On March 24, CStone Pharmaceuticals announced that it had submitted a new indication application for Sugemalimab to the European Medicines Agency (EMA) for the treatment of patients with stage III non-small cell lung cancer. If approved, CStone Pharmaceuticals will further consolidate its position in the field of lung cancer immunotherapy. Rolling towards Europe Sugemalimab is a fully human, full-length anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. According to a press release from CStone Pharmaceuticals, the drug is a natural G-type immunoglobulin 4 (IgG4) monoclonal antibody drug that is closest to the human body. It can reduce the potential risk of immunogenicity and related toxicity in patients. Compared with similar drugs, Sugemalimab will have unique advantages. The drug was first approved for marketing in China in December 2021 for the first-line treatment of non-small cell lung cancer combined with chemotherapy. It has since been approved for multiple indications including lung cancer, ...
On March 24, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that the application for the listing of the 5.1 new drug lidocaine prilocaine aerosol jointly submitted by Plethora Solutions and Fosun Pharma was officially accepted. The drug’s trade name is Fortacin, which has been on the market in the EU for more than ten years and has been converted to OTC. If lidocaine prilocaine aerosol is approved, it will fill the gap in the field of premature ejaculation treatment in China, which has long relied on the oral drug dapoxetine, and provide patients with a new option of “one spray and immediate effect”. Premature ejaculation is one of the most common sexual dysfunctions in men, with an incidence rate of 2.3% among urban men in China. Currently, the only drug approved for the treatment of PE in China is ...
Drugdu.com expert’s response: Antibody-Peptide Conjugate (APC) is a specialized biopharmaceutical that links an antibody with a peptide through specific chemical bonds. This conjugate combines the targeting properties of the antibody with the biological activity of the peptide, enabling precise treatment of specific cells or tissues. Below is a detailed explanation of Antibody-Peptide Conjugate (APC): I. Definition and Structure Antibody-Peptide Conjugate (APC) is a complex formed by chemically linking an antibody and a peptide. The antibody is responsible for recognizing and binding to specific antigens on target cells or tissues, while the peptide carries therapeutically active molecules or groups. This structure allows APC to precisely target diseased sites while releasing therapeutic peptides, achieving localized high-concentration drug treatment. II. Preparation and Application Preparation Method: Antibody Reduction: Firstly, the interchain disulfide bonds of the antibody are reduced to produce thiol groups, providing active sites for subsequent conjugation reactions. Peptide Conjugation: Then, the chemically modified ...
Recently, Federal Biotech, a wholly-owned subsidiary of Federal Pharmaceuticals (03933. HK), reached an exclusive licensing agreement with multinational pharmaceutical giant Novo Nordisk for up to $2 billion (approximately RMB 14.5 billion, calculated at the latest exchange rate of 1 USD ≈ 7.2579 RMB). According to the agreement, Novo Nordisk will obtain the exclusive right to develop, produce and commercialize a weight loss drug UBT251 in the world outside Chinese Mainland, Hong Kong, Macao and Taiwan. Union Bio will receive a down payment of $200 million, a potential milestone payment of up to $1.8 billion, and a graded royalty based on net sales in Chinese Mainland, Hong Kong, Macao and Taiwan. UBT251 is a GLP-1 (glucagon like peptide-1)/GIP (glucose dependent insulinotropic polypeptide)/GCG (glucagon) triple target receptor agonist currently in early clinical development and has shown effective activity against all three receptors in preclinical settings. At present, UBT251 has been approved in ...
Recently, the US Food and Drug Administration (FDA) approved for the first time a system for cleaning complex internal channels of flexible endoscopes, which are stubborn sources of hospital acquired infections. This breakthrough was achieved by Nanosonics’ automated CORIS equipment. It is reported that Nanosonics’ CORIS device is specifically designed for stubborn biofilms formed in the narrowest areas of endoscopy. In the conventional reprocessing process, these areas cannot be touched by manual brushing. The residue composed of patient cells may gradually develop resistance to high-level disinfectants during multiple cleaning cycles. This Australian company pointed out that research on gastroscopy and colonoscopy has found biofilm residues in the microchannels of all devices, and some outbreaks of hospital acquired infections can be traced back to specific antibiotic resistant strains carried inside these reusable instruments. Previously, the FDA has urged medical technology developers and healthcare institutions to switch to endoscopic systems that contain ...
