media – Page 35 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

BeiGene PD-1 issues first prescription in the United States, opens new chapter with its own international solid tumor commercialization team

In late October, BeiGene’s self-developed PD-1 inhibitor, Trastuzumab (English trade name: TEVIMBRA), was launched ®， Chinese product name: Baize An ®） The first prescription was issued in the United States, officially entering the American market and bringing new treatment options to local patients. This milestone also marks the beginning of a new chapter for BeiGene’s own commercialization team for solid tumors in the United States.Teralizumab was approved by the US Food and Drug Administration (FDA) in March 2024 for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). In October 2024, BeiGene announced the commercial launch of Trastuzumab in the United States, benefiting this patient population at a price 10% lower than other PD-1 therapies approved for this indication. The first prescription of Trastuzumab in the United States has become another important milestone in the company’s ...
- Source: drugdu
- 80
- October 29, 2024
Sinocell’s “RSV vaccine 1.2 category new drug” approved for clinical trials

According to the official website of CDE, SCTV02 injection, a Class 1.2 new drug for preventive biological use developed by Sinocell Engineering Co., Ltd. (hereinafter referred to as “Sinocell”), has obtained implicit approval for clinical trials. Its indication is to prevent diseases caused by respiratory syncytial virus (RSV) infection. Respiratory syncytial virus (RSV) is an infectious virus belonging to the genus Pneumovirus of the family Paramyxoviridae. It mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. According to statistics, almost all children have been infected with respiratory syncytial virus before the age of 2. Due to the large population base in China, the number of children with lower respiratory tract infections caused by RSV infection ranks relatively high in the world. RSV has always been called the ...
- Source: drugdu
- 117
- October 29, 2024
The first day of the national negotiations | Antiviral, anesthetic, antihypertensive drugs, etc. are being discussed! Hengrui, Hisense, Merck…appeared

On October 27, the 2024 National Medical Insurance Negotiations officially began at the National People’s Congress Conference Center in Beijing. The entrance to the venue was crowded. Some companies said that “the talks will not start until tomorrow, but we came in advance to check out the atmosphere.” This year, a total of 162 generic drugs will participate in the negotiations/bidding. The negotiations will be conducted by 25 negotiation experts from medical insurance departments selected from all over the country and divided into 5 groups. The negotiations will last until October 30, and the final results are expected to be announced in November. It is reported that the varieties of negotiations on the first day involve antiviral, anesthetic analgesic, antihypertensive and other fields. Hengrui, Merck, Kangyuan, Zhengda Tianqing, Renfu, Hisense, Xinlitai, Daiichi Sankyo, Baxter and other companies have entered the venue. Companies on the scene revealed that their Chinese medicine ...
- Source: drugdu
- 92
- October 29, 2024
Medtronic and Philips reach major cooperation

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families and society, and further expand and strengthen their partnership with the World Stroke Organization. It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment and postoperative monitoring. Philips and Medtronic reach cooperation It is reported that in this cooperation, Medtronic and Philips will work together to advocate for raising awareness of the potential health and ...
- Source: drugdu
- 56
- October 29, 2024
Six major centers of the National Medical Products Administration “gathered”, and the review and approval of medical devices were fully upgraded

On October 23, with the establishment of the National Medical Products Administration Information Center in Beijing Medical Innovation Park BioPark, the six major centers of the National Medical Products Administration have been “assembled”. The six centers are the Drug Review Center of the National Medical Products Administration’s directly affiliated units, the Food and Drug Review and Inspection Center, the Drug Evaluation Center (National Drug Adverse Reaction Monitoring Center), the Medical Device Technical Review Center, the Administrative Affairs Acceptance Service and Complaint Reporting Center, and the Information Center (China Food and Drug Regulatory Data Center). Beijing Yizhuang gathers regulatory resources to provide strong guarantees for the high-quality development of biotechnology and the big health industry in terms of enterprise industry administrative approval, qualification certification, etc. In the National Bureau’s administrative affairs acceptance service hall, 10 windows are neatly arranged to handle the acceptance, consultation, charging, and certification of administrative licensing matters ...
- Source: drugdu
- 60
- October 29, 2024
【EXPERT Q&A】Do I need a registered clinical trial for 3D endoscopy?

Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
- Source: drugdu
- 105
- October 28, 2024
Are stem cells the “terminator” of diabetes? Chinese scientists used stem cell regeneration therapy to cure type 1 diabetes for the first time

Cell, an international authoritative scientific journal, recently published a pioneering achievement from multiple research teams in China – the first time to use stem cell regeneration therapy to functionally cure type 1 diabetes. The research team used chemical reprogramming technology to induce pluripotent stem cells to prepare islet cells, and transplanted them to a type 1 diabetes patient, achieving clinical functional cure effect. So, how is it successful to induce stem cells to prepare pancreatic islet cells? Is functional cure truly a cure? Will stem cell technology be the key to conquer diabetes in the future? What is the difference between functional cure and cure Diabetes is a thorny disease, and its biggest harm to patients is that there are many clinical complications, which may lead to cardiovascular disease, nervous system damage, kidney disease, eye disease, foot disease, and so on. Diabetes ranks ninth among the world’s ten leading ...
- Source: drugdu
- 114
- October 28, 2024
AI+macrocyclic drug development | Circle Pharma completes $90 million Series D financing

On September 3, 2024, Circle Pharma, a biopharmaceutical company dedicated to discovering and developing cell permeable macrocycles as a clinical stage of a new therapy, announced the successful completion of $90 million in Series D funding, including the conversion of a convertible note.This round of financing is led by The Column Group, with new and old investors including Nextech Invest and Euclidean Capital participating. The funds raised from the financing will be used for the clinical development of Circle Pharma’s first and only similar cyclin A/B RxL inhibitor CID-078, and to support the development of the discovery project portfolio established by the company using its MXMO macrocycle platform. David Earp, CEO and Juris Doctor of Circle Pharma, said, “We are very grateful for the continued support of such a strong investor as we advance our pioneering work on macrocyclic therapy. This financing not only allows us to advance the clinical ...
- Source: drugdu
- 95
- October 28, 2024
Lixin Pharmaceuticals Completes RMB 300 Million C1 Round of Financing

Recently, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Lixin Pharmaceutical”) announced that it has successfully completed a C1 round of financing of RMB 300 million. This round of financing was led by China Biopharmaceutical, a well-known domestic industry party, and co-invested by Pudong Venture Capital and Zhang Jianghaoheng. Old shareholders Qiming Venture Partners and Shanghai Biomedicine Fund followed suit. Zhong Lun served as the legal advisor for this round of financing. Lixin Pharmaceuticals also mentioned that it has recently launched the C2 round of financing. The funds raised will be mainly used to accelerate the clinical progress of clinical pipelines, especially LM-302 and LM-108, and support the independently developed antibody discovery platform, next-generation ADC technology platform, and bispecific antibody technology platform, and continue to produce innovative pipelines with international competitiveness. About Lixin Pharmaceuticals Lixin Pharmaceuticals is a biopharmaceutical company based in China and facing the world. It ...
- Source: drugdu
- 94
- October 28, 2024
Hengrui Medicine Reports Revenue and Net Profit Growth in Q3

On the evening of October 24, Hengrui Medicine announced its Q3 performance report for 2024, showcasing steady growth in performance. For the first three quarters of 2024, Hengrui reported an operating revenue of 20.189 billion yuan, marking an increase of 18.67% year-on-year. The net profit attributable to shareholders reached 4.620 billion yuan, an increase of 32.98%, while the net profit after deducting non-recurring gains and losses was 4.616 billion yuan, reflecting a 37.38% increase, demonstrating robust development momentum. According to the report, Hengrui’s R&D expenditures reached 4.549 billion yuan in the first three quarters of 2024, marking a significant increase of 22% year-on-year. This ongoing high-intensity investment in R&D is providing strong momentum for the transformation of the company’s innovative achievements. As a result of these sustained investments, Hengrui is seeing a continual emergence of innovative outcomes. During the reporting period, Hengrui launched its self-developed Class 1 new drug, Fuhuanqi ...
- Source: drugdu
- 133
- October 28, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.