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21 Health News Daily | The actual controller and chairman of Yong’an Pharmaceutical have been detained; Ha Sanlian and related personnel received a warning letter from Heilongjiang Securities Regulatory Bureau

Large expansion of grassroots drug catalog On April 30th, the National Health Commission issued the “Guiding Opinions on Optimizing the Layout and Construction of Grassroots Medical and Health Institutions”, once again clarifying the need to expand the types of drugs used for common and chronic diseases at the grassroots level, and promote the unification of drug catalogs for county-level medical communities. The Opinion guides various regions to comprehensively coordinate the development of urban-rural integration, changes in population structure, and public health needs, and to improve the layout and construction of grassroots medical and health institutions according to local conditions. This is in line with the State Council executive meeting’s proposal to “improve the construction layout according to local conditions”. The core goal of the policy is to optimize resource allocation and improve service capabilities, promote the implementation of tiered diagnosis and treatment, and achieve a medical pattern of “minor ...
- Source: drugdu
- 67
- May 7, 2025
【EXPERT Q&A】What regulations and guiding principles are there for OOS investigations in pharmaceutical enterprises?

Drugdu.com expert’s response: Pharmaceutical companies are required to adhere to a series of regulations and guidelines when conducting investigations into Out-of-Specification (OOS) results. These documents provide a clear framework for the investigation process, responsibility allocation, and subsequent handling. The specifics are as follows: I. Core Regulatory Requirements FDA Regulations 21 CFR Part 211: Clearly stipulates Current Good Manufacturing Practices (CGMP) for pharmaceutical production and quality control, mandating the recording and investigation of any laboratory results that do not meet quality standards. FDA 211.192: Requires thorough investigations into OOS results. Even if a batch is rejected due to OOS, it is still necessary to determine whether the result is associated with other drugs or batches. FDA 211.194: Specifies that written records of investigations must include conclusions and follow-up actions to ensure process traceability. China GMP (Revised 2010 Edition): Article 224 mandates that quality control laboratories establish operating procedures for investigating out-of-specification ...
- Source: drugdu
- 55
- May 7, 2025
The Neuralink brain computer interface device has obtained FDA’s “Breakthrough Device” certification; Hengrui Pharmaceutical Passes Hong Kong Stock Exchange Listing Hearing | Pharmaceutical Early Participation

NO.1 Hengrui Pharmaceutical has passed the listing hearing on the Hong Kong Stock Exchange and may be listed as early as May On May 5th, the Hong Kong Stock Exchange website posted the PHIP version of Hengrui Pharmaceutical’s prospectus, which the market interpreted as indicating that Hengrui Pharmaceutical has officially passed the hearing of the Hong Kong Stock Exchange. Hengrui Pharmaceutical told the Daily Economic News reporter that this move marks a crucial progress for the company’s listing in Hong Kong. According to informed sources, Hengrui Pharmaceutical may be officially listed and traded on the Hong Kong Stock Exchange as early as May. Commentary: If Hengrui Pharmaceutical successfully goes public on the Hong Kong stock market this time, it will be its first equity financing after its A-share IPO and a key milestone in its internationalization strategy. From the current development trend of the pharmaceutical industry, overseas markets have ...
- Source: drugdu
- 60
- May 7, 2025
21 Health News Daily | The actual controller and chairman of Yong’an Pharmaceutical have been detained; Ha Sanlian and related personnel received a warning letter from Heilongjiang Securities Regulatory Bureau

On April 30th, the National Health Commission issued the “Guiding Opinions on Optimizing the Layout and Construction of Grassroots Medical and Health Institutions”, once again clarifying the need to expand the types of drugs used for common and chronic diseases at the grassroots level, and promote the unification of drug catalogs for county-level medical communities. The Opinion guides various regions to comprehensively coordinate the development of urban-rural integration, changes in population structure, and public health needs, and to improve the layout and construction of grassroots medical and health institutions according to local conditions. This is in line with the State Council executive meeting’s proposal to “improve the construction layout according to local conditions”. The core goal of the policy is to optimize resource allocation and improve service capabilities, promote the implementation of tiered diagnosis and treatment, and achieve a medical pattern of “minor illnesses not leaving the village and ...
- Source: drugdu
- 61
- May 7, 2025
ExpoMedical

Organiser：ExpoMedical Time：September 24-26, 2025 address：Av. Costanera R. Obligado and J. Salguero, Buenos Aires, Argentina Exhibition hall：Costa Salguero Exhibition Center Product range: Medical Equipment: Medical devices, electronic medical equipment, diagnostic instruments for various departments, testing instruments, medical optical instruments, X-ray equipment, imaging devices, scanning equipment, MRI machines, ultrasound diagnostic tools, clinical laboratory analysis instruments, hemodialysis equipment, dental equipment, anesthesia and respiratory devices, interventional diagnostic tools, dialysis equipment, etc. Medical Supplies: Disposable medical supplies, consumables, syringes, blood transfusion sets, sanitary napkins, band-aids, face masks, bandages, stethoscopes, medical ambulances, operating room supplies, scrubs, medical kits, gloves, various surgical knives, forceps, scissors, dental and orthopedic grinding/drilling tools, small electronic instruments, testing devices and accessories, orthopedic surgical technologies, medical beds, surgical and disinfection supplies, cleaning technologies, ambulance supplies, bandages, wound dressings, etc. First Aid Supplies: First aid equipment, emergency response devices, pharmaceutical products, medications, infusion solutions, disinfectants, blood derivatives, nutritional supplements, dermatological medications, veterinary ...
- Source: drugdu
- 65
- May 6, 2025
【EXPERT Q&A】What are the differences between the Class II filing and the Class III license for medical devices?

