PharmaFocus Today – Page 78 – media

Application for registration and marketing authorization of quadrivalent influenza vaccine has been accepted

Chengda Bio announced in the evening that the application for registration and marketing authorization of the quadrivalent influenza virus split vaccine (referred to as “quadrivalent influenza vaccine”) developed by its wholly-owned subsidiary Chengda Bio (Benxi) Co., Ltd. in China has recently received the “Acceptance Notice” from the State Food and Drug Administration. https://finance.eastmoney.com/
- Source: drugdu
- 154
- January 30, 2025
Fosun Pharma’s drug registration application for salbutamol hydrochloride has been accepted

On January 24, Fosun Pharma (600196/02196) issued an announcement that the drug registration application for salbutamol hydrochloride nebulized inhalation solution of its holding subsidiary Fosun Pharma (Xuzhou) Co., Ltd. was recently accepted by the State Drug Administration. The drug is a chemical drug independently developed by the company, mainly used to treat or prevent bronchospasm caused by reversible airway obstructive diseases in adults and children over 6 years old. As of December 2024, the group’s cumulative R&D investment in the drug is approximately 4.54 million yuan. According to data provided by IQVIA, the sales of salbutamol hydrochloride nebulized inhalation solution in China in 2023 will be approximately 1.009 billion yuan. The announcement pointed out that the drug still needs to pass GMP compliance inspection and obtain drug registration approval before commercial production, so the acceptance of the drug registration application will not have a significant impact on the group’s current ...
- Source: drugdu
- 139
- January 30, 2025
encourage and support pharmaceutical operators to strengthen anti-monopoly compliance

On January 24, in order to effectively prevent and stop monopoly behavior in the pharmaceutical sector and safeguard consumer interests and social public interests, the State Council Anti-monopoly and Anti-unfair Competition Committee formulated and issued the “Anti-monopoly Guidelines for the Pharmaceutical Sector” (hereinafter referred to as the “Guidelines”). The “Guidelines” have 7 chapters and 55 articles. Aiming at the prominent monopoly problems in the pharmaceutical sector, they further refine the behavior, law enforcement principles and identification standards of monopoly behavior in the pharmaceutical sector. The “Guidelines” refine the behavior of monopoly agreements in the pharmaceutical sector. First, they list typical horizontal and vertical monopoly agreements in the pharmaceutical sector, and clarify the identification principles and ideas of anti-monopoly law enforcement agencies; Second, they summarize the behavior of new monopoly agreements in the pharmaceutical sector, and summarize the considerations for the application of the “Anti-monopoly Law” to reverse payment agreements; Third, ...
- Source: drugdu
- 185
- January 30, 2025
Johnson & Johnson’s revenue increased by 4.3% to US$88.821 billion last year, and pharmaceutical sales increased by 5.8%

Recently, Johnson & Johnson released its 2024 Q4 and full-year annual results. It was disclosed that the revenue in Q4 last year was US$22.52 billion, a year-on-year increase of 5.26%. Net profit was US$3.431 billion, a year-on-year decrease of 15.26%. In 2024, the company achieved revenue of US$88.821 billion, a year-on-year increase of 4.3%, and a year-on-year increase of 7% excluding the impact of exchange rates. The full-year net profit attributable to ordinary shareholders was US$14.066 billion, a year-on-year decrease of 59.99% compared with US$35.153 billion in the same period last year. Among them, global Johnson & Johnson’s innovative pharmaceutical sales were US$57 billion, a year-on-year increase of 5.8%. Global Johnson & Johnson Medical Technology sales were US$31.9 billion, a year-on-year increase of 4.8%. https://finance.sina.com.cn/
- Source: drugdu
- 150
- January 30, 2025
Without the consent of independent H-share shareholders, Henlius privatization terminated

On January 22, Fosun Pharma issued an evening announcement stating that the special resolution on the privatization of Henlius by its holding subsidiary Fosun New Drug through absorption merger was not approved at the H-share class shareholders’ meeting. Therefore, the absorption merger will not be implemented and Henlius will retain its H-share listing status. The announcement showed that the proposal was mainly opposed by small and medium-sized shareholders. At the interim shareholders’ meeting of Henlius, it was approved by more than two-thirds (including the number) of shareholders with voting rights who attended the meeting, but at the class shareholders’ meeting where only H-share shareholders had voting rights, the proportion of dissenting votes reached 19.25%, exceeding the 10% upper limit stipulated in the acquisition regulations. Fosun Pharma said that it regretted the failure of the Henlius privatization proposal and fully respected the decision of all shareholders. Fosun Pharma will continue to ...
- Source: drugdu
- 241
- January 27, 2025
Another ADC drug is approved for marketing

