media – Page 9 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Zai Lab’s “core” innovative drug, the first of its kind, is on the verge of market launch

Small cell lung cancer (SCLC) is known as the “small lung killer” due to its high invasiveness and malignancy. Statistics show that about 80% of small cell lung cancer patients are diagnosed at an extensive stage (ES-SCLC), with an extremely poor prognosis. The median overall survival time is only 7 to 10 months, and the 2-year overall survival rate is only 10% to 20%. On April 18 , 2026 , Zai Lab officially announced that it will present the latest clinical data of its antibody-drug conjugate (ADC) zocilurtatug pelitecan (Zoci, formerly known as ZL-1310) targeting DLL3 at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The study showed that the drug achieved rapid and significant intracranial remission in previously treated patients with brain metastases from extensive-stage small cell lung cancer (ES-SCLC), and also demonstrated encouraging antitumor activity in patients with extrapulmonary neuroendocrine carcinoma (epNEC). picture According to publicly ...
- Source: drugdu
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- April 20, 2026
Eli Lilly’s Tadalafil® and Tadalafil® (mijicillinumab) have been officially launched in China, opening a new chapter in precision targeted therapy for inflammatory bowel disease.

April 18, 2026 – Eli Lilly China today announced the launch in China of its innovative drugs, Antrolet® (mijizumab injection) and Antrolet® ( mijizumab injection (subcutaneous injection)), for the treatment of inflammatory bowel disease (IBD). Antrolet® and Antrolet® (mijizumab), as inhibitors targeting the IL-23 p19 subunit, were approved by the National Medical Products Administration of China in February 2026 for the treatment of moderate to severe active ulcerative colitis (UC) and moderate to severe active Crohn’s disease (CD) in adults. These drugs have the potential to help IBD patients achieve early symptom improvement, mucosal healing, and stable control for up to 3-4 years , providing an innovative option for precision targeted therapy of IBD in China. Professor Chen Minhu, Chairman of the 11th Chinese Society of Gastroenterology, Head of the 12th Chinese Society of Inflammatory Bowel Disease Group, and Academic Leader and Chief Expert of Gastroenterology at the First Affiliated ...
- Source: drugdu
- 67
- April 20, 2026
【EXPERT Q&A】What requirements does the EU in vitro Diagnostic (IVDR) regulation have for product instructions?

Drugdu.com expert’s response: Core Requirements for Product Instructions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to Ensure Safety, Effectiveness, and Proper User Application I. Basic Information Requirements Manufacturer and Authorized Representative Information Must include the manufacturer’s full name, address, and the name and address of the EU authorized representative (if the manufacturer is located outside the EU). Example: If the manufacturer is based in China, the EU authorized representative’s contact details must be clearly indicated. Product Identification and Classification Must specify the product name, model number, unique device identifier (e.g., UDI code), and IVD product classification (Class A/B/C/D). Example: The front page of the instructions should clearly state: “Product Name: XX Blood Glucose Meter, Classification: Class B.” CE Marking and Compliance Statement Must include the CE mark and indicate compliance with IVDR requirements. Example: Display “CE 2017/746” prominently on the cover or a visible location, along ...
- Source: drugdu
- 87
- April 20, 2026
Why Did the “First Listed Company of China’s Biosimilars” Sell Its Only Innovative Drug for 450 Million? The Survival Rules for Biotechs Have Changed.

Late night on April 14, Bio-Thera Solutions issued an announcement stating that it would transfer Bevebatide Citrate Injection (Betanin), its Class 1 innovative drug that had been on the market for only 15 months, to Lepu Pharmaceutical, a subsidiary of Lepu Medical, for a total price of 450 million yuan. This “major new drug development” project, which once embodied the company’s ambition to expand into innovative drugs, has been wholly divested together with its marketing authorization, intellectual property rights, and commercialization interests. On April 14, prior to the announcement, Bio-Thera’s share price surged 5.96% in a single day, showing a clear signal of capital inflow. On the day following the announcement, the stock plunged 6.14%, with trading volume nearly doubling to a phased peak. Behind the sharp divergence between long and short positions lies the market’s re-evaluation of the nature of the deal: this is not a simple asset disposal, ...
- Source: drugdu
- 85
- April 17, 2026
After 12 years, Humanwell Healthcare Group has launched a groundbreaking oral painkiller designed to prevent abuse

According to the “China Pain Medicine Development Report (2020),” there are over 300 million chronic pain patients in China, and this number is rapidly increasing by 10 to 20 million annually. While pain doesn’t directly threaten life like other diseases, it can lead to a decline in quality of life and may contribute to suicide, premature death, Alzheimer’s disease, depression, and anxiety. Pain is mainly divided into acute pain and chronic pain. Chronic pain refers to pain that persists or recurs for more than three months, and its harmfulness far exceeds that of acute pain. On April 13, 2026 , according to the latest announcement on the official website of the Center for Drug Evaluation ( CDE ) of China, Humanwell Pharmaceutical US, Inc., a subsidiary of Humanwell Healthcare Group, received implied approval for its clinical trial application for hydrocodone bitartrate extended-release tablets, submitted under chemical drug registration category 5.2 ...
- Source: drugdu
- 87
- April 17, 2026
UCB’s “world’s first” innovative drug has just been approved for marketing in the European Union.

