PharmaFocus Today – Page 13 – media

One innovative medical device enters special review process

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 across the country: the fetal magnetocardiography of Mandi Medical Instruments (Shanghai) Co., Ltd. (hereinafter referred to as Mandi Medical). Fill the domestic gap Mandi Medical was founded in 2009 and is an innovative enterprise specializing in the research and development, production, and sales of biomagnetic medical imaging equipment. It is committed to becoming a global leader in China’s biomagnetic diagnostic solutions. Moreover, Mandy Medical is currently the first domestic enterprise to obtain the Shanghai CFDA medical device registration certificate for cardiac magnetic examination equipment. It has a series of core bio magnetic technologies, strong capital strength, and a first-class talent team. The magnetocardiogram (MCG) is a functional examination device that uses highly sensitive magnetic detectors to detect, collect, and ...
- Source: drugdu
- 64
- March 6, 2025
Driven by innovation and globalization, the revaluation of Aimi Vaccine is imminent

Recently, Aimi Vaccine (06660.HK) has successively issued two important announcements, marking the company’s significant progress in technological innovation and global layout. First, the company announced the access to the DeepSeek technology platform, actively responded to the national “AI+” industrial development strategy, and fully deployed the access to the DeepSeek large model. Through the localization strategy, it promoted the application of DeepSeekR1 version in all business scenarios of the group, and achieved “cost reduction, quality improvement, and efficiency increase” throughout the life cycle of vaccines. Secondly, Aimi Vaccine mRNARSV vaccine (respiratory syncytial virus vaccine) obtained the clinical approval of the US Food and Drug Administration (FDA), marking that the company’s R&D strength in the field of innovative vaccines has been internationally recognized. With strong R&D strength, diversified product portfolio and clear globalization strategy, Aimi Vaccine is accelerating its leapfrog development. Fosun International Securities predicted in its research report that in the ...
- Source: drugdu
- 69
- March 6, 2025
Last year, nearly 40% of influenza vaccines were scrapped. What exactly is the problem?

Recently, Jiemian News learned from insiders in the vaccine industry that the total number of influenza vaccines issued in 2024 will be about 80 million doses, and the actual vaccination volume will be about 50 million doses. The initial estimated scrap rate is about 40%. In fact, since 2018, with the promotion of policies and the improvement of public awareness, the overall number of influenza vaccines issued and vaccinated in my country has shown an upward trend, but the supply growth rate is significantly faster than the vaccination growth rate. That is, a mismatch between supply and demand has occurred. According to a report in Health Times in January 2018, Feng Zijian, former deputy director of the Chinese Center for Disease Control and Prevention, said at the “2018 Influenza Prevention and Control Work Press Conference” that the national supply market for influenza vaccines is about 26 million doses, and the ...
- Source: drugdu
- 77
- March 6, 2025
Fosun Pharma’s 24-valent pneumococcal vaccine clinical trial approved

On the evening of March 4, Fosun Pharma (600196) issued an announcement stating that the company’s holding subsidiary Fosun Antekin (Chengdu) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Fosun Antekin”) recently received approval from the National Medical Products Administration for clinical trials of 24-valent pneumococcal polysaccharide conjugate vaccine (application registration classification: preventive biological products 1.4; hereinafter referred to as “24-valent pneumococcal vaccine”). Fosun Antekin intends to conduct Phase I clinical trials of the vaccine in China (excluding Hong Kong, Macao and Taiwan) when conditions are met. https://finance.eastmoney.com/a/202503043336146495.html
- Source: drugdu
- 74
- March 6, 2025
structural mechanisms, clinical advantages, opportunities and challenges

Small molecule drug conjugates (SMDCs) are a new type of targeted therapy drug that originated from the optimization exploration of traditional chemotherapy and antibody-drug conjugates (ADCs). They aim to improve efficacy and reduce systemic toxicity through precise delivery, and have advantages in targeting, safety, and cost. Currently, no SMDC has been approved for marketing in the world. About 10 candidate drugs are in the clinical stage. Their indications are mainly solid tumors. They provide new strategies for drug-resistant tumors and are expected to expand to other disease areas. SMDC combines the flexibility of small molecule drugs with the synergistic potential of conjugation technology, promoting the evolution of tumor treatment towards high efficiency and low toxicity, and becoming a potential branch in the conjugated drug track. Mechanism of action of SMDC Small molecule drug conjugates (SMDCs) consist of three parts: small molecule targeting ligands, linkers, and payload drugs. Its mechanism of ...
- Source: drugdu
- 70
- March 6, 2025
Tonghua Dongbao’s net profit is expected to decrease by 99% in 2024. Can the transformation and survival break through?