Drugdu.com expert’s response: Key Differences Between Class II Medical Device Filing and Class III Medical Device Licensing in China: Risk Tiers, Regulatory Approaches, Scope, Application Processes, and Oversight Intensity Medical devices in China are categorized into Class II (moderate risk) and Class III (high risk), with distinct regulatory frameworks governing their filing and licensing. Below is a detailed analysis of their disparities: I. Distinctions Between Class II Filing and Class III Licensing 1. Risk Tiers and Regulatory Approaches Class II Medical Devices: Risk Profile: Moderate risk, requiring stringent controls to ensure safety and efficacy. Regulatory Mechanism: Managed through a filing system, emphasizing post-market accountability. Class III Medical Devices: Risk Profile: High risk, with potential for severe health consequences. Regulatory Mechanism: Subject to pre-market licensing, necessitating rigorous pre-approval scrutiny. 2. Scope of Application Class II Medical Devices: Intended for extracorporeal prevention, diagnosis, monitoring, treatment, or alleviation of diseases. Examples include thermometers, sphygmomanometers, and hearing aids. Class ...
- Source: drugdu
- 73
- May 5, 2025
The “insulin leader” saw a 1150% surge in net profit

On April 25, Ganli Pharmaceutical, a leading insulin company, released its first quarter report for 2025, reporting an excellent performance with both revenue and net profit growing. According to the report, the company’s Q1 operating income reached 985 million yuan, a year-on-year increase of 75.76%; net profit attributable to shareholders of listed companies reached 312 million yuan, a year-on-year increase of 224.9%; net profit attributable to shareholders after deducting non-recurring items reached 215 million yuan, a year-on-year increase of 1150.2%. From the perspective of revenue structure, Gan & Lee Pharmaceuticals achieved significant growth in both domestic and overseas revenue, which jointly drove the increase in overall revenue. In the domestic market, Ganli Pharmaceuticals performed strongly, with sales revenue reaching 889 million yuan, an increase of 395 million yuan over the same period last year, a year-on-year increase of 80.07%. This is mainly due to the substantial increase in sales of ...
- Source: drugdu
- 76
- May 5, 2025
Yahong Pharmaceutical’s loss in the first quarter widened to 83.53 million yuan

On April 29, Yahong Pharmaceutical (688176) announced its first quarter report for 2025. The company’s operating income was 61.10 million yuan, up 151.2% year-on-year; the net profit attributable to the parent company changed from a loss of 82.85 million yuan in the same period last year to a loss of 83.53 million yuan, and the loss amount further expanded; the net profit attributable to the parent company after deducting non-recurring items changed from a loss of 93.23 million yuan in the same period last year to a loss of 89.35 million yuan, and the loss amount decreased; the net operating cash flow was -110 million yuan, up 14.5% year-on-year; EPS (fully diluted) was -0.1465 yuan. As of the end of the first quarter, the company’s total assets were 2.162 billion yuan, down 2.8% from the end of the previous year; the net assets attributable to the parent company were 1.891 ...
- Source: drugdu
- 88
- May 5, 2025
the core of stem cell therapy is safety, effectiveness and quality control

Shanghai Securities News (reporter Liu Yipeng) “At the beginning of this year, the first stem cell drug in China was approved for listing, marking a new stage of standardization and standardization of the industry. At present, many stem cell varieties have entered phase II and phase III clinical trials. Hainan Boao Music City International Medical Tourism Pioneer Zone has passed the policy of” first trial first “, providing an important test ground for clinical transformation.” On April 25, at the 2025 Boao Stem Cell Industry Conference, Wang Guangji, an academician of the CAE Member and professor of China Pharmaceutical University, said in an exclusive interview with reporters from Shanghai Securities News that the core of stem cell therapy is safe, effective and quality controllable, and only through strict standards. Only the stem cell products produced in chemical production, reviewed by the drug supervision department and clinically verified can truly benefit ...
- Source: drugdu
- 84
- May 4, 2025
The incidence of vaccine-preventable diseases is rising

According to the official website of the World Health Organization (WHO) on April 24, during the “World Immunization Week” held from the 24th to the 30th, WHO, UNICEF and the Global Vaccine Immunity Alliance jointly issued a warning that due to the spread of misinformation and the reduction of international aid, diseases that could have been prevented by vaccines, such as measles, meningitis and yellow fever, are on the rise worldwide. The three major international organizations urgently called on countries to continue to invest political attention and funds to consolidate the results of immunization programs and safeguard the significant progress made in reducing child mortality in the world over the past half century. The latest monitoring data show that measles cases have increased year by year since 2021. In 2023, there were 10.3 million cases, an increase of 20% from 2022. In the past 12 months, 138 countries have reported ...
- Source: drugdu
- 69
- May 4, 2025

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