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The second new drug application for the combination of Xindilimumab and Fruquintinib has been accepted by the National Medical Products Administration

On June 5th, Xinda Biotechnology and Hehuang Pharmaceutical jointly announced that the new drug application for the combination therapy of Xindilimumab and Fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma patients who have previously failed treatment with a tyrosine kinase inhibitor has been accepted by the National Medical Products Administration (NMPA) of China. It is reported that the combination therapy of xindilimab and furosemide obtained conditional approval from NMPA in December 2024 for the treatment of advanced mismatch repair intact (pMMR) endometrial cancer patients who have failed previous systemic anti-tumor therapy and are not suitable for radical surgery or radiotherapy.
- Source: drugdu
- 52
- June 6, 2025
BCHT’s recombinant shingles vaccine clinical trial application approved

On the evening of June 4, BCHT, the company announced that it had received the “Notice of Approval for Drug Clinical Trial” for the recombinant herpes zoster vaccine (CHO cells) issued by the National Medical Products Administration, and the conclusion was that it agreed to conduct clinical trials for the prevention of herpes zoster. Herpes zoster is an acute infectious skin disease caused by the reactivation of the varicella-zoster virus (VZV) lurking in the body. The recombinant herpes zoster vaccine (CHO cells) approved for clinical use by Biotech is for adults aged 40 and above. After vaccination, it can stimulate the body to produce immunity against the varicella-zoster virus and is used to prevent herpes zoster. According to reports, the recombinant shingles vaccine (CHO cells) developed by the company is based on varicella-zoster virus glycoprotein E (gE protein) and is combined with the company’s independently developed innovative BK-02 adjuvant system. ...
- Source: drugdu
- 58
- June 6, 2025
Nine-valent HPV vaccine approved for marketing

On the evening of June 4, Wantai BioThe company announced that the nine-valent human papillomavirus (HPV) vaccine (Escherichia coli) (trade name: Xinkening 9) jointly developed by the company’s wholly-owned subsidiary Xiamen Wantai Canghai Biotechnology Co., Ltd. (“Wantai Vaccine”) and Xiamen University has been approved for marketing by the National Medical Products Administration. Previously, there was only one nine-valent HPV vaccine on the market worldwide, which was developed by MerckGardasil® 9. Wantai Vaccine, located in Xiamen Biomedicine Port, has worked closely with the National Infectious Disease Diagnostic Reagent and Vaccine Engineering Technology Research Center (NIDVD) of Xiamen University to build a mature industry-university-research model. The two parties have developed and launched a number of innovative vaccines, from hepatitis E vaccine, bivalent HPV vaccine, to the current nine-valent HPV vaccine (Xinkening 9). The launch of Xinkening 9 is the result of 18 years of collaborative innovation in “industry-university-research” between the two parties. ...
- Source: drugdu
- 50
- June 6, 2025
Breakthrough in Alzheimer’s disease diagnosis and treatment

Alzheimer’s disease (AD) is a disease that scares countless families. It has an insidious onset, continues to progress, and is irreversible. Brain lesions have already occurred quietly 15 to 20 years before obvious symptoms appear. Moving the diagnosis and intervention window forward is a key measure to reduce the incidence of AD. In decades of exploration, existing drugs have always been trapped in the cage of “delaying symptoms”. Now, with the maturity of diagnostic technology and the emergence of a new generation of drugs targeting beta-amyloid protein (Aβ), the academic community sees hope of “pressing the pause button on the disease”. In 2021, Aducanumab received accelerated approval from the FDA, becoming the first new drug approved by the FDA for AD, for the treatment of AD-related mild cognitive impairment (MCI) and mild AD. In 2023, the FDA approved Lecanemab for the treatment of early AD with mild cognitive impairment or ...
- Source: drugdu
- 37
- June 6, 2025
After Apixaban! Who will be the next anticoagulant king?

Among the bright stars of antithrombotic drugs, there are two dazzling stars that must be mentioned. One is aspirin, which is known as the “world’s best-selling drug”. The annual global consumption is still over 100 billion tablets, which can circle the earth 25 times if they are lined up; the other is apixaban, which has continuously broken through sales since its launch and firmly sits at the top of the small molecule drug sales list. As a key drug category in the field of cardiovascular disease treatment, antithrombotic drugs firmly occupy the top position both in the global drug sales rankings and in the actual needs of clinical treatment. They are an indispensable “weapon” for the treatment of cardiovascular diseases. Nowadays, as the global population aging trend becomes more and more obvious, the number of patients with cardiovascular diseases continues to rise. At the same time, the steady improvement of ...
- Source: drugdu
- 51
- June 6, 2025
【EXPERT Q&A】How to apply for medical device qualifications?