Recently, Tonghua Dongbao corrected that the net profit attributable to shareholders of the listed company in 2024 was 11.6421 million yuan, a year-on-year decrease of about 99%. Previously, its forecast stated that the net profit for 2024 would be approximately 40.5277 million yuan, a year-on-year decrease of 96.53%. This correction stems from a lawsuit – the “Changshulin” trademark infringement case lost, and the compensation directly impacted the net profit. Due to losing the second instance lawsuit against Ganli Pharmaceutical for trademark infringement and abnormal competition, Tonghua Dongbao has recently received the final civil judgment and is required to bear compensation and litigation costs totaling over 60 million yuan. From the performance of Tonghua Dongbao in recent years, the reasons for its decline in performance are complex and diverse, including the price reduction of insulin procurement, inventory offsetting, asset impairment caused by the termination of research and development projects, and compensation ...
- Source: drugdu
- 95
- March 5, 2025
New indication for ustekinumab approved

On the evening of March 3rd, Huadong Pharmaceutical announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, had applied for the injection of ustekinumab (product name: Sailexin) ®， The supplementary application for the indication of plaque psoriasis in children (R&D code: HDM3001/QX001S) has been approved. HDM3001 (QX001S) is the original research product Stelara ® (Xidano) ®， The biosimilar drug of ustekinumab injection works by blocking the binding of the common p40 subunit of IL-12 and IL-23 to the IL-12R β 1 receptor protein on the surface of target cells, thereby inhibiting IL-12 and IL23 mediated signaling and cytokine cascade reactions. IL-12 and IL-23 are two naturally occurring cytokines that play a crucial role in immune-mediated inflammatory diseases. Stelara ® Developed by Johnson&Johnson in the United States, it was approved for market by the US Food and Drug Administration (FDA) in 2009. As of now, the approved indications in the ...
- Source: drugdu
- 69
- March 5, 2025
Why did the first mesenchymal stem cell drug in the United States set a “sky high price”!

Ryoncil adopts “spot type” cryopreservation technology, with a recommended dose of 2 × 10 ⁶ MSC/kg, administered twice a week (a total of 8 times). The single infusion is priced at 194000 US dollars (with a total cost of approximately 1.55 million US dollars). Many people naturally compare the price of mesenchymal stem cell drugs with that of CAR-T drugs. After all, a single dose of CAR-T in the United States costs over 400000 US dollars, making mesenchymal stem cells cheap. However, if calculated based on the course of treatment, Ryoncil would cost 10 million RMB, which is simply astonishing! We also acknowledge that Ryoncil has a nearly 30-year research and development cycle, with a cumulative investment of over 1 billion US dollars. The company wants to recover its costs as soon as possible. In addition, the research and development company Mesoblast was rejected by the FDA twice in 2020 ...
- Source: drugdu
- 80
- March 5, 2025
One innovative medical device enters special review process

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 disposable endoscopic anastomosis clip system of Guangzhou Yulin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Yulin Pharmaceutical). Accelerate the process of domestic substitution Yulin Pharmaceutical was founded in 2011 and is a technology-based medical enterprise that integrates research and development, production, sales, and after-sales service. Currently, it holds one US invention patent and more than ten domestic utility model and design patents. The factory is equipped with a 100000 level sterile production workshop and complete production facilities. Focusing on the field of obstetrics and gynecology, we are committed to providing simple and convenient clinical consumables. According to Yaozhi Patent Communication, currently Yulin Medicine has 8 authorized patents and 5 patents in the approval process, covering fields ...
- Source: drugdu
- 76
- March 5, 2025
Kangtai Biological received the summary report of the Phase I/III clinical trial of adsorbed tetanus vaccine

On the evening of March 3, Kangtai Biological (300601) issued an announcement stating that the company’s wholly-owned subsidiary Beijing Minhai Biotechnology Co., Ltd. (hereinafter referred to as “Minhai Biotechnology”) recently received the summary report of the Phase I/III clinical trial of adsorbed tetanus vaccine, and the clinical research phase of the adsorbed tetanus vaccine developed by Minhai Biotechnology was successfully completed. The results of the study showed that the adsorbed tetanus vaccine developed by Minhai Biotechnology has good safety and immunogenicity for adult immunization. Kangtai Biological said that the acquisition of the summary report of the Phase I/III clinical trial of the adsorbed tetanus vaccine shows that the adsorbed tetanus vaccine has the necessary conditions for application for production, which is of great significance to the development of the company. https://finance.eastmoney.com/a/202503033334982519.html
- Source: drugdu
- 74
- March 5, 2025

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