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Relevant flu drugs have not yet been organized for production and sales

On November 26th, Beijing University Pharmaceutical (000788.SZ) issued an announcement regarding abnormal stock trading. The company noticed that there might be a high incidence of influenza in some regions recently， which has drawn attention from the capital market. After self-examination， the company’s related influenza drugs have not yet been organized for production and sales. It is expected that for a considerable period of time in the future, this will not have any impact on the company’s operating performance. https://finance.eastmoney.com/a/202511263575631671.html
- Source: drugdu
- 70
- November 28, 2025
We have Obtained our First European Patent Certificate

China Securities News, Shanghai Stock Exchange: After the United States, Zhifei Biology has once again obtained a European patent certificate. The company announced on November 27 evening that its wholly-owned subsidiary, Beijing Zhifei Lvyu Biological Pharmaceutical Co., Ltd., recently received an invention patent certificate issued by the European Patent Office. The patent name is COMBINATION VACCINE AGAINST RESPIRATORY SYNCYTIAL VIRUS INFECTIONS AND IMMUNE RESPONSE INDUCTION METHOD THEREOF, which is a combination vaccine against respiratory syncytial virus infections and a method for inducing immune response. The patent number is EP4032548, and the estimated expiration date of the patent right is August 11, 2041. It is learned that this invention patent was obtained by Zhifei Lvyu in collaboration with Beijing Jiaotong University during the development of a respiratory syncytial virus (RSV) vaccine. The RSV vaccine developed through this collaborative development has already obtained patent authorization in China, Russia, and the United States. ...
- Source: drugdu
- 79
- November 28, 2025
The drug clinical trial approval notice has been issued for products such as SHR-9839 (injection) (sc)

South Finance Intelligence News, November 27th: Hengrui Pharma (stock code: 01276.HK) announced that recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. and its subsidiaries Suzhou Shendiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shendi Pharmaceutical Co., Ltd. have received the approval notice for clinical trials from the National Medical Products Administration regarding Injection HRS-7058 Capsule, HRS-7058 Tablets, SHR-9839(sc), Adabeleli Monoclonal Antibody Injection, Bevacizumab Injection, Injection SHR-A2102. These approvals allow for the conduct of clinical trials. Specifically, it is an II-phase clinical study of HRS-7058 combined with anti-tumor drugs in subjects with solid tumors. SHR-9839 is a company-developed humanized antibody drug, intended for the treatment of advanced solid tumors. As of now, the cumulative R&D investment for this project is approximately 72.31 million yuan. Adabeleli Monoclonal Antibody Injection is a company-developed humanized anti-PD-L1 monoclonal antibody. As of now, the cumulative R&D investment for this project is approximately 969 million yuan. ...
- Source: drugdu
- 88
- November 28, 2025
【EXPERT Q&A】What are the requirements of the General Safety and Performance Requirements (GSPR) under the EU medical Device MDR and IVDR regulations?

Drugdu.com expert’s response: The General Safety and Performance Requirements (GSPR) in the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) constitute the core framework for ensuring the safety and effectiveness of medical devices and in vitro diagnostic medical devices. The GSPR requirements permeate the entire lifecycle of medical devices, encompassing design, manufacturing, clinical evaluation, labeling, and post-market surveillance. The specific content is as follows: I. Chapter Division of GSPR The GSPR requirements are detailed in Annex I of the MDR and IVDR and are divided into three chapters: Chapter 1: General Requirements for Risk-Based Management Medical devices must operate in accordance with their intended design and must not endanger the health or safety of patients, users, or third parties. Risks must be minimized as much as possible, and the degree of reduction must not negatively impact the risk-benefit ratio. Manufacturers are required to establish, ...
- Source: drugdu
- 100
- November 28, 2025
Zhifei Biological Products Co., Ltd. obtains its first US patent certificate.

Zhifei BiologicalOn the evening of November 26, the company announced that its wholly-owned subsidiary, Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd., recently obtained an invention patent certificate issued by the United States Patent and Trademark Office. The patent, titled “Combined vaccine against human respiratory syncytial virus (RSV) infections and method thereof for inducing immune response,” is patent number US12,472,243B2, with an estimated expiration date of July 29, 2042. It is understood that the aforementioned invention patent was obtained by Zhifei Green Bamboo in collaboration with Beijing Jiaotong University during the development of a respiratory syncytial virus (RSV) vaccine. Zhifei Biological Products Co., Ltd. stated that it has obtained its first patent certificate in the United States, laying the foundation for its global expansion. This patent certificate will further enhance the company’s intellectual property rights.We will establish a protection system to fully leverage our independent intellectual property rights, promote technological innovation, ...
- Source: drugdu
- 92
- November 27, 2025
How can Li Lai be called a king?