Recently, the FDA officially approved Datroway (datopotamab deruxtecan, Dato-DXd), an innovative antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of unresectable or metastatic hormone receptor (HR)-positive, HER2-negative adult breast cancer patients who have received endocrine therapy and chemotherapy. The key basis for the approval of Dato-DXd for breast cancer indications was the positive results of its Phase III clinical study TROPION-Breast01. In the TROPION-Breast01 study, Dato-DXd showed efficacy advantages. Compared with the standard therapy selected by the researchers, the drug successfully reduced the risk of disease progression or death in patients by 37%. This data means that in patients treated with Dato-DXd, the rate of disease deterioration has slowed significantly, giving patients more survival time and treatment opportunities. Specifically, progression-free survival (mPFS) was significantly extended from 4.9 months in the control group to 6.9 months in the trial group. In terms of safety assessment, a key concern ...
- Source: drugdu
- 171
- January 27, 2025
DR is the absolute king, and Wandong leads the industry in cutting-edge innovation

Recently, the 2024 DR equipment public bidding and procurement list was released, and domestic medical equipment won 10 of the 12 lists, marking the transformation of domestic substitution towards innovative applications. Wandong Medical has the highest market share and has dominated the list for more than ten consecutive years, deserving the title of DR King. In fact, the overall situation of DR equipment in 2024 is not optimistic. According to statistics from Zhongcheng Data Science, the overall market size of medical device bidding in China decreased by 21.1% year-on-year in 2024, with the DR equipment market also decreasing by 21.5%. The reasons for the decline are the multiple impacts of medical policies, technological innovations, and competitive trends. From the perspective of procurement trends, the market is divided into two levels: centralized procurement and high-level hospitals, which means higher requirements are placed on domestic medical equipment. It is worth mentioning that ...
- Source: drugdu
- 141
- January 26, 2025
drugs are replaced by new ones, and companies are competing in the market

On January 22, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Influenza Diagnosis and Treatment Plan (2025 Edition)” (hereinafter referred to as the “New Edition”). Compared with the “Influenza Diagnosis and Treatment Plan (2020 Edition)” (hereinafter referred to as the “2020 Edition”), the new version includes two anti-influenza virus drugs, Mabaloxavir and Favipiravir. Amantadine and rimantadine were eliminated due to drug resistance issues. At the same time, the new version of the plan clearly stated that it is not recommended to use antiviral drugs with the same mechanism of action in combination. Many pharmacists pointed out to the 21st Century Business Herald reporter that this move is aimed at optimizing the treatment effect and reducing unnecessary side effects. After the replacement of drugs, more and more companies have seen the development potential of the anti-influenza drug market. Competition in the oseltamivir market has ...
- Source: drugdu
- 170
- January 26, 2025
Under the vaccine price war, Kangtai Biological, which did not reduce prices, had a “turnaround” in its performance last year

On the evening of January 22, Kangtai Biological released its 2024 performance forecast. The performance forecast shows that in 2024, Kangtai Biological will achieve a net profit of 190 million to 270 million yuan, a year-on-year decrease of 77.94% to 68.65%. Last year, this figure was 861 million yuan. Kangtai Biological said that due to market competition, inventory reduction and other factors, the company’s operating income has declined to a certain extent compared with the same period last year; coupled with the increase in fixed asset depreciation expenses, asset impairment, and the termination of the 2023 equity incentive plan to accelerate the exercise of rights, the net profit in 2024 has decreased compared with the same period last year. On January 23, Jiemian News called Kangtai Biological’s secretary’s office. The staff responded that Kangtai Biological’s full range of products has not been reduced in price. Since the unit price of ...
- Source: drugdu
- 182
- January 26, 2025
China’s first monkeypox vaccine officially starts clinical trials

On January 21, the Phase I clinical research launch meeting of the MVA strain monkeypox live attenuated vaccine independently developed by Sinopharm Group China National Biotec Group Shanghai Institute of Biological Products was held at the Henan Provincial Infectious Disease Hospital (Zhengzhou Sixth People’s Hospital). The launch meeting was fully trained and discussed around the clinical trial plan, key points and difficulties of clinical site operations. On September 9, 2024, this monkeypox vaccine obtained the clinical trial notification issued by the State Food and Drug Administration. It is the first monkeypox vaccine approved for clinical trials in my country and is expected to play an important role in the prevention and control of diseases caused by monkeypox virus in my country. On January 22, the first batch of subjects in the Phase I clinical trial of the MVA strain monkeypox live attenuated vaccine were enrolled, marking that my country’s first ...
- Source: drugdu
- 234
- January 26, 2025

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