PharmaFocus Today – Page 2 – media

Domestic PD-L1 goes overseas again

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, ...
- Source: drugdu
- 29
- March 31, 2025
Big news! A new premature ejaculation drug that works in one spray is launched, and Fosun Pharma enters the billion-dollar market

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 ...
- Source: drugdu
- 30
- March 31, 2025
14.5 billion yuan! Novo Nordisk authorizes domestic GLP-1/GIP/GCG agonists

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 ...
- Source: drugdu
- 44
- March 28, 2025
1 Medical Device Approved by FDA

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 ...
- Source: drugdu
- 48
- March 28, 2025
$18.5 billion in unfinished orders in 2024, convertible into $3.7 billion within three years

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%, ...
- Source: drugdu
- 50
- March 28, 2025
CanSino Biologics lost 379 million yuan last year and made a profit only one year after its listing

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 ...
- Source: drugdu
- 47
- March 28, 2025
Net profit attributable to parent company exceeds 2 billion for the first time. How did Livzon Group achieve “centralized procurement and immunity”?

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 ...
- Source: drugdu
- 44
- March 28, 2025
Although the flagship product sold over 700 million, Everest suffered a loss of over 300 million due to the COVID-19 vaccine. This year, it will expand the sales team of kidney disease targeted drugs

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 ...
- Source: drugdu
- 40
- March 28, 2025
A medical device is scheduled for priority approval

According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities nationwide: the strong pulse light therapy device of Dayue Innovation (Suzhou) Medical Technology Co., Ltd. (hereinafter referred to as Dayue Medical). Domestic brands are catching up Intense pulsed light (IPL), also known as pulsed light, is one of the most widely used phototherapy techniques in clinical practice and plays a very important role in the field of skin beauty. Its wavelength is mostly between 500-1200nm. At present, IPL is widely used in the treatment of various skin diseases, especially those related to photodamage and photoaging, namely the classic Type I and Type II skin rejuvenation. According to research, the theoretical basis for using strong pulsed light for skin treatment is mainly based on the principle of selective photothermal action. ...
- Source: drugdu
- 46
- March 27, 2025
481 models! 2024 FDA orphan drug certification explosion! China ranks second

According to the official website of the FDA, a total of 481 drugs obtained FDA orphan drug certification in 2024. Previously, the highest value of this number was 477. In fact, compared to over a decade ago, the number of drugs that have received FDA ODD has doubled in recent years. According to statistics, the total number of FDA ODDs since 1983 has been 7306. Among them, the number of drugs that have obtained FDA ODD has exceeded 100 since 2004 and has been increasing year by year since then. By 2017, the number of drugs that received FDA ODD had skyrocketed to 477. Between 2019 and 2023, the overall number of FDA ODDs obtained remained between 335 and 475. The number of drugs that have obtained FDA ODD in 2024 has broken through from the previous 2017 data, reaching 481. According to the latest data, although it has only ...
- Source: drugdu
- 47
- March 27, 2025

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