first prescription drug approved for the treatment of obese patients with moderate to severe OSA. Frequent snoring may be a sign of OSA. This condition is caused by the complete or partial collapse of the patient’s upper airway during sleep, resulting in airway obstruction, which may cause apnea or weakened breathing, and may be accompanied by decreased blood oxygen saturation or waking up during sleep. OSA can ...
- Source: drugdu
- 79
- December 28, 2024
Another senior executive of Baiyunshan was taken away within half a year

On December 20, Baiyunshan (600332.SH) issued an announcement stating that it had received a written resignation report submitted by Huang Haiwen, the company’s deputy general manager, on the same day. “Due to personal reasons, Huang Haiwen resigned from the position of deputy general manager of the company and all positions in the company’s affiliated enterprises.” Baiyunshan said that after his resignation, Huang Haiwen no longer held all positions in the company and its affiliated enterprises. This is the third senior executive of Baiyunshan to announce his resignation from “all positions” this year, following the resignation of the company’s former chairman Li Chuyuan (later officially announced to be dismissed) in July this year and director Zhang Chunbo in August. Reporters confirmed from multiple independent information sources that Huang Haiwen has been taken away by relevant departments for investigation. It is worth noting that Huang Haiwen, 43 years old, has a resume ...
- Source: drugdu
- 71
- December 28, 2024
FDA approves first “off-the-shelf” mesenchymal cell therapy

The U.S. FDA recently announced that it has approved Ryoncil (remestemcel) developed by Mesoblast for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged 2 months and older. The FDA’s press release stated that this is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Ryoncil is a mesenchymal stromal cell produced by allogeneic bone marrow. It regulates T cell-mediated inflammatory responses by inhibiting T cell proliferation and downregulating the production of proinflammatory cytokines and interferons. The safety and efficacy of Ryoncil were verified in a multicenter, single-arm study in which 54 pediatric patients with SR-aGVHD after allo-HSCT participated. Study participants received intravenous infusions of Ryoncil twice a week for a total of four weeks. The main basis for efficacy is the remission rate and duration of remission 28 days after the start of treatment. Results showed that 16 participants (30%) achieved complete remission after 28 days of treatment ...
- Source: drugdu
- 70
- December 28, 2024
Longsha Capsules and Health Ingredients Expand Capsule Production Capacity in China and India

Longsha Capsules and Health Ingredients (CHI) has added new capsule production lines at its factories in Suzhou, China and Ravali, India, demonstrating its long-term strategic commitment to this business segment and the Asia Pacific region. This expansion aims to balance CHI’s global layout, meet regional demand, and promote technological upgrades. Basel, Switzerland, December 19, 2024- Lonza Group, as a manufacturing partner in the global pharmaceutical, biotechnology, and nutritional health markets, announced that its factories in Suzhou, China and Ravali, India will undergo capacity expansion. The expansion project includes the addition of a gelatin hollow capsule (HGC) production line to support the production of high-quality gelatin hard capsules. The types of capsules produced cover both conventional and customized capsules required by the pharmaceutical and nutritional health products industries. This capacity expansion marks another important progress in Longsha CHI’s hollow hard capsule strategy, aimed at enhancing long-term competitiveness and meeting high quality ...
- Source: drugdu
- 66
- December 28, 2024
744 million! Medical equipment dark horse completes Series C financing again

According to the Medicine Intelligence Data Investment Pattern Database, Precision Neuroscience (hereinafter referred to as Precision) recently announced the completion of a new round of $102 million (contract 740 million RMB) Series C financing, bringing its total capital to $155 million. Investors participating in this round of financing include General Equity Holdings, B Capital, Duquesne Family Office of Stanley F. Druckenmiller, and Steadview Capital. This round of financing will be used to expand Precision’s team, advance clinical research work, and refine future versions of its AI driven brain implants. These implants are designed to enable severely paralyzed users to operate digital devices such as computers and smartphones solely through thinking. In addition, according to the Medicine Intelligence Data Investment Pattern Database, Precision also completed a Series C financing on November 6th this year, with a financing scale of 93 million US dollars (contract 679 million RMB). Advanced Brain Computer Interface ...
- Source: drugdu
- 269
- December 28, 2024
Bi Jingquan won the DIA Lifetime Achievement Award, and he opened the chapter of China’s innovative drugs

