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Guang Sheng Tang-Neraprazole initiated a Phase I clinical trial in China for liver injury and chronic hepatitis B.

On April 23, 2026, Guang Sheng Tang initiated a Phase I clinical trial in China for nerecvir (an HBcAg inhibitor) for the indication of liver injury and chronic hepatitis B. The trial (CTR20261605), titled “Pharmacokinetics and Safety Study of GST-HG141 Tablets in Participants with Impaired and Normal Liver Function,” plans to enroll 24 subjects. The investigational drug in this clinical trial is Neratrovir. The primary endpoints include the following pharmacokinetic parameters: Cmax (maximum plasma concentration), Tmax (time to peak concentration), t1 /2 (half-life), AUC0 -t (area under the curve from dosing to the last detection time), AUC0 -∞ (area under the curve from dosing to infinity), CL/F (apparent clearance), Vz/F (apparent volume of distribution), and plasma protein binding rate. https://bydrug.pharmcube.com/news/detail/794753dd6168e510cf7df98863df6eea
- Source: drugdu
- 48
- April 24, 2026
the global setbacks of FIC

Once a global FIC drug, it has suffered a major setback in the domestic market. According to the NMPA website, Daiichi Sankyo’s Pexidartinib received a “drug notification.” While the specific reason has not been disclosed, this means the drug has not been approved. Of course, this result is not entirely unexpected. After all, while pexidartinib does offer improved patient benefits, its risks cannot be ignored; it had previously been rejected by the EMA in Europe. Meanwhile, in China, pimitinib, with its superior efficacy and safety profile, has already been approved for marketing. To some extent, the failure of Pexidartinib is not just a failure of a single drug, but also reflects a change in the times. With the continuous rise of domestically developed innovative drugs, offering patients better options, domestic regulatory authorities are imposing increasingly higher requirements on drug review and approval. This is especially true for drugs treating non-fatal ...
- Source: drugdu
- 46
- April 24, 2026
Yingpai Pharmaceutical is about to go public.

On April 20, Yingpai Pharmaceutical’s IPO application on the Hong Kong Stock Exchange passed the hearing, meaning it is about to be listed. Founded in 2009, Imbisoft is dedicated to advancing precision oncology therapies based on synthetic lethal mechanisms globally. Imbisoft has built a robust pipeline in the field of synthetic lethality, and is one of only three companies worldwide to simultaneously possess commercially viable PARP1/2 inhibitors and next-generation PARP1 inhibitors in clinical trials. The pipeline for future research and development includes ATR inhibitors, WEE1 inhibitors, SHX9 inhibitors, brain-penetrating PARP1 inhibitors, ATM inhibitors, USP1 inhibitors, CHK1/2 inhibitors, and more. Yingpai Pharmaceutical’s R&D expenditures in 2024 and 2025 were RMB 195 million and RMB 184 million, respectively. As of the end of 2025, Yingpai Pharmaceutical had RMB 259 million in cash on hand. In conclusion , regarding business development (BD) collaborations, Innovent Biologics licensed the overseas rights to its PARP1 inhibitors ...
- Source: drugdu
- 43
- April 24, 2026
Breaking News! The world’s leading medical device company completes a major acquisition.

Recently, Medtronic, the world’s leading medical device company, announced the completion of its acquisition of CathWorks, significantly increasing its investment in the cardiovascular field. Image source: Medtronic official website 01 Cardiovascular track Continue to increase investment CathWorks, founded in 2013, has focused on developing cardiovascular imaging and treatment solutions based on computer vision and artificial intelligence technologies , aiming to provide objective data for percutaneous coronary intervention (PCI) decisions. It’s worth noting that Medtronic’s acquisition of CathWorks was not accidental, but rather the result of nearly eight years of gradual integration. As early as 2018, Medtronic already held a minority stake in CathWorks; in 2022, the relationship between the two parties was further upgraded to a strategic partnership, at which time Medtronic invested approximately US$75 million to jointly promote CathWorks’ core product, the FFRangio system, in the US, European, and Japanese markets . On February 3, 2026, Medtronic officially announced ...
- Source: drugdu
- 39
- April 24, 2026
Maiwei Biotech adds another potential drug

Currently, 12 TCE drugs have been approved for marketing globally, 9 of which are used to treat hematological malignancies, targeting tumor antigens such as CD20, BCMA, CD19, and GPRC5D. Meanwhile, a number of emerging targets are beginning to appear in the pipeline. Recently, Maiwei Bio announced that the NMPA has accepted its clinical trial application for its independently developed 6MW5311, which is intended to be developed for hematological malignancies (acute myeloid leukemia, chronic myelomonocytic leukemia and multiple myeloma). It is worth noting that 6MW5311 is the world’s first innovative bispecific antibody targeting LILRB4/CD3 TCE to be submitted for clinical trials. Its application for clinical trials in the United States is already in the pre-IND stage, and the company plans to formally submit the application to the FDA in the second quarter of 2026. 01 Differentiation targeting the “drug shortage” market LILRB4 (a member of the leukocyte immunoglobulin-like receptor subfamily B) ...
- Source: drugdu
- 38
- April 24, 2026
The Hidden Champion in the Chronic Disease Market

