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Youcare Pharmaceutical’s subsidiary has received approval for its clinical trial from the FDA

News Report: On November 28th, Youcare Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Youcare Pharmaceutical”) released an announcement regarding the voluntary disclosure of its subsidiary YKYY018 nebulizer inhalation agent obtaining FDA approval for clinical trials. The announcement indicates that the wholly-owned subsidiary of Youcare Pharmaceutical, Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Youcare Kechuang”), recently received a notification from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) regarding the approval for the clinical trial of YKYY018 nebulized inhalation agent for the prevention and treatment of respiratory syncytial virus (RSV) infection (Study May Proceed Letter, IND number: 178457). The announcement indicates that respiratory syncytial virus (RSV) is a ubiquitous and contagious enveloped RNA virus that can cause respiratory diseases, particularly affecting susceptible groups such as children, the elderly, and individuals with compromised immune systems. As of now, there are no approved RSV infection ...
- Source: drugdu
- 60
- December 1, 2025
Vaccine makers actively expand overseas presence

November 27 – Yunnan Walvax Biotech Co., Ltd. announced that its 13-valent pneumococcal polysaccharide conjugate vaccine has recently obtained the “Biological Product Marketing Authorization” issued by the Egyptian Drug Authority (EDA), signifying the vaccine’s official approval for marketing in Egypt. Deng Zhidong, General Manager of Hainan Boao Medical Technology Co., Ltd., stated to Securities Daily that in recent years, several Chinese vaccine enterprises have leveraged their advantages of “high quality, cost-effectiveness, and flexibility” to effectively seize overseas market opportunities. Through diverse approaches such as exporting finished vaccines and providing localized production support, they are ensuring vaccine supply security in low-income countries and regions lacking independent production or procurement capabilities. According to the reporter’s research, recently multiple listed vaccine companies have announced new progress in their overseas market expansion, indicating an acceleration of their globalization strategies. On November 24, Beijing Sinovac Holdings (Group) Co., Ltd. signed two Product Development Partnership (PDP) ...
- Source: drugdu
- 58
- December 1, 2025
Surging Flu Data Drives Spike in Drug Demand, With Multiple Companies Including Nuotai Bio and Kangyuan Pharma Accelerating Market Entry

Influenza activity in China has recently entered a phase of rapid growth. The latest data from the Chinese National Influenza Center indicates that during November 10-16, 2025, the proportion of influenza-like illness cases reported by sentinel hospitals in southern provinces reached 6.7% of all outpatient and emergency visits. This represents an increase from the 5.5% recorded the previous week and also surpasses levels observed during the corresponding periods from 2022 to 2024. More recent reports show that the ILI proportion in northern sentinel hospitals has reached as high as 12%, two to three times higher than levels seen during the same periods from 2020 to 2023. Since November, the National Disease Control and Prevention Administration has issued three consecutive “Influenza Orange Alerts,” predicting the peak of this wave will occur between mid-to-late December this year and early January next year. The high incidence relates to this year’s circulating strains. Laboratory ...
- Source: drugdu
- 100
- December 1, 2025
Novartis’ innovative gene therapy receives FDA approval

On November 25, Novartis announced that its gene therapy Itvisma received FDA approval for the treatment of patients aged two years and older diagnosed with spinal muscular atrophy (SMA) and with a surviving motor neuron 1 (SMN1) gene mutation. Notably, this new therapy uses the same active ingredient as Novartis’ earlier Zolgensma therapy, which is primarily designed for SMA patients under two years of age. However, the availability of Itvisma expands the age range of eligible patients and provides them with new treatment options. The wholesale price of Itvisma is $2.59 million, while Zolgensma is $2.1 million. For SMA patients and their families, the successful approval of Itvisma is a major boon. As the only gene replacement therapy currently available for patients aged two years and older, it marks a new milestone in the treatment of this disease. SMA is a rare, inherited neuromuscular disease primarily caused by mutations or ...
- Source: drugdu
- 53
- December 1, 2025
Baili Tianheng receives $250 million in milestone payments

Baili Tianheng announced that SystImmune, Inc. (hereinafter referred to as “SystImmune”) recently received a milestone payment of US$250 million from Bristol-Myers Squibb (hereinafter referred to as “BMS”). The actual amount received will be subject to deduction of bank fees. Baili Tianheng is a comprehensive biopharmaceutical company that focuses on the forefront of global biopharmaceutical fields, is committed to solving unmet clinical needs, has world-leading innovative R&D capabilities, global clinical development and large-scale production and supply capabilities in the field of tumor macromolecular therapy (ADC/GNC/ARC), and will achieve global commercialization capabilities by 2029. Iza-bren (BL-B01D1) is a world-first, novel, and only EGFR×HER3 bispecific antibody ADC independently developed by SystImmune, possessing significant global clinical value and market potential. On December 11, 2023, SystImmune and BMS entered into an exclusive licensing and collaboration agreement (hereinafter referred to as the “Collaboration Agreement”) for the iza-bren (BL-B01D1, EGFR×HER3 bispecific antibody ADC) project. Under the collaboration ...
- Source: drugdu
- 66
- December 1, 2025
【EXPERT Q&A】What is the development trend of the veterinary diagnostic reagent industry? Market Size Continues to Grow

