Search Results for “FDA” – Page 80 – media

Heyuan Biotechnology Reports 34.22% Revenue Growth in the First Three Quarters; Performance Outlook Remains Positive

On the evening of October 23, Heyuan Biotechnology released its third-quarter report for 2024. In the third quarter, the company achieved a revenue of 70.81 million yuan, a year-on-year increase of 32.99%, but realized a net profit attributable to shareholders of -76.42 million yuan. For the first three quarters of this year, the company recorded a total revenue of 184 million yuan, marking a year-on-year growth of 34.22%, with a net profit attributable to shareholders of -190 million yuan. Improved Industry Environment Provides Growth Opportunities According to public data, Heyuan Biotechnology’s main business includes providing Contract Research Organization (CRO) services such as the development of gene therapy vectors and gene function research for cellular and gene therapy foundational research. It also offers Contract Development and Manufacturing Organization (CDMO) services, including application for Investigational New Drug-Chemistry, Manufacturing, and Controls (IND-CMC) pharmaceutical research and GMP production of clinical samples for the development ...
- Source: drugdu
- 41
- October 26, 2024
Fosun Pharma’s Global Innovation Journey

From November 5 to 10, 2024, the 7th China International Import Expo (hereinafter referred to as “CIIE”) will be held in Shanghai. This year marks the 30th anniversary of the founding of Fosun Pharma. As a “full-time student” of the 7th CIIE, Fosun Pharma will continue to work with global partners in the Medical Devices and Healthcare Exhibition Area of Hall 7.1 (Booth No.: 7.1B3-02) to demonstrate its strong strength and far-reaching influence in becoming a global leading medical innovation integrator. Wu Yifang, Chairman of Fosun Pharma, said: “Over the past 30 years, Fosun Pharma has always insisted on innovation-driven development, actively embraced globalization, and deepened international cooperation. We are in sync with the development of the pharmaceutical industry and have demonstrated our innovative achievements and global strategic layout through the CIIE, an important platform for open cooperation. We will continue to promote global operations, accelerate the transformation of source ...
- Source: drugdu
- 47
- October 26, 2024
1.596 billion, this pharmaceutical company was acquired

On the evening of October 21, Sichuan Shuangma announced that it plans to use its own and self-raised funds to acquire 92.1745% of Jianyuan Pharmaceutical’s equity for a total of 1.596 billion yuan. On October 22, Sichuan Shuangma opened at the daily limit, with a total market value of more than 14.3 billion yuan. Sichuan Shuangma was formerly known as Sichuan Shuangma Cement Co., Ltd. It was initially a building materials company focusing on the production and sales of cement products and building aggregates. It was listed on the main board of the Shenzhen Stock Exchange in 1999, and then gradually developed into a listed company engaged in industrial investment and private equity investment fund management. Its main managed assets include building materials manufacturing companies and private equity investment fund management companies. Sichuan Shuangma, born in the traditional industry, has not been optimistic about its recent development. The financial report ...
- Source: drugdu
- 37
- October 26, 2024
Baiyu Pharmaceutical announces exclusive licensing agreement with Novartis for a small molecule anti-tumor drug

On October 17th, Baiyu Pharmaceutical announced an exclusive licensing agreement with Novartis for a small molecule anti-tumor drug. According to the agreement, Baiyu will receive a down payment of 70 million US dollars (approximately 499 million yuan), as well as various milestone payments and corresponding royalties for development, registration, and commercialization up to 1.1 billion US dollars (approximately 7.8 billion yuan). Novartis will obtain exclusive global development and commercialization rights for this small molecule innovative drug. Founded in 2005, Baiyu Pharmaceutical is headquartered in Chengdu, Sichuan. It is a global pharmaceutical enterprise with innovative drugs as its core, integrating research and development, production, sales, and traditional Chinese medicine cultivation into a full industry chain group. 10 pipelines under research, 5 tumor pipelines According to the announcement, the asset of this transaction is a small molecule innovative drug for the treatment of malignant tumors invented and discovered by the Baiyu Innovative ...
- Source: drugdu
- 53
- October 25, 2024
Everest Medicines Announces Taiwan’s Approval of the World’s First New Drug Application for Nervosa® for the Treatment of IgA Nephropathy

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on the research and development, clinical development, manufacturing and commercialization of innovative drugs, announced today that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON® (budesonide enteric-coated capsules, NEFECON®) for the treatment of adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) at risk of progression to delay renal function decline by 1, with no baseline proteinuria level restriction. This means that NEFECON®, as the world’s first and only causal treatment for IgA nephropathy fully approved by the U.S. Food and Drug Administration (FDA), has further expanded its coverage, bringing new hope to more Chinese IgA nephropathy patients. The results of the NefIgArd Phase 3 global clinical trial showed that compared with placebo, NefIgArd® not only brought about a lasting decrease in proteinuria and reduced the risk of microscopic hematuria, but more importantly, it showed clinically relevant and statistically significant treatment ...
- Source: drugdu
- 56
- October 25, 2024
When Hengrui Medicine “gave up” going overseas independently

