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The approval of clinical trials of innovative drugs is expected to be accelerated! The National Medical Products Administration plans to implement a 30-working-day approval system

On June 16, the State Food and Drug Administration optimized the innovative drugsThe draft for comments on clinical trial review and approval was released. It mentioned that in order to further support the research and development of innovative drugs oriented to clinical value and improve the quality and efficiency of clinical research and development, the review and approval of innovative drug clinical trial applications that meet the requirements will be completed within 30 working days. The 30-day channel for the review and approval of drug clinical trial applications supports national key research and development varieties, encourages global early synchronous research and development and international multi-center clinical trials, and serves clinical urgent needs and the development of the national pharmaceutical industry. The draft for comments proposes that applications for inclusion in the 30-day channel for the review and approval of innovative drug clinical trials should be for traditional Chinese medicines., Chemicals, ...
- Source: drugdu
- 139
- June 19, 2025
Another “patent extension king” for Chinese medicines is born

Recently, Rongchang Bio announced that it had received the “Approval Decision on Compensation for Pharmaceutical Patent Term” issued by the State Intellectual Property Office, stating that its core product, Taitasip Injection, received 1,827 days of patent compensation, and the protection period was extended from June 15, 2027 to June 15, 2032. It is worth noting that this is another case in which the pharmaceutical industry has achieved “maximum compensation” since the implementation of the new “Patent Law of the People’s Republic of my country” (hereinafter referred to as the “Patent Law”) in 2021. Institutional breakthrough Since June 1, 2021, my country’s new Patent Law has come into effect, which adds a clause on compensation for the patent term of drugs. Article 42, paragraph 3 of the Patent Law stipulates: In order to compensate for the time taken for the approval of new drug marketing, the State Council Patent Administration Department ...
- Source: drugdu
- 162
- June 19, 2025
Eight-year Takeda veteran joins BeiGene

According to reports from multiple media outlets including 21st Century Business Herald and The Paper, Shan Guohong, global senior vice president of Takeda Pharmaceutical and president of Takeda China, will step down and may join BeiGene next. 8-year veteran In September 2017, Shan Guohong became the president of Takeda China, which marked the start of Takeda China’s business boom. In 2020, Takeda China launched the “Wu Ju Future” five-year development plan, proposing the goal of launching more than 15 innovative products in China by 2025, benefiting more than 10 million Chinese patients. Under his outstanding leadership, Takeda China has climbed from the 23rd place in the foreign-invested pharmaceutical market to the 9th largest foreign-invested pharmaceutical company, becoming Takeda’s third largest market in the world, second only to the United States and Japan, and more than half of its business comes from growth pipelines and newly launched products. What is even ...
- Source: drugdu
- 131
- June 19, 2025
MD&M

Organiser: Informa Time：October 21st – October 22nd, 2025 address：1301 2nd Avenue South, Minneapolis, MN 55403, USA Exhibition hall：Minneapolis Convention Center Product range: Medical Supplies: Anesthesia and pulmonary medications, home healthcare products, cardiovascular products, orthopedic surgical instruments, radiology and medical imaging equipment, emergency care products, surgical instruments, sports medicine and rehabilitation therapy products, in-vitro diagnostic equipment, and general hospital supplies and equipment Medical Materials & Components: New materials, 3D printing, robotics and automation, silicone, mobile power solutions, essential considerations for avoiding battery failures in medical devices, innovative medical devices, metal 3D printing, intelligent layering, and integrated product design and development services Medical Devices: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical equipment, dental service equipment and disposable medical products, disposable medical products for hospital and home use, hospital dental and medical data ...
- Source: drugdu
- 197
- June 19, 2025
New AHA Scientific Statement Reconsiders Moderate Alcohol Use in Relation to Cardiovascular Health

Several medical groups have concluded regular consumption of alcohol in any amount poses a health risk, but a new scientific statement from the American Heart Association (AHA) offered more qualified guidance. The premise that moderate alcohol use reduces cardiovascular risk has been widely accepted for decades. The authors of a 1993 editorial in The New England Journal of Medicine concluded “there now seems little doubt” that such a benefit exists. However, a review of the evidence in 2025 produced a more cautious summary. “Considering the level of evidence, it remains unknown whether drinking is part of a healthy lifestyle, and therefore, clinicians should reinforce healthy lifestyle behaviors such as regularly engaging in physical activity, avoiding tobacco use, and maintaining healthy body weight,” the AHA document stated. Complex Mix “Data from recent studies using new methodologies (eg, individual participant-level data meta-analysis and Mendelian randomization [MR]) have challenged the idea that ...
- Source: drugdu
- 171
- June 18, 2025
ADHD Stimulants Can Be Safely Prescribed Via Telehealth, Study Argues