Recently, Kanghong Pharmaceutical released its 2025 annual report, showing annual revenue of 4.585 billion yuan, a year-on-year increase of 2.98%, and net cash flow from operating activities of 1.504 billion yuan, a year-on-year increase of 6.50%. This marks the fifth consecutive year of steady growth. In an industry context where innovative drugs face a high risk of failure and centralized procurement has become the norm, where does Kanghong Pharmaceutical’s growth resilience come from? The answer lies not only in its impressive surge in biopharmaceuticals, but also in its long-term, meticulous cultivation of traditional Chinese medicine. Data shows that the company’s traditional Chinese medicine segment achieved revenue of 1.496 billion yuan, a year-on-year increase of 5.80% , leading the overall growth rate. While the market chases one hot biopharmaceutical trend after another, it has quietly built an insurmountable moat in the field of traditional Chinese medicine. Focusing on the golden track ...
- Source: drugdu
- 37
- April 24, 2026
【EXPERT Q&A】What documents are required for CE certification?

Drugdu.com expert’s response: CE Certification: Mandatory Safety Certification for Products Entering the EU Market CE certification serves as a mandatory safety certification for products to enter the European Union market, and the preparation of relevant documentation must strictly adhere to EU directives, such as the Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), Medical Device Directive (MDD), etc. I. Core Documents (General Requirements) Technical File Product Description: Include the name, model number, specifications, intended use, and functional descriptions (covering all variant models). Design Drawings: General assembly drawings, component drawings, circuit diagrams (including electrical schematic diagrams and wiring diagrams), and mechanical drawings (if applicable). Risk Assessment Report: Identify risks throughout the product’s lifecycle (e.g., electrical safety, mechanical hazards, biocompatibility) in accordance with ISO 14971 and describe risk control measures. List of Conformity Standards: Clearly specify applicable EU directives (e.g., LVD 2014/35/EU, EMC 2014/30/EU) and harmonized standards (e.g., EN 60601-1, the general ...
- Source: drugdu
- 47
- April 24, 2026
GSK announces that belantamab mafodotin has been approved in China.

On April 20, 2026 , GlaxoSmithKline (GSK) announced that its drug Blenrep (generic name: belantamab mafodotin) had been approved by the National Medical Products Administration (NMPA) of China. The approved indication is for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) in combination with bortezomib and dexamethasone (BVd regimen) who have received at least one prior line of therapy . This approval was based on the priority review process, and the combination therapy had previously been granted Breakthrough Therapy designation in China, both because it is expected to provide significant improvements over existing therapies. Core approval information and key data Approved regimen : Blenrep + bortezomib + dexamethasone (BVd). Target patients : Adult patients with relapsed or refractory multiple myeloma who have previously received at least one first-line treatment. Key advantages : 1) It is the first and only approved anti-BCMA (B-cell maturation antigen) therapy in ...
- Source: drugdu
- 60
- April 23, 2026
Eli Lilly invests a staggering 47.7 billion! Betting on next-generation cancer drugs

On April 20, Eli Lilly announced a major acquisition: it will acquire biotechnology company Kelonia Therapeutics for a total price of up to $7 billion (approximately RMB 47.7 billion) . At the heart of this acquisition is Kelonia’s disruptive in vivo CAR-T technology platform, iGPS . Traditional CAR-T therapy, hailed as a revolution in cancer treatment, is extremely complex and expensive: it requires extracting T cells from the patient, genetically modifying and expanding them in an external factory, and finally reinfusing them into the patient. This process takes weeks and is costly, severely limiting its accessibility. Kelonia’s technology bypasses this cumbersome process. At its core is a specially modified lentiviral vector that, through intravenous infusion, directly transforms ordinary T cells into CAR-T cells within the patient’s body, enabling them to precisely identify and attack cancer cells. This in vivo manufacturing model theoretically transforms CAR-T therapy from a highly personalized, custom-made ...
- Source: drugdu
- 55
- April 23, 2026
Vaccine Leader Welcomes Post-85s New Helmsman

On April 21, Hualan Vaccine issued a major announcement: Ms. An Wenjue, aged 37, was formally elected Chairwoman of the company’s third board of directors and appointed its legal representative. This personnel change is far more than a simple generational shift. It marks the official entry of this billion-market-cap vaccine industry leader into a new development phase helmed by a post 85s leader. As the daughter of An Kang, founder of the Hualan Group, An Wenjue’s succession represents both the natural continuation of family business inheritance and a critical step for Hualan Vaccine to pursue high-quality development and breakthroughs amid profound restructuring in the vaccine industry. This transition not only shapes the future of a leading enterprise but also reflects the broader trend and thinking around “second-generation succession” in the pharmaceutical sector. From Finance to Overall Leadership An Wenjue’s path to the top has been built on more than a ...
- Source: drugdu
- 49
- April 23, 2026

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