Going overseas is not only a dream, but also a big adventure that Hengrui Medicine has to take. Even under the new measurement standards, there is such a voice that the success of going overseas will be the key to determining whether Hengrui Medicine can maintain its “number one” status. Indeed, Hengrui Medicine, which has accelerated its innovation transformation, has come to a crossroads. First, relying on the domestic market in the past, Hengrui Medicine may not be in a hurry to layout overseas markets. However, with the involution of domestic innovative drugs and pharmaceutical companies going overseas to find incremental growth, internationalization has also been raised to a more important level. Although Hengrui Medicine proposed the direction of “internationalization” as early as in its 2020 annual report, its internationalization has not been smooth in the past few years. Secondly, carrelizumab has already fallen behind, and the internationalization of PD-1 ...
- Source: drugdu
- 51
- October 24, 2024
Jixing Announces that the National Medical Products Administration has accepted the New Drug Marketing Authorization Application for Aficamten Tablets

October 18, 2024, Shanghai, China – Jixing Pharmaceuticals (hereinafter referred to as “Jixing”), a biotechnology company committed to bringing innovative science and drugs to patients suffering from serious life-threatening cardiometabolic diseases, today Announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration has officially accepted the new drug marketing application for Aficamten tablets for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is a new generation of selective small molecule cardiac myosin inhibitor under development. Its treatment of oHCM has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and the China National Medical Products Administration. This new drug marketing application is based on the positive results of the pivotal global Phase 3 clinical study SEQUOIA-HCM. A total of 282 patients with obstructive HCM were enrolled in SEQUOIA-HCM. The study results showed that treatment with Aficamten significantly improved patients’ exercise capacity ...
- Source: drugdu
- 47
- October 24, 2024
【EXPERT Q&A】What is the process for registering apis in Saudi Arabia?

Drugdu.com expert’s response: Ⅰ. Preliminary Preparation and Research Before initiating the registration process, you need to: Conduct in-depth market research: Study the pharmaceutical market in Saudi Arabia to understand local demand for APIs, market size, and potential growth opportunities. Technical assessment: Evaluate whether your API product meets the quality and technical standards of Saudi Arabia. This includes assessments of production processes, quality control, stability, and other aspects. Regulatory familiarization: Thoroughly familiarize yourself with the registration requirements and processes of the Saudi Food and Drug Authority (SFDA) to ensure your product meets all relevant regulations. Ⅱ. Document Preparation and Submission Prepare registration documents: According to SFDA requirements, prepare complete registration documents, including product specifications, production process descriptions, quality control documents, stability study data, etc. Translation and notarization: If your documents are not in Arabic, they need to be translated into Arabic and notarized. Submit the application: Submit the registration application and ...
- Source: drugdu
- 57
- October 23, 2024
75.4 billion! Abbott’s Q3 performance exceeded expectations

Yesterday (October 17th), Abbott announced its third quarter 2024 financial report on its official WeChat account. Abbott’s global sales in the third quarter reached 10.6 billion US dollars (approximately 75.48 billion yuan), with an organic growth of 8.2% and a reported sales growth of 4.9%. Based on the brilliant performance in this quarter, Abbott said that after excluding the impact of COVID-19 testing products, the company expects global sales to achieve an organic growth of 9.5% to 10.0% in 2024, and diluted earnings per share after adjustment for the whole year may be between 4.64 and 4.70 dollars, the median of the range is higher than the previous estimate. Continuous growth achieved through multiple business operations According to the financial report, Abbott’s multiple departments have achieved business growth. Among them, the medical device department achieved double-digit growth, with global sales reaching $4.7 billion in the third quarter, an organic growth ...
- Source: drugdu
- 66
- October 23, 2024
7 Innovative Medical Devices Enter Special Review Process

Recently, the National Medical Products Administration’s Device Review Center released the results of the special review application for innovative medical devices (No. 9 of 2024), intending to approve 7 innovative medical device projects to enter the special review process.1. Liver low-temperature perfusion system: Hangzhou Lepusheng Medical Technology Co., Ltd Hangzhou Lepusheng Medical Technology Co., Ltd. (hereinafter referred to as Lepusheng Medical) was founded in 2016, focusing on the independent research and development of advanced medical devices for the protection, preservation, repair, and transportation of transplanted organs. It is committed to becoming a domestic benchmark and a global leading solution provider in the field of organ perfusion preservation and resuscitation. Since its establishment, Lepusheng Medical has made breakthroughs in core technologies such as organ perfusion protection and transport repair, and is opening up a new model for organ protection in China. The research and development focus of Lepusheng Medical is on ...
- Source: drugdu
- 59
- October 23, 2024

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