PharmaFocus Today – Page 47 – media

Trivalent influenza virus split vaccine approved for clinical trials

Nancai Intelligence reported on October 13th that Beike BioAnnouncement: Changchun Baike Biotechnology Co., Ltd. received the National Medical Products Administration’s announcement on the trivalent influenzaThe clinical trial approval notice for the viral split vaccine (BK-01 adjuvant) was issued. This vaccine is designed to prevent influenza caused by specific influenza virus types, specifically targeting people aged 60 and above, aiming to enhance the immune response in this age group. https://finance.eastmoney.com/a/202510133532452731.html
- Source: drugdu
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- October 14, 2025
Roche/Eli Lilly’s Alzheimer’s blood test gets approval, sparking anticipation among drug manufacturers

Roche announced on Monday that it and Eli LillyElecsys, a blood test for Alzheimer’s disease developed in collaboration with the two companies, has been approved for marketing by the U.S. Food and Drug Administration (FDA). (Source: Company website) The Elecsys test is reportedly suitable for patients aged 55 and above who have signs, symptoms or complaints of cognitive decline. It helps determine whether a patient has Alzheimer’s disease by measuring the level of phosphorylated Tau (pTau) 181 protein in plasma. Earlier in May, the FDA approved an Alzheimer’s disease blood test kit from Japan’s Fujirebio Diagnostics, which was the first product of its kind to be approved. The blood test could speed up the diagnosis of Alzheimer’s disease　　compared with traditional methods , including a lumbar puncture to collect cerebrospinal fluid and PET brain scans, which are expensive and may not be covered by health insurance. In a clinical trial involving ...
- Source: drugdu
- 146
- October 14, 2025
Lvzhu Biotech LZ901 Phase I clinical trial in the United States has been completed, with a low adverse reaction rate in the low-dose group.

　　On October 9, Lvzhu Biotech (02480) announced the successful completion of its Phase I clinical trial of LZ901 in the United States. The trial, which began in February 2023 and enrolled 66 healthy subjects aged 50 to 70, showed good safety and immunogenicity in both high- and low-dose groups of the LZ901 vaccine. 　　During the trial, only mild vaccine-related adverse reactions were reported in the low-dose group, with an incidence of 4.35%. Neither the high-dose group nor the placebo group experienced any such adverse reactions. LZ901 is a recombinant herpes zoster vaccine independently developed by the company, designed to prevent herpes zoster and its related complications in adults aged 40 and older. The vaccine’s Phase III clinical trial in China has achieved pre-specified objectives and anticipated results. 　　Currently, LZ901 biological productsThe license application has been accepted by the China National Medical Products Administration and is currently under evaluation. The Company reminds ...
- Source: drugdu
- 148
- October 13, 2025
Another rare disease drug has entered China. A similar product for systemic myasthenia gravis has passed the preliminary review catalog of this year’s national negotiation.

　　On October 11, multinational pharmaceutical company UCB announced that the China National Medical Products Administration (NMPA) has approved the marketing authorization of Zelukeblen sodium (trade name: Zobequel), which can be used in combination with conventional treatment drugs to treat adult patients with generalized myasthenia gravis (GMG) who are positive for anti-acetylcholine receptor (AChR) antibodies. 　　According to the information, Zelukeblen sodium is the world’s first and only new generation C5 complement inhibitor that can be injected subcutaneously, self-administered and has dual inhibitory effects. It can effectively block complement-mediated neuromuscular junction damage. Patients can complete the subcutaneous injection at home in only 5 to 8 seconds, reducing the burden of traveling to and from the hospital. 　　Generalized myasthenia gravis is a rare, chronic, and heterogeneous autoimmune disease with approximately 220,000 patients in China. Common pathogenic antibodies include AChR antibodies and muscle-specific receptor tyrosine kinase (MuSK) antibodies. Among them, AChR antibodies are the ...
- Source: drugdu
- 116
- October 13, 2025
Tianguangshi’s new drug marketing authorization application for MIL62 for the treatment of primary membranous nephropathy has been accepted

　　According to a report from People’s Finance on October 12th, Beijing Yizhuang WeChat account, Beijing Tianguangshi Biotechnology Co., Ltd. (hereinafter referred to as “Tianguangshi”), a company in Beijing Economic and Technological Development Zone (Beijing Yizhuang), recently announced that its independently developed innovative third-generation CD20 antibody MIL62 for the treatment of primary membranous nephropathy (PMN) has been accepted by the National Medical Products Administration. It is reported that this is the world’s first drug to be approved for the treatment of PMN. Its breakthrough not only provides a better treatment option for PMN, but also demonstrates China’s innovative drug development.Leading advantages in drug research and development and industrialization. https://finance.eastmoney.com/a/202510123531477277.html
- Source: drugdu
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- October 13, 2025
Its subsidiary’s core product, TROP2 ADC Lukangsatuzumab, has been approved by the National Medical Products Administration for a third indication.

