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PCV24 approved for clinical trials.

CanSino Biologics Inc. (hereinafter referred to as “CanSino Biologics”) announced today that its independently developed 24 -valent pneumococcal polysaccharide conjugate vaccine ( CRM197/ tetanus toxoid, hereinafter referred to as “PCV24” ) has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, agreeing to conduct clinical trials for the product. This marks the continued expansion of CanSino Biologics’ R&D pipeline in the field of pneumococcal conjugate vaccines, laying the foundation for further enriching its portfolio of high-valent pneumococcal vaccine products. Pneumococcal disease is one of the most serious public health problems worldwide . <sup>1</sup> World Health Organization (WHO) data shows that approximately 1.6 million people die globally each year from pneumococcal-related diseases, with infants and the elderly being the most affected groups . <sup>2 </sup> Streptococcus pneumoniae is a major pathogen causing serious diseases such as pneumonia, meningitis, and bacteremia in children, and is also a ...
- Source: drugdu
- 61
- January 6, 2026
Rongchang Bio’s Vidicetumab makes its fourth attempt at “breakthrough therapy,” prompting a reassessment of its value as a first-line treatment for HER2-positive gastric cancer

Recently, the CDE (Center for Drug Evaluation) website announced that the new indication for Vidistovimab injection in combination with trastuzumab and toripalimab as first-line treatment of HER2-high expressing advanced gastric/gastroesophageal junction adenocarcinoma is proposed for inclusion in the Breakthrough Therapy designation. If successfully approved, this will be the fourth Breakthrough Therapy designation received by this drug since its launch in 2021, setting a new record for regulatory approval of domestically produced ADC (anti-adrenergic cellular carcinoma) drugs. HER2 is an important therapeutic target for gastric cancer, accounting for approximately 12%-23% of all gastric cancers. If low-to-medium HER2 expression is included, then about 40%-45% of gastric cancer patients express HER2. These tumors are more aggressive and prone to recurrence and metastasis. Vidicetumab (trade name: Aidixi® ) is China’s first original ADC drug developed by Rongchang Biotechnology. Targeting the HER2 protein on the tumor surface, it can precisely identify and kill tumor cells. ...
- Source: drugdu
- 60
- January 6, 2026
When BTK inhibitors break through “cross-border” boundaries

BTK inhibitors are transforming from a “darling” of hematological malignancies into a “rising star” in the autoimmune field. This star target, with its central role in B-cell and myeloid cell signaling pathways, has successfully broken down the boundaries of the therapeutic field, “crossing over” from oncology to the autoimmune field . 01 Star Target BTK is a non-receptor tyrosine kinase that plays a central role in signal transduction of various cell surface receptors (mainly BCR). After B cell carcinogenesis, BTK becomes abnormally active. Activation of the BTK signaling pathway sends a signal to initiate the growth of B cell malignant tumor cells and plays an important role in growth and migration. BTK inhibitors (BTKi) act on the BCR signaling pathway, specifically binding to BTK to inhibit BTK autophosphorylation, prevent BTK activation, thereby blocking signal transduction and inducing apoptosis, thus controlling the development of B-cell tumors. Since the first covalent BTKi ...
- Source: drugdu
- 59
- January 6, 2026
MSD’s Breakthrough Innovative Drug Sotatercept for Injection Approved in China

MSD’s Breakthrough Drug Sotatercept (Winrevair®) Approved in China for Pulmonary Arterial Hypertension Shanghai Securities News (Reporter: Zhang Xue) — On January 5, MSD (known as Merck & Co. in the U.S. and Canada) announced that Winrevair® (Sotatercept for Injection), the world’s first and currently only breakthrough activin signaling inhibitor (ASI) therapy, has been approved by China’s National Medical Products Administration (NMPA). The drug is indicated for the treatment of adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1) who have WHO Functional Class (FC) II-III symptoms, aiming to improve exercise capacity and WHO functional class. PAH is a relatively rare and difficult-to-treat cardiovascular disease. Research suggests that the median survival period for patients with idiopathic PAH who do not receive targeted treatment is only 2.8 years after the onset of symptoms. As the disease progresses, patients face increasing limitations in physical activity; in severe cases, they may become unable to ...
- Source: drugdu
- 53
- January 6, 2026
Subsidiary’s Class 1 Innovative Chemical Drug HW221043 Tablets Approved for Clinical Trials

On January 5, ST Humanwell (600079) announced that its wholly-owned subsidiary, Hubei Bio-pharmaceutical Industrial Technology Research Institute Co., Ltd., has received approval to conduct clinical trials for HW221043 Tablets in patients with advanced solid tumors. HW221043 Tablets are classified as a Class 1 chemical drug intended for the treatment of advanced solid tumors. As a New Molecular Entity (NME) independently developed by the company, there are currently no similar drugs approved for marketing either domestically or internationally. To date, the cumulative R&D investment for HW221043 Tablets totals approximately 24 million RMB. In the first three quarters of 2025, ST Humanwell reported a revenue of 17.883 billion RMB and a net profit attributable to the parent company of 1.689 billion RMB. https://finance.eastmoney.com/a/202601053608841348.html
- Source: drugdu
- 50
- January 6, 2026
Expomed Eurasia

