media – Page 41 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Adhere to Innovation and High Quality Promotion of New Drug Research and Development

Recently, a reporter from China Securities Journal visited the Xinda Biotech Global R&D Center (Medical) in person. The research and development center is located in the New Hongqiao International Medical Center in the Hongqiao Business District of Shanghai, and was officially opened in August this year. Relying on the national strategy of integrating the Yangtze River Delta, Xinda Biotechnology has formed a three in one coordinated development situation of Suzhou headquarters, Shanghai R&D center, and Hangzhou industrialization base. Xinda Biotech has been deeply involved in the field of innovative drugs for more than ten years, including the first PD-1 inhibitor to be included in the national medical insurance catalog (Daboshu), the world’s first GCG/GLP-1 dual receptor agonist, Masidopeptide, and the first domestically developed PCSK9 inhibitor, Trastuzumab Injection (Xinbile). Looking ahead to the future, Qian Lei, Senior Vice President of Clinical at Xinda Biotechnology, stated in an interview with China Securities ...
- Source: drugdu
- 171
- December 21, 2024
The new technology route of two major single product vaccines of Aimei vaccine has obtained clinical approval

On December 19th, Aimei Vaccine announced that its two major single product vaccine new technology routes, suspension cultured MDCK cell influenza vaccine and second-generation high-efficiency adsorption tetanus vaccine, have both obtained the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration. These are two significant developments made by the Emmy vaccine during the intensive declaration period, which are expected to bring new growth points. According to the announcement, currently all influenza vaccines listed in China are produced using chicken embryo technology, and no cell-based influenza vaccine has been approved for market. The MDCK cell influenza vaccine approved for clinical use has significantly improved product quality and safety compared to traditional chicken embryo influenza split vaccines. The MDCK cells developed by Aimei have characteristics such as easy cultivation, fast proliferation, and susceptibility to influenza virus. By culturing influenza virus on a large scale in MDCK cells, higher yields, more ...
- Source: drugdu
- 174
- December 21, 2024
The stone medicine AI has exploded

Shiyao Group has once again achieved a heavyweight business development. Recently, Shiyao announced that it has reached a BD agreement with BeiGene regarding the group’s new methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH2039, granting BeiGene the global development and commercialization rights for the pipeline. And the amount of BD this time is also very astonishing: Shiyao Group will receive a total advance payment of $150 million, and has the right to receive up to $135 million in potential development milestone payments and up to $1.55 billion in potential sales milestone payments, as well as tiered sales commissions calculated based on the annual net sales of the product. It is worth mentioning that the compound was selected by Shiyao through AI technology. Previously, Shiyao also provided AstraZeneca with a high priced BD through a preclinical pipeline screened by AI technology. The stone medicine AI has exploded. 01 Why is it stone medicine? ...
- Source: drugdu
- 159
- December 20, 2024
Over 9.6 billion, three transactions per day!

What is the hottest segment of the pharmaceutical industry in 2024? TCE is definitely on the list. The frequent occurrence of heavyweight transactions, large-scale financing, mergers and acquisitions, NewCo, and other events fully demonstrates the extraordinary vitality and heat of this track. On December 16th, the hot TCE once again became a key betting track for the pharmaceutical industry. Within a day, Candid Therapeutics announced consecutive TCE partnerships with three companies: Nona Biotech, Anmai Biotech, and Ab Studio. It is known that the total amount of cooperation is as high as 1.32 billion US dollars (approximately 9.614 billion yuan). Candid has partnered with Nona Biotech, Anmai Biotech, and Ab Studio respectively, as shown on Candid’s official websiteOn December 16th local time, Candid announced that it has reached a research cooperation and authorization agreement with Novo Biologics, a subsidiary of Happyl Pharmaceuticals, for the development of the next generation T cell ...
- Source: drugdu
- 134
- December 20, 2024
Targeting Chinese patent medicines, the State Food and Drug Administration has taken another action

Recently, the State Food and Drug Administration issued the “Notice on Simplifying the Registration and Approval of Traditional Oral Chinese Patent Medicines Already Marketed in Hong Kong and Macao for Market Registration in the Mainland (Draft for Comments)” (hereinafter referred to as the “Draft for Comments”). The registration and approval of traditional oral Chinese patent medicines in Hong Kong and Macao in the Mainland is expected to be further simplified, and the technical review period for qualified varieties will be shortened from the conventional 200 working days to 80 working days. ▍Key points analysis The “Draft for Comments” clearly states that the relevant applicant companies and varieties must meet three conditions at the same time: traditional oral Chinese patent medicines held by local registered manufacturers in the Hong Kong and Macao Special Administrative Regions, approved for market listing by the Hong Kong and Macao Special Administrative Regions’ drug supervision and ...
- Source: drugdu
- 88
- December 20, 2024
Can 3 cents produce a piece of aspirin?