Drugdu.com expert’s response: The market size of China’s veterinary diagnostic reagent industry has expanded from 2.2 billion yuan in 2018 to 4.84 billion yuan in 2024, with a compound annual growth rate of 14.04%. It is expected to maintain a growth trend in the coming years. With the rapid development of the breeding industry, the demand for veterinary diagnostic reagents has been on the rise. Meanwhile, the emergence of the pet market has also brought new growth momentum to the industry. For instance, in 2024, there were 71.53 million pet cats and 52.58 million pet dogs in China, and the consumption scale of urban pets (cats and dogs) reached 300.2 billion yuan. The increasing demand for pet medical care has driven the development of the diagnostic reagent market. Continuous Technological Upgrades Detection Technology Iteration: Detection technology has been continuously advancing. For example, CRISPR gene-editing technology has reduced the detection limit ...
- Source: drugdu
- 87
- December 1, 2025
Hematological and biochemical indicators show growing value in breast cancer management

Breast cancer remains a predominant global health challenge for women, with late-stage diagnosis being a key contributor to its high mortality. This is particularly pronounced in low-resource settings where access to advanced, costly diagnostic tools is limited. There is a pressing need for affordable, non-invasive, and accessible diagnostic strategies. This review underscores the significant potential of hematological and biochemical serum markers as pivotal tools to bridge this diagnostic gap, offering insights into diagnosis, prognosis, and therapeutic monitoring for breast cancer. Hematological markers associated with breast cancer Hematological markers, derived from routine and inexpensive tests like the complete blood count (CBC), provide a window into the body’s physiological and pathological state, including systemic inflammation and immune response, which are hallmarks of cancer. Formed elements: Studies consistently show significant alterations in the cellular components of blood in breast cancer patients. These include decreases in hemoglobin (Hb) and red blood cell (RBC) counts ...
- Source: drugdu
- 75
- November 28, 2025
Aidoc Submits Breakthrough-Designated Multi-Triage Device for FDA Approval

Aidoc announced its completion of a pivotal study for its multi-triage device, powered by the CARE Foundation Model, designed to detect and prioritize double-digit abdominal conditions within a single solution.1 Following completion of this study, Aidoc submitted its CARE-powered breakthrough-designated device for FDA approval after the device displayed high levels of accuracy in a wide range of abdominal findings.1 “Broad foundation models are the path to expanding clinical AI across care delivery, but only if we raise the safety and quality bar beyond anything the field has seen,” said Elad Walach, CEO and co-founder of Aidoc. “Accuracy that works for one finding won’t hold for many. CARE delivers precision that limits false positives and elevates only what matters, avoiding the noise that has hindered physician adoption. Built for broad, real-world practice, this submission positions Aidoc for a historic first in presumably the most comprehensive CAD.” What is Aidoc’s CARE-powered multi-triage ...
- Source: drugdu
- 81
- November 28, 2025
Johnson & Johnson’s $3.05 billion acquisition of Halda

On November 17, Reuters reported that Johnson & Johnson announced it will acquire privately held oncology therapy research company Halda Therapeutics for $3.05 billion in cash . This acquisition aims to further expand Johnson & Johnson’s business footprint in the treatment of solid tumors and prostate cancer. Halda Therapeutics ‘ core drug candidate, HLD-0915, is currently in early to mid-stage development and is primarily intended for the treatment of prostate cancer. In addition to its core pipeline, the company has several early-stage experimental therapies for breast cancer, lung cancer, and other types of cancer, creating a highly complementary pipeline with Johnson & Johnson’s oncology business. It is worth noting that this is Johnson & Johnson ‘s second major acquisition this year. In January of this year, Johnson & Johnson acquired Intra-Cellular Therapies , a neuropharmaceutical research and development company, for $14.6 billion , continuing to deepen its presence in key ...
- Source: drugdu
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- November 28, 2025
The clinical trials of the new drug for Alzheimer’s disease are progressing smoothly

China Securities News (Reporter Deng Zhen) On November 28th, the Shanghai Securities News learned from Wanbangde that the company has been deeply engaged in the research and development of new drugs for Alzheimer’s disease (AD) for many years, always committed to developing new therapeutic drugs for global AD patients. Currently, the II/III phase key registration clinical trial of the company’s Selonyma Hydrochloride Controlled-release Tablets (FN12) is progressing smoothly. This clinical study is the largest Alzheimer’s disease registration study known in China. The company actively collaborates closely with CRO companies (contract research organizations for pharmaceutical development) to strive to obtain more effective data as soon as possible to verify the efficacy and safety of the drug. Existing data shows that Selonyma Hydrochloride Controlled-release Tablets have good safety. Selonyma, at an appropriate dose, can significantly improve the cognitive function of patients. At the same time, preclinical research shows that Selonyma not only ...
- Source: drugdu
- 68
- November 28, 2025

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