PharmaFocus Today – Page 118 – media

Over 130 million US dollars! Henlius and Dr Reddy’s has reached a European and American authorized cooperation on the biosimilar drug of daratumumab

On February 6, 2025, Henlius (2696. HK) announced its partnership with Dr Dr., a wholly-owned subsidiary of Reddy’s Laboratories Reddy’s Laboratories SA has signed an authorization license agreement for the company’s self-developed biosimilar drug HLX15 (recombinant anti-CD38 whole human monoclonal antibody injection). Dr. Reddy’s Laboratories (and its subsidiaries collectively referred to as “Dr. Reddy’s”) is listed on the Mumbai Stock Exchange (stock code: 500124) and the National Stock Exchange of India (stock code: DRREDDY）、 The New York Stock Exchange (stock code: RDY）、 The International Financial Services Centre of the National Stock Exchange of India (stock code: DRREDDY) is listed. Dr. Reddy’s will have exclusive commercial rights to HLX15 subcutaneous and intravenous formulations in the United States and 42 European countries and regions, covering a total of 43 countries and regions. According to the terms of the agreement, Henlius will be responsible for the research and development, production, and commercial supply ...
- Source: drugdu
- 289
- February 11, 2025
Namixin announces completion of Series A financing, focusing on research and development of mRNA vaccines/drugs

On February 10, 2025, Namixin (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as “Namixin”) announced the completion of its Series A financing. This financing is jointly invested by Chengdu Bio City Guosheng Capital and Enran Venture Capital. The financing funds will mainly be used to promote clinical research of the NR222 project and the development of new projects. The implementation of this round of financing is a recognition of Namixin by the investors and injects strong impetus into the company’s promotion of subsequent clinical research. Namixin was founded in 2021 and registered in Lingang, Shanghai. It is a biotechnology enterprise specializing in the research and development of new vaccines/drugs in the mRNA field. The founding team of the company has a profound research background in the mRNA field and has held important positions in top pharmaceutical research institutions and pharmaceutical companies both domestically and internationally, effectively mastering the core know-how ...
- Source: drugdu
- 257
- February 11, 2025
The vaccination market for middle-aged and elderly people is still waiting to be opened up for the application of another domestically produced herpes zoster vaccine for market launch

The domestic herpes zoster vaccine market is about to enter the “Three Kingdoms Kill”. On the evening of February 9th, Green Bamboo Biotechnology (02480. HK) announced that its application for the marketing of its recombinant herpes zoster vaccine LZ901 has been accepted by the National Medical Products Administration. If successfully launched, this vaccine will become the third herpes zoster vaccine to be launched in China. Currently, there are two herpes zoster vaccines on the market, one of which is a domestically produced vaccine manufactured by BioNTech; One is an imported vaccine, manufactured by GlaxoSmithKline. Herpes zoster is an infectious skin disease caused by the reactivation of varicella zoster virus that has long been lurking in the posterior root ganglia or cranial ganglia of the spinal cord. As people grow older, their physiological and metabolic functions and immune functions gradually decline, and the risk of suffering from infectious diseases such as ...
- Source: drugdu
- 208
- February 11, 2025
Last year, semaglutide sales were nearly $30 billion, and the Chinese market will soon face challenges

Novo Nordisk recently released its 2024 financial report. During the reporting period, Novo Nordisk achieved revenue of 290.403 billion Danish kroner (approximately $42.137 billion, calculated at 1 Danish kroner = $0.1451, the same below), a year-on-year increase of 25%; net profit was 100.988 billion Danish kroner (approximately $14.653 billion), a year-on-year increase of 21%. The total annual revenue of its three semaglutide products was 201.849 billion Danish kroner (approximately $29.288 billion), a year-on-year increase of nearly 40%, approaching the sales of Merck’s “king of medicine” K drug (pembrolizumab) of $29.486 billion in 2024. In 2024, Novo Nordisk’s diabetes and obesity treatment sales achieved revenue of 271.764 billion Danish kroner (about 39.433 billion U.S. dollars), a year-on-year increase of 26%. The growth was mainly driven by the GLP-1 diabetes treatment field and the obesity treatment field. Among them, the sales of GLP-1 diabetes treatment field increased by 21% in Danish kroner, ...
- Source: drugdu
- 617
- February 11, 2025
Hansoh Pharmaceutical’s product Xinyue’s new indication is included in the priority review and approval process by NMPA

On February 10, Hansoh Pharmaceutical (03692) issued an announcement, announcing that its product Xinyue® (inelizumab injection) was included in the priority review and approval process by the National Medical Products Administration (NMPA) on February 8, 2025 for the new indication of treating immunoglobulin G4-related diseases (IgG4-RD) due to the positive results of the global pivotal Phase III trial MITIGATE. Xinyue® signed a license agreement with Viela Bio on May 24, 2019, obtaining exclusive licenses for development and commercialization in mainland China, Hong Kong and Macau. The product was approved for marketing by NMPA on March 14, 2022, and is suitable for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin 4 (AQP4) antibodies. In January 2023, the product was included in the “National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug List” for the first time and was successfully renewed in November 2024. https://finance.eastmoney.com/a/202502103314676122.html
- Source: drugdu
- 238
- February 11, 2025
Luzhu Biotech’s Core Product BLA Application Accepted by China’s National Medical Products Administration