Recently, after the announcement of the proposed winning results of the 10th national centralized drug procurement, the centralized procurement price of 3 cents a piece of aspirin attracted national attention as a “low price”. The public’s concern is largely due to the concern about whether the clinical efficacy of the drug can be guaranteed at a low price. So, can 3 cents produce a piece of qualified aspirin? ▍3 cents can produce The answer is yes. “This price can be achieved through large-scale production. Since the raw materials of aspirin itself are relatively cheap and the excipients are not particularly expensive, if the equipment conditions are good and the output is large, its cost will also be reduced. It does not mean that when the price drops to a certain level, the product quality will be low and the company will cheat. This is a commercial behavior. The company takes ...
- Source: drugdu
- 124
- December 20, 2024
Kanghua Biotech’s Recombinant Norovirus Vaccine (Pichia pastoris) Approved for Clinical Trials

On December 17, Kanghua Biotech (300841) announced that its hexavalent recombinant Norovirus vaccine (Pichia pastoris) has received a clinical trial approval notification. The vaccine developed by the company has recently been issued a “Clinical Trial Approval Notification” by the National Medical Products Administration, granting permission to conduct clinical trials. This vaccine is intended to prevent Norovirus infections and the acute gastroenteritis they cause, with the theoretical ability to prevent over 90% of related infections. The receipt of the clinical trial approval notification will not have a significant impact on the company’s short-term financial status and operating performance. The company will actively promote clinical research for this product; if successful, it will enrich the company’s product portfolio, enhance its core competitiveness and market position, thereby increasing profitability. However, the vaccine development process is lengthy and technically challenging, posing certain research risks and uncertainties that investors should consider cautiously. In the first ...
- Source: drugdu
- 137
- December 20, 2024
Can small molecule drugs achieve a breakthrough?

Wet age-related macular degeneration (Wet AMD) is the main cause of visual dysfunction and blindness in the elderly. Currently, intravitreal injection of anti-VEGF drugs has become the first-line treatment for the disease, but current anti-VEGF drugs still have many shortcomings, such as frequent injections with multiple potential risks, insensitive reactions in some patients, and low patient compliance. Therefore, it is urgent to find new therapeutic drugs. With the deepening of the understanding of pathological mechanisms, the emergence of multi-target small molecule drugs has opened up a new path for the treatment of this disease. Compared with the traditional approach of only inhibiting VEGF, these small molecules are expected to provide new opportunities for improving efficacy, reducing treatment burden and delaying drug resistance by intervening in multiple links such as angiogenesis, inflammation and oxidative stress. AMD, The third leading cause of blindness worldwide Age-related macular degeneration (AMD) is an age-related, chronically ...
- Source: drugdu
- 170
- December 20, 2024
【EXPERT Q&A】What are the content requirements of the medical device Post-marketing Supervision Plan (PMS Plan) required by the EU CE?

Drugdu.com expert’s response: The Post-Market Surveillance (PMS) Plan for medical devices required by the EU CE is a comprehensive strategic document aimed at ensuring the continued safety, effectiveness, and compliance of medical devices after they have been released to the market. The core content of this plan revolves around the following aspects, aiming to establish a comprehensive and responsive surveillance system: Firstly, defining objectives and scope. The PMS Plan must clearly outline its objectives, which are to ensure the safety and effectiveness of medical devices during use while minimizing potential risks. It should encompass all key stakeholders, including manufacturers, distributors, users, and regulatory authorities, and be applicable to various types of medical devices, both for home use and professional purposes. Secondly, establishing a data collection and analysis mechanism. The plan requires the creation of an efficient data collection system to capture information from multiple sources, such as sales data, user ...
- Source: drugdu
- 129
- December 20, 2024
China Biopharmaceuticals and Sinopharm Holdings sign strategic cooperation agreement

On December 13th, China Biopharmaceutical and Sinopharm Group signed a deep strategic cooperation agreement in Chengdu. The two sides will fully integrate the resources of Sinopharm Group’s National University Pharmacy, SPS+professional pharmacy, and China Biopharmaceutical’s rich product resources, and carry out deep cooperation in the off hospital market to jointly build a nationwide retail network and improve the convenience of patients’ drug purchases. President Lian Wanyong and Vice President Wu Yijian of China National Pharmaceutical Group, CEO of China Biopharmaceutical and Chairman of CP Tianqing Xie Chengrun, Vice President of CP Tianqing Chen Hui, and others attended the signing ceremony. Liu Tianyao, General Manager of the Global Procurement and Supply Chain Service Center of China National Pharmaceutical Group, and Qi Tianze, Special Assistant to the Chairman of CP Tianqing, signed the agreement on behalf of both parties. The heads of various business units of China Biopharmaceutical and some subsidiaries of ...
- Source: drugdu
- 150
- December 19, 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.