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Biosafety Bill encounters setback again

The Biosafety Bill, which the biotech industry is most worried about, has made new progress. On December 7, the shoe finally dropped: the relevant provisions of the Biosafety Bill did not appear in the final negotiation text of the 2025 National Defense Authorization Act (“NDAA”) after consultation by members of the Senate Armed Services Committee. This shows that the attempt to include the Biosafety Bill in the 2025 NDAA has failed, and it will not pose an obstacle to the overseas expansion of companies such as BGI in the short term. This is the case in the short term, and it is likely to be the case in the long term. In the eyes of the market, this is not the end, and there is still a possibility of being mentioned again in the future. This is the case in theory, but in fact, the “abortion” of the Biosafety Bill ...
- Source: drugdu
- 39
- December 18, 2024
Oral peptides are on the rise

Next, let’s turn our attention to the international stage and first focus on AbbVie’s latest merger and acquisition. On December 13, AbbVie announced that it would acquire privately held company Nimble Therapeutics for $200 million in cash, targeting a preclinical development of an investigational oral peptide IL23R inhibitor for the treatment of psoriasis, as well as other new oral peptide products for various autoimmune diseases. This also highlights a trend that the oral peptide market is beginning to rise in the autoimmune treatment market. In the field of oral peptide IL23R inhibitors, there was good news in November: Johnson & Johnson announced that the ICONIC-LEAD clinical study obtained top-line results, which means that the world’s first targeted oral peptide Icotrokinra that selectively blocks IL-23 receptors will soon be on the market. From a clinical positioning perspective, oral peptide drugs are a good supplement to injectable preparations due to their compliance ...
- Source: drugdu
- 35
- December 18, 2024
【EXPERT Q&A】Can imported medical devices be commissioned to domestic third party production?

Drugdu.com expert’s response: The direct commissioning of domestic third-party production for imported medical devices is not permitted. This regulation is primarily based on the stringent quality control and regulatory requirements for medical device production. Due to the differences in medical device regulatory systems across different countries and regions, directly commissioning domestic third-party production may pose risks in terms of quality and regulation. However, the registrant of imported medical devices can produce Class II and Class III medical devices that have already obtained imported medical device registration certificates within China through a foreign-invested enterprise established within the territory. This approach requires meeting certain conditions, such as no changes to the product design and maintaining a consistent quality system, to ensure that there are no significant changes to the safety and effectiveness of the products. Additionally, the original imported registration certificate must be valid; if it has expired or been cancelled, it ...
- Source: drugdu
- 73
- December 18, 2024
Expopharm-Mexico

Organiser：Mexican Pharmaceutical Association Time：April 17th – 19th, 2025 Address：Conscripto 311, Colonia Lomas de Sotelo, Delegación Miguel Hidalgo, 11200, México D.F. Exhibition hall：Centro Banamex Product range: API Equipment: Reaction equipment, drying equipment, crystallization equipment, centrifuges, extraction equipment, heat exchangers, storage equipment, filtration equipment, evaporation equipment, distillation equipment, screening machinery, sterilization equipment, filter press equipment, homogenizers, etc. Pharmaceutical Preparation Equipment: Pill machinery, ointment machinery, eyedrop machinery, tablet machinery, tincture and syrup machinery, granule machinery, soft capsule machinery, aqueous injection machinery, hard capsule machinery, suppository machinery, oral liquid machinery, medicinal film machinery, aerosol machinery, antibiotic powder machinery, aqueous injection machinery, infusion machinery, tablet pressing machines, coating machines, medicinal filling machines, air jet mills, pharmaceutical grinding machines, mechanical pharmaceutical crushing machines, ultra-fine grinding machines, granulating machines, mixing equipment, bottle conveyors, bottle aligning machines, oscillating capping devices, feeding devices, etc. Pharmaceutical Packaging Machinery: Weighing equipment, bag packaging machines, pillow packaging machines, blister packaging machines, ...
- Source: drugdu
- 73
- December 17, 2024
2024 SABCS | Zhengda Tianqing Announces the Latest Data of Arrotinib Treatment for breast cancer

The 47th San Antonio breast cancer Symposium (SABCS) in 2024, held in the United States from December 10 to 13, is one of the largest and most prestigious academic events in the field of breast cancer research. At this conference, Zhengda Tianqing focused on HR+/HER2- and triple negative breast cancer, and released a number of clinical research data based on arotinib. The objective response rate (ORR) of the triple negative breast cancer study, which is called “the most toxic breast cancer”, is as high as 75.0%; The disease control rate (DCR) in the treatment of breast cancer patients with CDK4/6 inhibitor resistant HR+breast cancer was 94.9%. Efficacy and safety of the first-line treatment of advanced triple negative breast cancer with arotinib combined with paianzulimab and albumin bound paclitaxel: a prospective, phase II clinical study Forty three patients with inoperable locally advanced or recurrent/metastatic triple negative breast cancer (TNBC) with an ...
- Source: drugdu
- 47
- December 17, 2024
Maiwei Biotechnology and Chongqing High tech Zone Management Committee plan to invest 2 billion yuan in the construction of the “Bone Health Innovative Drug Project”

On December 16th, Shanghai Stock Exchange China Securities Network (Reporter Wang Mopujia) announced that Maiwei Biotechnology has signed a “Maiwei Biotechnology Bone Health Innovation Drug Project Contract” with the Chongqing High tech Industrial Development Zone Management Committee (referred to as “Chongqing High tech Zone Management Committee”) and the Chongqing Zhongxin Pharmaceutical Big Health Private Equity Investment Fund Partnership Enterprise (Limited Partnership) (referred to as “Big Health Fund”). Maiwei Biotechnology (Chongqing) Co., Ltd. (referred to as “Maiwei Chongqing”), a wholly-owned subsidiary of the company, will jointly invest in and construct the “Maiwei Biotechnology Bone Health Innovation Drug Project” as the project operating entity. It is reported that the total planned investment for the above-mentioned project is 2 billion yuan, of which Maiwei Biotechnology has a total investment of no less than 1.6 billion yuan (1.008 billion yuan in this round of investment), which will be contributed in the form of ...
- Source: drugdu
- 43
- December 17, 2024
Liu Yongjun resigns from CSPC

Liu Yongjun resigned at the speed of light. On December 9, according to media reports, Liu Yongjun had resigned from CSPC, just three months after the official announcement of joining. On September 9 this year, CSPC issued an announcement on the Hong Kong Stock Exchange, announcing the appointment of Liu Yongjun as the group’s executive president and global R&D president, responsible for the group’s R&D, pipeline strategy and international business development. It may be rare in the industry for a senior executive in this position to resign within three months. Combined with a series of personnel, capital and innovation strategy changes from CSPC to its innovative pharmaceutical subsidiary in the past three months, it can be seen that CSPC may be facing certain challenges in innovation, R&D, and internationalization. This also highlights the fact that the transformation of most traditional pharmaceutical companies may end in failure. After all, innovation cannot ...
- Source: drugdu
- 40
- December 17, 2024
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
- 33
- 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
- 41
- 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
- 46
- December 16, 2024

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