Drugdu.com expert’s response: The process of obtaining medical device qualifications involves multiple stages and stringent requirements, necessitating the preparation of corresponding materials and adherence to legal procedures based on the classification of medical devices (Class I, Class II, Class III) and the specific type of business operation (manufacturing or distribution). Below is a detailed explanation: I. Clarifying the Type of Qualification to Be Obtained Medical device qualifications are primarily categorized into manufacturing qualifications and distribution qualifications. These are further classified into Class I, Class II, and Class III based on the risk level of the medical devices. The requirements and procedures for obtaining qualifications vary across different categories. Class I Medical Devices: These pose a low risk and are subject to routine management. Generally, they only require filing and do not necessitate a license. Class II Medical Devices: These carry a moderate risk and require strict control and management. Distribution ...
- Source: drugdu
- 56
- June 6, 2025
4.1 billion US dollars! Thermo Fisher Scientific acquires Solventum’s purification and filtration business

On February 25th, Thermo Fisher Scientific (NYSE: TMO) announced that it has reached a final agreement with Solventum (NYSE: SOLV) to acquire Solventum’s purification and filtration business for approximately $4.1 billion in cash. The transaction is expected to be completed by the end of 2025. Affected by this transaction, the stock price of Thermo Fisher Scientific rose by 4%, and the stock price of Solventum rose by 10%. The transaction is expected to remain neutral on Solventum’s 2025 earnings per share (EPS) and is expected to bring in approximately $3.4 billion in net income, with Solventum’s plan primarily focused on reducing debt. This acquisition is expected to bring mid to high single digit organic growth to Thermo Fisher Scientific. By applying the PPI business system, the company will achieve strong profit expansion and significant synergies. In the first year after the completion of the transaction, it is expected that ...
- Source: drugdu
- 40
- June 5, 2025
COMPAMED

Organiser: COMPAMED Time：November 17–20, 2025 address：Messeplatz, Stockumer Kirchstraße 61, 40474 Düsseldorf, Germany Exhibition hall：Dusseldorf Exhibition Center Product range: Medical electronic instruments, ultrasonic instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, anesthesia and respiratory equipment, etc. Disposable medical supplies, dressings and hygiene materials, various surgical instruments, etc. Hospital ward, operating room, and emergency room equipment, hospital office equipment, laboratory equipment, etc. Medical and healthcare devices, home healthcare products, physiotherapy, orthopedic technologies, etc. Information and communication technologies, medical services, and publications, etc. Laboratory equipment and technologies, etc. About COMPAMED： The COMPAMED trade fair in Düsseldorf, Germany, is the world’s largest and most authoritative exhibition for the medical manufacturing industry. Since its inception in 1992, it has grown into a renowned comprehensive medical exhibition globally, recognized as the world’s premier event for hospitals and medical devices. With its unparalleled scale and influence, COMPAMED ...
- Source: drugdu
- 54
- June 5, 2025
Gloria Pharmaceuticals and Eisai China Pharmaceuticals Signed a Marketing Service Agreement for Methylcobalamin Injection

On the evening of June 3, Gloria Pharmaceutical(002437) issued an announcement stating that the company’s wholly-owned subsidiary Tianjin Gloria Boda Technology Co., Ltd. (hereinafter referred to as “Tianjin Boda”) and Eisai (China) Pharmaceuticals Co., Ltd. (hereinafter referred to as “Eisai China Pharmaceuticals”) signed a “Marketing Service Agreement” for “Methylcobalamin Injection” (trade name: Mecobalamin). The agreement stipulates that Eisai China Pharmaceuticals authorizes Tianjin Boda to exclusively promote methylcobalamin injection in mainland China (excluding the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan), and the authorization period is from June 1 to the expiration date of the agreement. Tianjin Boda is responsible for providing marketing services and other related services for the product in the above-mentioned regions. Gloria Pharmaceutical said that Tianjin Boda’s promotion of methylcobalamin injection will further enrich the company’s product pipeline and is expected to increase the company’s operating income and profits; in addition, it ...
- Source: drugdu
- 64
- June 4, 2025
Iopromide Injection Obtains Drug Registration Certificate

Starry Pharmaceutical announced on the evening of June 4 that its wholly-owned subsidiary Shanghai Sital recently received the “Drug Registration Certificate” for iopromide injection approved and issued by the National Drug Administration. This drug is indicated for use in diagnostic medication. It is used in blood vessels and body cavities. Computer X-ray tomography (CT) enhancement, arterial angiography and venography, arterial/venous digital subtraction angiography (DSA), especially suitable for cardiovascular angiography, intravenous urography, endoscopic retrograde pancreatocholangiopancreatography (ERCP), arthrography and other body cavity examinations, and cannot be used in the sheath. https://finance.eastmoney.com/a/202506043421771579.html
- Source: drugdu
- 64
- June 4, 2025

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