media – Page 170 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

The highest unit price is 176,000 yuan, dismantling the first cell storage stock

Cell storage has never been a new topic. In the promotion of cell storage, these precious biological resources, from stem cells to immune cells, can be stored in case of emergency through freezing, and play a key role in treating diseases, delaying aging and even regenerative medicine. Simply put, storing your own cells is an investment in future health, although this is expensive. “The most expensive unit price is 176,000 yuan, and it is stored for 20 years,” Shanghai Cell Therapy Group, which applied for an IPO on the Hong Kong stock market, revealed to us the tip of the iceberg of the cell storage business. Relying on the cell storage business, Shanghai Cell Therapy Group earns 600 million yuan a year and supports the company’s IPO. So, what is the clinical value of cell storage? What kind of business is this? The reason why it is called “the first ...
- Source: drugdu
- 189
- December 17, 2024
Xinghao Pharmaceutical’s Naloxone Hydrochloride Injection Expected to Win Bid in the Tenth National Centralized Procurement

On December 12, Xinghao Pharmaceutical announced that its subsidiary, Guangdong Xinghao Pharmaceutical Co., Ltd., participated in the bidding process organized by the Joint Procurement Office for the tenth batch of national centralized drug procurement. The company’s product, Naloxone Hydrochloride Injection, is expected to win the bid in this centralized procurement, with an intended bid price of 1.37 yuan per vial. It is reported that Naloxone Hydrochloride Injection is an opioid receptor antagonist used to counteract respiratory depression caused by opioid drugs in narcotic anesthesia and to promote patient awakening, as well as to rescue individuals from acute ethanol poisoning. Xinghao Pharmaceutical stated that if the company subsequently signs a procurement contract and implements it, this will further expand the sales of related products, increase market share, enhance the company’s brand influence, and have a positive impact on the company’s future operating performance. https://finance.eastmoney.com/a/202412133267927671.html
- Source: drugdu
- 182
- December 16, 2024
Huahai Pharmaceutical’s Subsidiary Adalimumab Injection Drug Registration Application Accepted

Financial Associated Press, December 13 – Huahai Pharmaceutical (600521) released a notice regarding the acceptance of its subsidiary’s application for drug marketing authorization. The company’s wholly-owned subsidiary, Zhejiang Huahai Biotechnology Co., Ltd., has recently received the “Acceptance Notice” issued by the National Medical Products Administration for the application for the domestic production registration of adalimumab injection. This medication is primarily used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, and other conditions, and is classified as a Class 3.3 therapeutic biological product. To date, the company has invested approximately 193 million yuan in research and development for this project. According to estimates from Frost & Sullivan, the sales revenue of adalimumab biosimilars in China is expected to grow from approximately 2.2 billion yuan in 2022 to approximately 4.851 billion yuan in 2023, with the market size projected to reach 11.5 billion yuan by 2030. This acceptance marks the entry of the ...
- Source: drugdu
- 272
- December 16, 2024
Jin Pharmaceutical’s Subsidiary Potassium Chloride Injection Obtains Consistency Evaluation for Generic Drugs

Jin Pharmaceutical (600488) announced that its subsidiary, Jin Pharma Peace (Tianjin) Pharmaceutical Co., Ltd., has recently received approval from the National Medical Products Administration (NMPA) for its potassium chloride injection, successfully passing the consistency evaluation for the quality and efficacy of generic drugs. This medication is classified as a category A product under the national medical insurance system and is primarily used to treat and prevent hypokalemia, making it suitable for patients who cannot take potassium supplements orally. As of now, Jin Pharma Peace has invested approximately 4.93 million yuan in research and development for the potassium chloride injection project. According to market data, the domestic sales revenue for potassium chloride injection was 612 million yuan in 2022 and 661 million yuan in 2023. With the successful completion of the consistency evaluation, the market competitiveness of this product is expected to improve, and medical institutions are likely to prioritize the ...
- Source: drugdu
- 333
- December 16, 2024
Roche clears a track with one click

MNC Roche took out a “machete”. In Roche’s 2024Q2 PPT presentation, there are 5 pipelines in the anti-infection pipeline echelon, 4 of which are Ruzotolimod (TLR7 agonist), Xalnesiran (small interfering RNA), PDL1 LNA and HBsAg monoclonal antibody, all of which are in Phase I and II clinical trials. When it comes to the presentation of 2024Q3, the situation has changed. Roche cut off the above 4 pipelines with the target indication of hepatitis B at one time. The company did not give a specific reason for the “clearance”. The most speculation in the market is that the clinical pipeline data is “unsatisfactory + Roche streamlines the pipeline to focus its energy and investment on core areas”. However, for Roche, the anti-infection sector has always been a relatively marginal module of the company. In the key drivers introduced by the company in 2024Q2 after 2025, the molecules of the anti-infection (hepatitis ...
- Source: drugdu
- 252
- December 16, 2024
【EXPERT Q&A】FDA small business application, what are the tips and guidelines?