WuXi Biologics (02269), the world’s leading biopharmaceutical CDMO, handed in its 2024 report. The 2024 financial report shows that the company achieved annual revenue of 18.675 billion yuan, a year-on-year increase of 9.6%; net profit of 3.945 billion yuan, a year-on-year increase of 10.5%. After excluding COVID-19-related revenue, WuXi Biologics’ non-COVID-19 business achieved a year-on-year growth of 13.1%, showing the resilience of its fundamentals. It is worth noting that preclinical research service revenue increased by 30.7% year-on-year, accounting for 37.8% of total revenue, becoming the main force driving growth. In terms of regional revenue, North American market revenue increased by 32.5% year-on-year, contributing 57.3% of total revenue. But the other side of the coin is that the revenue in China fell by 9.6%, exposing the continued impact of the cold winter of local biotech financing. In 2024, WuXi Biologics’ gross profit margin increased by 0.9 percentage points year-on-year to 41%, ...
On the evening of March 25, CanSino Biologics released its 2024 annual report. The company achieved operating income of 846 million yuan for the whole year, an increase of 137.01% year-on-year; the net loss attributable to the parent company’s owners was 379 million yuan, and the loss narrowed by 74.45% year-on-year. Since its listing, CanSino Biologics, which has been losing money continuously, turned losses into profits in 2021 with the help of the new crown vaccine. As the competition for the new crown vaccine intensified and demand slowed down, it fell into losses again in the second year. Until 2024, CanSino Biologics has been losing money for three consecutive years. Increase in revenue from meningococcal vaccines The operating income in 2024 increased significantly, mainly due to the impact of the estimated return of the new crown vaccine in the same period of 2023, which reduced the operating income by 253 ...
The revenue scale of 11.812 billion yuan and the net profit level of 2.061 billion yuan were the operating results of Livzon Group on March 26 last year. This is also the first time since 2018 that the company’s net profit attributable to parent company has exceeded the integer mark of 2 billion yuan. In recent years, the overall performance of the pharmaceutical industry has been under pressure. The chemical preparation field of Livzon Group has also been affected by policies such as medical insurance negotiations and centralized procurement, including the sales revenue of key products such as ilaprazole sodium for injection and voriconazole for injection. However, as an innovative comprehensive pharmaceutical company, the company has maintained stable performance and operational resilience. According to the company’s 2024 annual report, the optimization of revenue structure, the continuous advancement of strong research and development, the continuous enrichment of product clusters, and the ...
Everest-B (01952.HK) achieved its sales target as planned. According to the annual performance announcement released on March 26, in 2024, Everest recorded revenue of 706.7 million yuan, a year-on-year increase of 461%; the loss during the year was 1.0414 billion yuan, compared with a loss of 844.5 million yuan in the same period last year, and the loss increased year-on-year. According to the announcement, Everest’s performance growth was mainly due to the sales of two commercial products, and the increase in losses was mainly due to the one-time, non-recurring impairment loss of intangible assets related to the mRNA COVID-19 vaccine in the first half of 2024. As of the end of 2024, Everest recognized the full impairment loss of US$50 million (equivalent to RMB 356.3 million) for the mRNA COVID-19 vaccine because it could not recover any economic benefits. Regarding the performance in 2024 and subsequent development, Luo Yongqing, CEO ...
Drugdu.com expert’s response: FSMA certification and BRC certification both occupy an important position in the food industry, but they differ significantly in multiple aspects. Here are the main differences between the two: I. Establishing Institution and Background FSMA certification: Implemented by the U.S. Food and Drug Administration (FDA), it stands for Food Safety Modernization Act certification. This certification was developed in response to the rapid changes in the global food system and the challenge of foodborne illnesses, aiming to ensure the safety of the food supply chain through preventive measures. BRC certification: Established by the British Retail Consortium (BRC), it was initially formulated for food producers supplying food to the UK. Subsequently, it has evolved into a global food safety standard widely used in food production and supply chain management worldwide. II. Scope of Application and Focus FSMA certification: Primarily targets food produced in the United States and imported into ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.