Luzhu Biotech-B (02480) announced that the Biologics License Application (BLA) for its core product, LZ901, has recently been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China. This milestone marks a significant step forward in the company’s development of a recombinant shingles vaccine (CHO cell). LZ901 is designed to prevent shingles and related complications, including postherpetic neuralgia, in adults aged 40 and above. The vaccine successfully achieved its predefined objectives and delivered expected clinical results in Phase III clinical trials in China. According to the announcement, after the BLA acceptance, the NMPA will conduct technical reviews, clinical trial site inspections, and manufacturing site inspections to assess the feasibility of the application. However, it is important to note that despite the smooth progress of LZ901’s development, the company cannot guarantee the product’s eventual success in development and commercialization. Shareholders and potential investors are advised to exercise ...
- Source: drugdu
- 292
- February 11, 2025
Exclude products with higher quality risks from centralized procurement

In January this year, some experts believed that some centralized procurement drugs may have quality risks of “blood pressure does not drop, anesthetics do not cause sleep, and laxatives do not cause diarrhea”. Relevant departments quickly sent personnel to investigate and understand the situation. Recently, relevant comrades from the medical insurance and drug supervision departments who participated in the investigation accepted media interviews on issues of social concern. Is there a quality problem on the Internet? Regarding the saying that “antihypertensive drugs do not lower blood pressure”. It is reported that the generic drugs of “amlodipine” are not as effective as the original drugs, and the reason is personal medication experience. Ruijin Hospital provided the clinical real-world research results of the comparison between the selected generic drugs and the original drugs in the centralized procurement of amlodipine besylate in which the hospital participated, showing that “for patients with primary hypertension, ...
- Source: drugdu
- 308
- February 11, 2025
The product has been on the market for less than a year, and all other pipelines have been cut off

The financial pressure is now causing concern among some biotech companies that have already launched their products. Recently, X4 Pharmaceuticals announced that it will lay off 43 employees, accounting for approximately 30% of its global workforce. This wave of layoffs includes the closure of the “Center of Excellence” located in Vienna, Austria, and the suspension of the development of all preclinical drug candidates. Layoffs and business downsizing will save the company $30 million to $35 million. This company just welcomed the launch of its core pipeline XOLREMDI (mavorixafor) less than a year ago (April last year), however, the product launch does not mean that X4 has reached the safe line of cash flow. According to last year’s Q3 financial report, excluding XOLREMDI’s revenue, X4 company’s cash is only sufficient to operate until the end of 2025. However, after layoffs and integration, X4 is expected to extend its cash flow to ...
- Source: drugdu
- 298
- February 10, 2025
Fuhong Hanlin’s Pertuzumab Biologics License Application Accepted by FDA

On February 8, Fuhong Hanlin (02696) announced that the company’s independently developed Pertuzumab biosimilar HLX11’s Biologics License Application (BLA) has been accepted by the U.S. Food and Drug Administration (FDA). The application involves indications including combination with trastuzumab and docetaxel for the treatment of HER2-positive metastatic breast cancer patients who have not received anti-HER2 treatment or chemotherapy for metastatic disease, and as part of the overall treatment of early breast cancer for neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early breast cancer patients. HLX11 is a biosimilar independently developed by the company, intended for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, treatment of HER2-positive metastatic breast cancer, etc. According to the industry guidelines issued by the FDA, the BLA submitted this time is based on the data generated by HLX11 compared with Perjeta®, including similarity studies and phase III clinical comparison studies. According to data provided by ...
- Source: drugdu
- 263
- February 10, 2025
Merck suspends supply to China, domestic nine-valent HPV vaccine has not yet been launched

Recently, Merck announced in a earnings call after the disclosure of its financial report that it would suspend the supply of HPV vaccines to China until mid-2025 or longer. This is undoubtedly extremely explosive news. You must know that Merck’s quadrivalent and nine-valent HPV vaccine sales achieved US$8.9 billion in sales in 2023, of which 60%-70% came from the Chinese market. Its chairman and CEO Rob Davis even proposed a goal of exceeding US$11 billion in sales in 2030. Why did Merck do this, and what chain reactions will the domestic vaccine market and vaccine manufacturers have as a result? Overdrawn market, weak subsequent growth In the earnings call, Rob Davis bluntly stated that the sales dynamics of Merck’s HPV vaccine product Gardasil in China in 2025 are still challenging, and market demand has not yet returned to the company’s expectations, so the overall channel inventory is still higher than ...
- Source: drugdu
- 263
- February 10, 2025

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