Recently, Eli Lilly became the world’s first pharmaceutical company to surpass a trillion-dollar market capitalization. This milestone not only signifies recognition from the capital market but also symbolizes the pharmaceutical industry entering a new era of value. For a long time, the pharmaceutical industry has struggled to produce true “super giants” due to the fragmented nature of disease ranges and the limited market size. However, the emergence of GLP-1 drugs has completely changed this landscape. From diabetes to weight loss, and then to the treatment of diseases that benefit multiple organs, GLP-1 is redefining the boundaries of “blockbuster drugs.” 01 GLP-1 Revolution Looking back at the development of GLP-1, it was initially just an ordinary player in the field of diabetes treatment. Insulin has always held a dominant position in the diabetes market, and GLP-1 drugs, as a latecomer, initially had a relatively limited market size. The diabetes market is ...
- Source: drugdu
- 68
- November 27, 2025
Smegglutide clinical trial failed

On November 24, Novo Nordisk announced that semaglutide failed in two Phase III clinical trials (EVOKE and EVOKE+) for Alzheimer’s disease, failing to meet the primary efficacy endpoint. EVOKE and EVOKE+ are international, multicenter, randomized, double-blind, placebo-controlled phase III clinical trials that enrolled a total of 3,808 patients aged 55-85 with early symptomatic Alzheimer’s disease (1,855 for EVOKE and 1,953 for EVOKE+), including those in the mild cognitive impairment (MCI) and mild dementia stages. The trial used an oral semaglutide 14 mg once daily dosing regimen, with the target dose achieved through 8-week dose escalation (3 mg → 7 mg → 14 mg), for a total treatment duration of 156 weeks (104 weeks of primary treatment + 52 weeks of extension treatment). The primary endpoint of the trial was the change in the Clinical Dementia Rating Scale-Sum (CDR-SB) score relative to baseline at week 104. The CDR-SB scale assesses six ...
- Source: drugdu
- 71
- November 27, 2025
Walvax Biotech’s 13-valent Pneumococcal Conjugate Vaccine Granted Market Approval in Egypt

Beijing Business Today, Nov. 26 — Walvax Biotech announced that its subsidiary, Yuxi Walvax Biotech Co., Ltd., has received the “Biological Product Marketing Authorization” issued by the Egyptian Drug Authority (EDA) for its 13-valent Pneumococcal Polysaccharide Conjugate Vaccine, signifying that the vaccine has obtained marketing approval in Egypt. According to the announcement, the 13-valent Pneumococcal Conjugate Vaccine developed by Yuxi Walvax is primarily indicated for infants and children from 6 weeks up to 5 years of age (before their 6th birthday). It is designed to prevent infectious diseases caused by the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in the vaccine. This vaccine was initially approved for marketing in China back in 2020. Reference: https://finance.eastmoney.com/a/202511263575601059.html
- Source: drugdu
- 83
- November 27, 2025
Why Is Flu Vaccination So Hard to Promote?

During each flu season, the rapid surge in influenza cases within a short period can place tremendous pressure on healthcare facilities. Receiving the flu vaccination is regarded as the “first line of defense” against influenza, significantly reducing the risk of infection and severe complications among recipients. However, the influenza vaccination rate in China has long remained at an unsatisfactory level, lingering in the single digits. Compared to the market for influenza treatment drugs, sales in the flu vaccine market have consistently underperformed. Flu vaccine sales are outsold by influenza treatment drugs A Yicai reporter compiled the 2024 sales data of influenza vaccine companies listed on the A-share and Hong Kong stock markets. The main A-share influenza vaccine enterprises include Hualan Vaccine (301207.SZ), GDK Bio (688670.SH), and BCHT (688276.SH). The primary Hong Kong-listed influenza vaccine company is Zhonghui Biotech (02627.HK). From 2021 to 2024, Hualan Vaccine consistently maintained the leading position ...
- Source: drugdu
- 109
- November 27, 2025
Additional clinical trial data for pediatric patients is needed. Tian Tan Biologics has withdrawn its application for the market release of a hemophilia treatment drug.

More than 10 months after its submission, Tian Tan Biologics (SH600161, stock price 17.61 yuan, market capitalization 34.822 billion yuan) withdrew its application for listing of a hemophilia drug that cost 266 million yuan to develop. On the evening of November 19th, this leading domestic blood product company released a statement, stating that its subordinate enterprise, Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Chengdu Rongsheng), withdrew the drug registration application for “Recombinant Human Coagulation Factor VIIa for Injection”. The reason was that according to the review opinions of the CDE (National Medical Products Administration Drug Evaluation Center), supplementary information was required. It became the first domestically produced recombinant human coagulation factor VIIa biological product to be approved for market launch in China. However, from the indication perspective, Anqixin’s application scope is much smaller than Nuoqi. The products under Tian Tan Biotechnology are more similar to Nokir. On December ...
- Source: drugdu
- 73
- November 27, 2025

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