　　Kelun PharmaceuticalThe announcement stated that Kelun Biotech’s controlled subsidiary, sac-TMT, an antibody-drug conjugate (ADC) targeting human trophoblast cell surface antigen 2 (TROP2), has been approved by the National Medical Products Administration for a third indication: the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation-positive disease who have progressed after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). sac-TMT is the first and only ADC in the world to date to demonstrate a significant overall survival (OS) benefit compared to platinum-based doublet chemotherapy and has been approved for advanced NSCLC that has progressed after prior TKI therapy (2L). https://finance.eastmoney.com/a/202510123531499855.html
- Source: drugdu
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- October 13, 2025
Fentanyl-stimulant overdose deaths surge among older adults

Overdose deaths in adults age 65 and older from fentanyl mixed with stimulants, such as cocaine and methamphetamines, have surged 9,000% in the past eight years, matching rates found among younger adults, according to research presented at the ANESTHESIOLOGY® 2025 annual meeting. The study is among the first to use Centers for Disease Control and Prevention (CDC) data to show that older adults, a group often overlooked in overdose research, are part of the broader rise in fentanyl-stimulant overdose deaths. Adults 65 years and older are especially vulnerable to overdoses because many live with chronic health conditions, take several medications and process drugs more slowly due to age. The opioid epidemic has unfolded in four waves, each characterized by a different type of opioid driving the increase in overdose deaths: prescription opioids in the 1990s; heroin starting in 2010; fentanyl starting in 2013; and a mix of fentanyl and stimulants ...
- Source: drugdu
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- October 13, 2025
Study reveals distinct links between depression subtypes and metabolic diseases

It is known that depression is linked to increased incidence of metabolic diseases; now scientists have discovered that different types of depression are linked to different cardiometabolic diseases. This work is presented at the ECNP Congress in Amsterdam. Over seven years, researchers tracked 5,794 adults, enrolled in the Netherlands Epidemiology of Obesity (NEO) Study, all of whom were free of diabetes and cardiovascular disease at the study’s start. At the start of the study each participant completed a comprehensive questionnaire to assess depressive symptoms. The team identified two distinct depressive profiles: one typified by “melancholic” symptoms (such as early morning awakening and reduced appetite), and another by “atypical/energy-related” symptoms (such as fatigue, increased sleep, and increased appetite). Around 8% of the participants developed a cardiometabolic condition during the follow-up period, but the type of condition they developed depended on the type of depression they had. Those with atypical/energy-related” symptoms were ...
- Source: drugdu
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- October 13, 2025
Sanofi achieves a major victory in Phase II clinical trials, challenging its dominance as the “number one nuclear medicine company”!

Sanofi announced that its targeted alpha nuclide therapy AlphaMedix achieved all primary efficacy endpoints in the Phase II clinical trial ALPHAMEDIX-02, demonstrating significant clinically meaningful efficacy in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement not only further confirms the potential of targeted α therapy to provide precise treatment for GEP-NETs, but also marks Sanofi’s challenge to Novartis, the “No. 1 nuclear medicine company.” 01 New Force Alpha Nuclide AlphaMedix is a targeted alpha therapy based on lead-212. It consists of a peptide complex that binds to somatostatin receptors and is coupled to a radionuclide. It serves as an in vivo generator of alpha particles. Due to their high energy and short range, alpha particles can precisely kill cancer cells while minimizing damage to surrounding healthy tissue, presenting potential therapeutic advantages. AlphaMedix wasn’t developed independently by Sanofi, but rather a key move in rapidly expanding its nuclear medicine portfolio ...
- Source: drugdu
- 181
- October 11, 2025
Paclitaxel for Injection Obtains Marketing Authorization in Multiple Countries

　　Shanghai Securities News China SecuritiesNetxun Huiyu Pharmaceutical announced on the evening of the 9th that its subsidiary Seacross Pharma (Europe) Ltd. recently received marketing authorization for the company’s product paclitaxel for injection (albumin-bound) approved and issued by the Netherlands Medicines Evaluation Committee, the Irish Health Products Regulatory Authority, the Finnish Medicines Agency, and the Swedish Medicines Agency. 　　Paclitaxel (albumin-bound) for injection is primarily indicated as monotherapy for the treatment of adult patients with metastatic breast cancer whose disease has not improved after first-line treatment of metastatic disease and for whom standard anthracycline-containing regimens are not appropriate; in combination with gemcitabine, it is indicated for the first treatment of adult patients with metastatic pancreatic adenocarcinoma; and in combination with carboplatin, it is indicated for the initial treatment of adult patients with non-small cell lung cancer who are not suitable for potentially curative surgery or radiotherapy. 　　Huiyu Pharmaceuticals stated that following its ...
- Source: drugdu
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- October 11, 2025

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