Organiser：REED TUPAY Time：April 16 – 18, 2026 Address：Cumhuriyet, Kardeş Sk. 1b, 34522 Büyükçekmece/İstanbul, Turkey Exhibition hall：TUYAP Exhibition Center Product range: Expomed: Medical technology/electronic medical products, equipment, and systems; biomedical products, equipment, and apparatus; diagnostic and imaging products, equipment, and systems; medical communication products, equipment, and systems; portable physical therapy and orthopedic products, equipment, and systems; surgical products, equipment, and systems; hospital and facility management services, products, installations, and equipment; medical room facilities and systems; hygiene and disinfection products, equipment, and apparatus; hospitals and health clinics; rehabilitation devices and equipment; related institutions and media Labtech: Medical analytical instruments and accessory equipment, chromatographic instruments and accessory equipment, laboratory extraction and filtration equipment, electrophoresis equipment and accessories, spectrophotometers, photometers and accessories, microscopes and accessory equipment, monitoring and measuring instruments, laboratory-specific cleaning and drying instruments/quality control equipment, medical sensing equipment, laboratory benches, laboratory modules, and other laboratory-related products About Expomed Eurasia ： Expomed Eurasia, ...
- Source: drugdu
- 65
- January 6, 2026
Eharmony Pharma Secures Nearly RMB 100 Million in Series B Funding to Develop Innovative Inhalable Weight-Loss Drugs

Recently, Eharmony Pharma announced the completion of its nearly RMB 100 million Series B financing round. This round was led by Beijing Medical and Health Industry Investment Fund, with participation from follow-on investors including Sanze Ventures and other institutions. The funds will be focused on three core strategic areas: advancing clinical development of key pipeline candidates, building a world-leading peptide inhalable delivery platform, and accelerating the global layout of innovative products. These initiatives will comprehensively consolidate the company’s end-to-end competitive advantages in the field of dry powder inhaler (DPI) drug delivery. Eharmony Pharma is a high-tech enterprise specialized in “drug-device combination dry powder inhaler (DPI) delivery innovation”, integrating research and development (R&D), manufacturing, and sales. The company primarily focuses on the development of dry powder inhalable formulations for respiratory and cardio-cerebrovascular diseases, having established an integrated closed-loop system covering laboratory technology, industrial-scale production, and commercialization. The successful closing of ...
- Source: drugdu
- 68
- January 5, 2026
The first domestically produced targeted drug for thyroid eye disease has been launched, with a price reduction of up to 60%.

The new version of the National Medical Insurance Drug Catalog will officially take effect on January 1, 2026. It is understood that Innovent Biologics’ innovative drug for the treatment of thyroid eye disease…The first prescription for Tetumumab N01 injection (Symbim) after it was included in medical insurance was issued nationwide by the team of Academician Fan Xianqun from the Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine. This drug is the first domestically produced targeted therapy for thyroid eye disease in 70 years. Thyroid eye disease is a common orbital disease affecting over 4 million people in China, often leading to protruding eyeballs and vision impairment. Previously, effective treatments were limited. Tetumumab is China’s first and only targeted therapy covered by medical insurance that can reverse protruding eyeballs, achieving a response rate of 85.8% and an overall ocular efficacy of 94.2%. With inclusion in medical insurance, ...
- Source: drugdu
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- January 5, 2026
First shipment of Zantinib (Saint Hertu®) arrives! A new era of precision-targeted therapy for HER2-mutant advanced NSCLC begins.

On January 4th, the first batch of Zonaitinib tablets (Shenghetu®), jointly promoted by Boehringer Ingelheim and China Biopharmaceutical (1177.HK), arrived in China and will be put into clinical use in Guangzhou, Shanghai, and other regions as soon as possible. As the world’s first and currently only oral targeted drug approved in China for the treatment of HER2-mutant advanced non-small cell lung cancer (NSCLC), Zonaitinib provides patients with a highly effective, safe, targeted, and oral new treatment option, officially ushering in a new era of highly selective oral targeted therapy for the treatment of HER2-mutant advanced NSCLC in China. In August 2025, Zonaitinib received formal approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy. Notably, Zonaitinib took only one ...
- Source: drugdu
- 70
- January 5, 2026
Clinical trial application for new drug targeting integrin β6 ADC approved

Kelun Pharmaceutical (002422.SZ) announced that its subsidiary, Kelun Biotech , has received approval from the Center for Drug Evaluation of the National Medical Products Administration of China for its clinical trial application for SKB105 (also known as CR-003), an antibody-drug conjugate targeting integrin β6 (ITGB6) , for the treatment of advanced solid tumors.In addition, in December 2025, Kelun Biotech and Crescent Biopharma entered into a strategic collaboration on SKB105/CR-003 and SKB118 (PD-1 x VEGF bispecific antibody, also known as CR-001). Kelun Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside Greater China. Crescent granted Kelun Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. Kelun Biotech plans to submit an IND application for SKB118/CR-001 in the near future. SKB105 is a differentiated ADC targeting ITGB6, using a topoisomerase 1 inhibitor as its payload. ...
- Source: drugdu
- 65
- January 5, 2026

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