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The first nasal “dry eye” treatment drug is approved for marketing

On November 27, Jixing Pharmaceutical announced that the National Medical Products Administration has approved the new drug application for its ophthalmic product, Varenicline tartrate nasal spray, to increase the tear secretion of patients with dry eyes. According to the data of “Chinese Dry Eye Expert Consensus (2020)”, the current incidence of dry eye in my country is about 21%-30%. Dry eye is closely related to excessive eye use, wearing contact lenses and other lifestyle habits. Common symptoms include dry eyes, foreign body sensation, burning sensation, itchy eyes, pain, red eyes, visual fatigue, blurred vision, and vision fluctuations. Natural tear deficiency and tear film instability are the core mechanisms of dry eye. Varenicline tartrate nasal spray is a highly selective acetylcholine receptor agonist that promotes natural tear secretion to stabilize the tear film by activating the trigeminal parasympathetic pathway. The approval data is based on the results of three key clinical ...
- Source: drugdu
- 153
- December 2, 2024
CAR-T, a special medicine for tumors, is out of the medical insurance again

On November 28, the results of the 2024 medical insurance catalog negotiation were announced: 91 new drugs were added to the national medical insurance drug catalog, of which 89 were included by negotiation/bidding, and another 2 were selected in the national centralized procurement. After checking the medical insurance drugs, Sina Medical Editor found that the 4 CAR-T products that had passed the preliminary review did not appear on the list. Regarding “Why is it difficult for CAR-T to enter the medical insurance catalog”, at the press conference held by the National Medical Insurance Administration on the morning of November 28, Wang Guodong, deputy director of the Medical Insurance Management Center of the National Medical Insurance Administration, introduced that some expensive cell and gene therapy drugs have been launched one after another, and it is difficult to fully support them by relying solely on basic medical insurance. At present, the National ...
- Source: drugdu
- 74
- December 2, 2024
CanSino Biologics’ Quadrivalent Meningococcal Conjugate Vaccine Age Extension Application Accepted by the National Medical Products Administration

According to CanSino’s official WeChat account, the supplemental application for CanSino Biologics’ ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 carrier), referred to as “Mankexin®,” has been accepted by the National Medical Products Administration (NMPA) and a notice of acceptance has been issued. This supplemental application expands the age range for the use of Mankexin® from “3 months to 3 years (47 months) children” to “3 months to 6 years (83 months) children.” Mankexin® received approval from the NMPA on December 29, 2021. https://finance.eastmoney.com/a/202411263251192857.html
- Source: drugdu
- 89
- December 2, 2024
【EXPERT Q&A】Medical device risk estimation, risk assessment, risk rating, what is it, what is the difference?

Drugdu.com expert’s response: In the field of medical devices, risk estimation, risk assessment, and risk rating are crucial steps in risk management, each with its own clear definition and distinction. Ⅰ. Definitions 1. Risk Estimation （1）Definition: The process of assigning values to the probability of occurrence and severity of harm. （2）Content: This typically involves analyzing factors such as the design, manufacturing process, and usage environment of medical devices to identify potential risk points. The purpose of risk estimation is to identify potential risks and provide a foundation for subsequent risk assessment. 2. Risk Assessment （1）Definition: The process of comparing “estimated risks” with “given risk criteria” to determine the acceptability of risks. （2）Content: Risk assessment is a more in-depth and systematic process that involves detailed analysis of identified risks, including the likelihood, severity, and effectiveness of risk control measures. The purpose of risk assessment is to determine the priority of risks ...
- Source: drugdu
- 140
- December 2, 2024
400 million antibacterial injections, Huiyu Pharmaceutical has won the first imitation!

On November 27th, according to the official website of NMPA, Sichuan Huiyu Pharmaceutical’s application for the marketing of four types of generic drugs – morpholine nitrate sodium chloride injection – was approved and deemed to have passed the consistency evaluation, becoming the first domestic generic drug. At present, only Jiangsu Haosen Pharmaceutical Co., Ltd. has been approved as a new drug Class 1.1 for the injection of sodium methoxam and sodium chloride. There are currently no other companies approved for Class 4 generic drugs in China. Morpholinenidazole sodium chloride injection is mainly used for antibacterial and anti-inflammatory purposes. It belongs to the third generation of nitroimidazole antibacterial drugs, and the national medical insurance class B, which is used to treat pelvic inflammation, appendicitis and other infectious diseases. It has a strong antibacterial effect on anaerobic bacteria and is widely used in clinical practice. According to the Moen Pharmaceutical Database, the ...
- Source: drugdu
- 153
- November 30, 2024
China Resources Pharmaceutical Commercial and Pfizer officially sign a strategic cooperation agreement