Drugdu.com expert’s response: Ⅰ. FDA Small Business Application Guide Understanding the Definition and Benefits of FDA Small Business Definition of Small Business: A small business is defined as an applicant and its affiliates whose total gross annual sales or receipts for the most recent fiscal year do not exceed 100million(notlimitedtoU.S.businesses).Ifthetotalgrossannualsalesorreceiptsofasmallbusiness/affiliatedcompanydonotexceed30 million, it is eligible for a fee waiver for Premarket Approval (PMA) applications. Benefits: The FDA offers fee reductions for small businesses. For example, the small business fee for a 510(k) submission is 25% of the standard fee, which can save up to over $16,000 (the exact amount may vary by year). Preparing the Small Business Certification Application Application Form: The dedicated FDA application form (Form FDA 3602A MDUFA Foreign Small Business Certification Request) should be completed. The form should be opened using the latest version of Adobe Pro, and not domestic software such as WPS. Ⅱ. Application Process: Starting from ...
- Source: drugdu
- 385
- December 16, 2024
Xinlitai’s “Class 1 weight loss new drug” was approved for clinical trials in China

On December 11, according to the official website of CDE, Xinlitai’s Class 1 imported chemical drug DD01 injection obtained implicit approval for clinical trials and is intended to be used for weight management in obese adult patients or overweight patients with one or more weight-related risk factors (such as hypertension, type 2 diabetes or dyslipidemia). DD01 is a long-acting GLP-1R/GCGR dual agonist. In September 2021, Xinlitai introduced the drug from South Korea’s D&D Company for a total amount of no more than US$27 million. According to Xinlitai’s announcement, DD01 selectively activates GLP-1 receptors and GCGR receptors, excites downstream pathways, and produces biological effects such as lowering blood sugar, lowering body weight, lowering liver fat, lowering serum cholesterol, and improving liver function. Preclinical experimental studies have shown that compared with semaglutide, DD01 can not only achieve similar blood sugar lowering effects, but also has more obvious effects on improving fat metabolism ...
- Source: drugdu
- 316
- December 14, 2024
A world first! AstraZeneca “strikes a gold mine”

AstraZeneca recently announced that its PD-L1 monoclonal antibody Imfinzi has been approved by the FDA in the United States for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after concurrent platinum chemotherapy and radiotherapy, becoming the world’s first and only immunotherapy for LS-SCLC. In the ADRIATIC Phase III clinical trial, the average overall survival (OS) of the Imfinzi group was 55.9 months, and that of the placebo group was 33.4 months, a full 22.5 months increase. This is a very groundbreaking progress, breaking the LS-SCLC treatment bottleneck of more than 30 years. AstraZeneca “dug up the gold mine”, and its lung cancer treatment map has been further expanded. Expanding the lung cancer drug map Before 2000, there were only three means of treating lung cancer: chemotherapy, radiotherapy and surgery, especially for patients with advanced lung cancer, who had limited options. It ...
- Source: drugdu
- 338
- December 14, 2024
Wholly-owned Subsidiary’s CS12088 Clinical Trial Application Accepted

According to a news report on December 10, ChipScreen Biotech announced that its wholly-owned subsidiary, Chengdu ChipScreen Pharmaceuticals Co., Ltd., recently received the Acceptance Notice for the clinical trial registration of domestically-produced drugs issued by the National Medical Products Administration (NMPA) Drug Review Center. The clinical trial application for CS12088 has been accepted by the NMPA Drug Review Center. CS12088 is classified as an HBV core assembly modulator, featuring significant antiviral activity, liver-targeting characteristics, and good safety and tolerability. This medication works by interfering with the assembly of the HBV core, blocking the packaging of the viral pre-genomic RNA into the core, which in turn inhibits the replication of HBV DNA and suppresses the production of mature viral particles. The company will actively advance this research and development project and will strictly comply with relevant regulations to timely fulfill its disclosure obligations regarding the subsequent progress of the project. https://finance.eastmoney.com/a/202412103264202237.html
- Source: drugdu
- 240
- December 14, 2024
“Hanquyou” Debuts in the U.S. with First Commercial Supply

Recently, Henlius announced the shipping of its independently developed and produced biosimilar trastuzumab, “Hanquyou,” from the company’s Songjiang base to the U.S. market. This marks the first commercial supply to North America and represents another significant breakthrough in the company’s global strategic layout. With this, Henlius’ commercial supply network has successfully expanded to regions including China, Southeast Asia, North America, Europe, the Middle East, and Latin America. The international market expansion and high-quality development of Henlius are supported by the comprehensive lifecycle services provided by the Songjiang District. Leveraging the Shanghai Biomedical Registration Guidance Service Station, the district has proactively engaged to provide guidance and dedicated tracking, assisting biopharmaceutical companies like Henlius in accelerating drug research and production, which in turn promotes the vigorous development of the strategic emerging industrial cluster in Songjiang’s biopharmaceutical sector. Henlius’s product portfolio covers areas such as oncology, autoimmune diseases, and ophthalmology, with six products ...
- Source: drugdu
- 330
- December 14, 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.