By Dennis Thompson HealthDay ReporterMONDAY, June 16, 2025 (HealthDay News) — People with ADHD might be prescribed their meds remotely without increasing their risk of addiction, a new study says. Experts have worried that prescribing stimulants like Adderall through telehealth visits might increase substance abuse among people with attention-deficit/hyperactivity disorder (ADHD). But this study found no increased risk among ADHD patients prescribed their meds via telehealth versus those who got their scrips at an in-person visit, according to results published June 11 in the American Journal of Psychiatry. “Our study suggests that, generally, telehealth-based relationships – which make health care more accessible – can be safe and don’t increase the risk of substance use disorder,” lead researcher Dr. Vinod Rao, medical director of adult ambulatory psychiatry at Massachusetts General Hospital in Boston, said in a news release. For the study, researchers tracked nearly 8,000 patients treated for ADHD at Massachusetts ...
- Source: drugdu
- 191
- June 18, 2025
30 working day review channel will be opened

Innovative drug payment breaks through the ten-year road from “payment desert” to “trillion dollar blue ocean”. Pharmaceutical companies are at the moment of innovation: giants turn around, innovators seek gold On June 16th, the National Medical Products Administration released the “Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (Draft for Comments)” (hereinafter referred to as the “Draft for Comments”), which marks the beginning of a transformation that may reshape the development pattern of innovative drugs in China – the clinical trial review and approval cycle for core innovative drug varieties is expected to be compressed to 30 working days. Clinical trials are an important part of innovative drug development. The optimization of the clinical trial review and approval pilot for innovative drugs can significantly improve research and development efficiency, and is the key to China’s move towards becoming a global hub for innovative drug ...
- Source: drugdu
- 262
- June 18, 2025
Venture capital is the “navigator” of innovative drugs, not just a simple “money bag”

With the frequent occurrence of large-scale license out transactions, China’s innovative pharmaceutical industry is constantly proving its research and development capabilities in front of global capital and multinational pharmaceutical companies. The other side of the industry’s positive momentum is that primary market investment and financing transactions are still in a low period. Focusing on the field of innovative drugs, some companies have secured large global BD deals, while many others are still struggling on the path of financing. This means that China’s innovative pharmaceutical industry is entering a stage of differentiation – leading companies with clinical data, global vision, and financing capabilities are gradually breaking through, while most companies still face the dual test of survival and development. In June of this year, 21st Century Business Herald interviewed Xu Qian, Managing Partner and General Manager of Danlu Capital in Beijing, to discuss the role of venture capital in the ...
- Source: drugdu
- 246
- June 18, 2025
Boan Biopharma’s BA1302 receives FDA approval for clinical trials

On June 17, Boan Bio (06955) issued an announcement, announcing that its independently developed innovative antibody-drug conjugate BA1302 targeting CD228 has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials. 　　The drug is intended for the treatment of a variety of solid tumors and has been granted orphan drug designation by the FDA for squamous non-small cell lung cancer and pancreatic cancer. Currently, BA1302 is undergoing Phase 1 clinical trials in China, and its global progress is ahead of other similar research and development efforts. 　　BA1302 has shown excellent internalization activity and bystander effects in preclinical studies, and can effectively inhibit the growth of tumor models derived from various cancer patients, showing good therapeutic potential. In addition, compared with the marketed ADCs with MMAE as toxin, BA1302 has shown a longer half-life and better safety in crab-eating monkeys. The company will ...
- Source: drugdu
- 255
- June 18, 2025
First patients enrolled in Phase I clinical trial of Clover Biopharmaceuticals combination vaccine

On June 17, Clover Biopharmaceuticals (02197) issued an announcement announcing that its respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) ± parainfluenzaThe Phase I clinical trial of the PIV3 combined vaccine candidate product has completed the enrollment of the first batch of subjects. 　　The vaccine candidates involved in this trial include SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3), which are developed based on the company’s protein trimerization vaccine technology platform. 　　According to the announcement, the Phase I clinical trial results of Clover Biopharmaceuticals’ RSVPreF vaccine candidate product (SCB-1019) announced in October 2024 showed that the vaccine had potentially best-in-class immunogenicity and tolerability characteristics in 70 elderly subjects. 　　This clinical result provides support for the company’s subsequent joint development of hMPV and PIV3 vaccines. The current Phase I clinical trial of the combined vaccine candidate product will enroll up to 192 elderly subjects to evaluate its safety, reactogenicity and ...
- Source: drugdu
- 148
- June 18, 2025

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