On December 19, in Washington, the United States, the International Drug Information Association (DIA) awarded Bi Jingquan the DIA Lifetime Achievement Award to thank him for his long-term outstanding leadership and extraordinary courage in promoting drug innovation and international cooperation. The chairman of the China Center for International Economic Exchanges (CCIEE) and former director of the China Food and Drug Administration was once evaluated by the industry as: the best director of the Food and Drug Administration in many years, and is also regarded by many as one of the key figures in promoting the development of China’s innovative drug industry. DIA, which awarded Bi Jingquan this time, is a global, interdisciplinary international academic platform with a high reputation in the field of global pharmaceutical research and development. In 2017, when the Chinese drug regulatory authorities sought to join the International Council for Harmonization of Technical Requirements for Pharmaceuticals for ...
- Source: drugdu
- 68
- December 27, 2024
【EXPERT Q&A】What information should be prepared for medical device export?

Drugdu.com expert’s response: Exporting medical devices requires a series of documents to ensure the legitimacy and safety of the products, as well as compliance with the relevant regulations and requirements of the importing country. Below is a detailed list of required documents: Ⅰ. Corporate Qualification Documents Business License: Certifies that the exporting enterprise has legal operating qualifications. Medical Device Operation License: If the enterprise engages in medical device operations, it must provide a Medical Device Operation License issued by the National Medical Products Administration. However, please note that for certain categories of medical devices, if their safety and effectiveness are not affected by the distribution process, they may be exempt from operation registration. Medical Device Production License: If the enterprise produces medical devices itself, it must provide this license to prove its qualification to produce medical devices. Identification Documents of the Legal Representative or Business Responsible Person: Provide copies of ...
- Source: drugdu
- 86
- December 27, 2024
The first cell impermeable membrane covered stent has been approved by the FDA for market launch

Recently, Merit Medical announced that its non permeable membrane covered stent, Wrapsody, has been approved by the FDA for sale. This is the first product approved by the FDA for the treatment of vascular stenosis or thrombosis in hemodialysis patients. It is reported that Merit Medical will start commercialization in the United States next year.The first heavyweight product has been launched Founded in 1987, Merit Medical is a leading medical device manufacturing enterprise that produces instruments used in cardiac and radiological interventional surgeries. The product line of Merit Medical Company includes interventional filling devices and their accessories, diagnostic and therapeutic catheters and guide wires, disposable pressure monitoring equipment, contrast agent management systems, non vascular stents, thrombolytic catheters, syringes and needles, etc. The company is committed to meeting the needs of global cardiology and radiology experts through product development and high-quality production. Hemodialysis is currently the most widely used blood purification ...
- Source: drugdu
- 72
- December 27, 2024
Jiangsu ProteLight’s antimicrobial peptide product Peceleganan has applied for listing, and CTTQ Pharma has obtained exclusive cooperation rights in China

On December 24, the official website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration announced that the marketing application of Pratt&Lyle’s Class 1 new drug Peceleganan Spray was accepted. In January 2023, CTTQ Pharma signed an exclusive commercial cooperation agreement with Pulei Pharmaceutical regarding the antimicrobial peptide product Peceleganan for the treatment of secondary wound infections in China. Peceleganan (PL-5) spray is a new polypeptide broad-spectrum anti infective drug, which belongs to non antibiotic anti infective drugs and has a unique bactericidal mechanism. According to the pipeline information on the official website of ProteLight Pharma, the fastest indication for the research process of this product is secondary wound infection. Secondary wound infection refers to open wound infection caused by various bacteria, including diabetes foot, bedsore, burn, etc. With the use of antibiotics, the proportion of drug-resistant bacteria is increasing, leading to the serious problem of ...
- Source: drugdu
- 61
- December 27, 2024

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