On November 26th, China Resources Pharmaceutical Commercial and Pfizer officially signed a strategic cooperation agreement, in which Pfizer will hand over the commercial operation of four heavyweight cancer products in China to China Resources Pharmaceutical Commercial. 01. China Resources wins commercial promotion authorization for four heavyweight cancer drugs On November 26th, China Resources Pharmaceutical Commercial and Pfizer officially signed a strategic cooperation agreement, in which Pfizer will hand over the commercial operation of four heavyweight cancer products in China to China Resources Pharmaceutical Commercial. According to the “Pharmaceutical Representative”, the cooperation will officially begin on December 1st. Employees affected by this cooperation will go to Shanghai for offline communication, and the final employee placement will be completed by the end of next month. The four drugs involved in this transaction have been in the Chinese market for many years, namely AROMASIN, IBRANCE, Pharmarubicin RD, and XALKORI. Among them, Famax was ...
- Source: drugdu
- 149
- November 30, 2024
The first national pharmaceutical public REITs, leading the new development of the pharmaceutical industry

Real estate securitization (REITs) brings about the “three new” trends On November 7th, at the sub forum of the 3rd Green Finance Forum in 2024, Jiuzhou Tong, a leading pharmaceutical circulation enterprise, shared the “three new” trends brought by real estate securitization (REITs). What are the ‘three new’? According to Su Xiling, Deputy General Manager of Jiuzhou Tong Pharmaceutical Group Co., Ltd. and Head of Jiuzhou Production and Investment, firstly, there is a new financing model. REITs, as innovative, non stock, non debt equity financing, provide new financing channels for enterprises, which is conducive to building new production and financing platforms and providing new investment products for the capital market; Secondly, there is a new driving force for development. After the successful issuance of Kyushu Tong’s public REITs, about 80% of the raised funds will be used for infrastructure construction in areas such as pharmaceutical warehousing; The third is the ...
- Source: drugdu
- 141
- November 30, 2024
China Resources Group announces heavyweight cooperation

On November 26th, China Resources Pharmaceutical Commercial and Pfizer officially signed a strategic cooperation agreement, in which Pfizer will hand over the commercial operation of four heavyweight cancer products in China to China Resources Pharmaceutical Commercial. 01 China Resources wins commercial promotion authorization for four heavyweight cancer drugs On November 26th, China Resources Pharmaceutical Commercial and Pfizer officially signed a strategic cooperation agreement, in which Pfizer will hand over the commercial operation of four heavyweight cancer products in China to China Resources Pharmaceutical Commercial. According to the “Pharmaceutical Representative”, the cooperation will officially begin on December 1st. Employees affected by this cooperation will go to Shanghai for offline communication, and the final employee placement will be completed by the end of next month. picture The four drugs involved in this transaction have been in the Chinese market for many years, namely AROMASIN, IBRANCE, Pharmarubicin RD, and XALKORI. Among them, Famax ...
- Source: drugdu
- 87
- November 30, 2024
CSPC Pharmaceuticals’ Ustekinumab is listed

Today (November 26), according to the official website of CDE, Shijiazhuang Pharmaceutical Group’s application for listing of Class 3.3 new drug “Ustekinumab Injection” has been accepted. Ustekinumab is a monoclonal antibody targeting the IL12/23 p40 subunit. It is understood that IL-12 and IL-23 are two naturally occurring cytokines that play a key role in immune-mediated inflammatory diseases. Ustekinumab can inhibit the signal transduction and cytokine cascade mediated by the two cytokines by binding to the p40 subunit shared by the two cytokines and preventing it from binding to the cell surface receptor IL-12β1. The original product of ustekinumab injection was developed by Johnson & Johnson. Since its approval for marketing, its annual sales have continued to grow. In 2023, the global sales of this product successfully exceeded the US$10 billion mark, reaching US$10.858 billion. According to the drug clinical trial registration and information disclosure platform, Shijiazhuang Pharmaceutical Group’s ustekinumab injection ...
- Source: drugdu
- 117
- November 30, 2024
The medical insurance list is released, and the treatment of rejection after transplantation ushers in a new pattern

Today, the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug List (2024) (hereinafter referred to as the “New Medical Insurance List”) was officially announced, and the world’s first and only ROCK2 inhibitor Ilex® (besudinil mesylate tablets) approved for use in patients aged 12 years and above with chronic graft-versus-host disease (cGVHD) who have an inadequate response to glucocorticoid treatment was included in it . The adjusted new version of the medical insurance drug list will be officially implemented on January 1, 2025. 01. Chronic rejection after transplantation: the hidden “killer” and the dilemma of fibrosis cGVHD is the most common and serious complication after allogeneic hematopoietic stem cell transplantation, with an incidence of 30%-70%, and is the main cause of late non-relapse death two years after transplantation. The complexity of cGVHD lies in its invasion of multiple organs – from the skin to the lungs, from the ...
- Source: drugdu
- 98
- November 30, 2024

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