On April 15, 2026, UCB officially announced that the European Commission had approved KYGEVVI® ( deoxycytidine and deoxythymidine ) 2g/2g oral solution powder, making it the first and currently only approved drug in the EU for the treatment of genetically confirmed thymidine kinase 2 deficiency (TK2d), suitable for children and adults with symptom onset at age 12 years and under . This is the first and currently only approved treatment for TK2d.Publicly available information indicates that the main mechanism of action of KYGEVVI (deoxycytidine and deoxythymidine) is the integration of the pyrimidine nucleosides deoxycytidine (dC) and deoxythymidine (dT) into the mitochondrial DNA of skeletal muscle , thereby restoring mitochondrial DNA copy number and improving skeletal muscle function in TK2d patients. Deoxycytidine and deoxythymidine may utilize residual TK2 activity and cytoplasmic phosphorylation pathways (such as thymidine kinase 1 and deoxycytidine kinase) to increase the mitochondrial DNA precursors deoxycytidine triphosphate and deoxythymidine ...
- Source: drugdu
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- April 17, 2026
Dongyangguang Pharmaceutical’s protamine human insulin mixed injection (30R) pre-filled specification has been approved for marketing.

On April 9, 2026, Dongyangguang Pharmaceutical’s protamine human insulin mixed injection (30R) pre-filled specification officially received marketing approval from the National Medical Products Administration (NMPA) of China. This approval further enriches the company’s drug product pipeline in the field of diabetes and brings more and more convenient insulin medication options to diabetic patients in China. This product uses a classic premixed ratio of 30% soluble human insulin (short-acting) + 70% protamine human insulin (intermediate-acting). The dosage form and specifications are precisely matched to clinical needs, eliminating the need for frequent combination therapy, effectively simplifying treatment plans, helping patients achieve more stable blood glucose control, and improving their quality of life. ▶ Optimize insulin concentration and injection dosage scale: Precise blood sugar control It can match the individualized dosing needs of patients with different weights and blood glucose fluctuations, avoiding the inconvenience of large-dose injections and the dosage error problems when ...
- Source: drugdu
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- April 17, 2026
Johnson & Johnson’s gusejinumab receives dual approval for a new indication, bringing a blockbuster new drug to psoriatic arthritis treatment

On April 16, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its website that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson , had officially accepted two new marketing applications for gusejinumab injection (trade name: Tenoya®) for new indications (acceptance numbers: JXSS2600036 and JXSS2600037), both classified as Class 3.1 imported new drugs. This marks another important milestone for this world’s first IL-23 p19 targeted monoclonal antibody in China, signifying a comprehensive expansion of its indications and providing Chinese patients with autoimmune diseases with more comprehensive treatment options. picture From psoriasis to the entire autoimmune spectrum: the “Royal Path” of gasediumab. Gusekimumab is the world’s first approved monoclonal antibody targeting the IL-23 p19 subunit . By precisely blocking IL-23, a core “upstream” inflammatory factor in autoimmune diseases, it inhibits the inflammatory cascade response at its source and achieves long-term control of the disease. In ...
- Source: drugdu
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- April 17, 2026
Potential BIC! Amoytop Biotech Introduces New Drug for Chronic Hepatitis B

On April 16, Amoytop Bio announced that it had signed a Licensing Agreement with Aligos Therapeutics, Inc. According to the agreement, Amoytop Bio will obtain an exclusive, non-transferable intellectual property license from Aligos to develop, manufacture, and commercialize Pevifoscorvir sodium ( also known as ALG-000184) in the licensed territories (Mainland China, Hong Kong SAR, Macao SAR, and Taiwan) and in the licensed fields (treatment, prevention, or relief of human hepatitis B virus infection or human hepatitis B virus/hepatitis D virus co-infection) , and will have the right to sublicense as stipulated in the agreement. In return, Amoytop Biotech will pay Aligos an upfront payment of US$25 million upon the agreement’s effective date , and will also pay regulatory milestone fees (up to US$85 million ), sales milestone fees (up to US$335 million ), and royalties calculated as a single-digit percentage of net sales, based on the progress of clinical and ...
- Source: drugdu
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- April 17, 2026
Received $650 million RC148 down payment from AbbVie

On April 15th, Nanfang Finance News reported that Rongchang Biotechnology (09995.HK) issued a voluntary announcement stating that the company received a payment from AbbVie on April 15, 2026.The company has made an upfront payment of US$650 million for an exclusive licensing agreement for RC148. This agreement, effective March 10, 2026, grants AbbVie exclusive rights to develop, manufacture, and commercialize RC148 (the company’s proprietary PD-1/VEGF bispecific antibody drug) outside of Greater China. Under the agreement, the company is also entitled to up to US$4.95 billion in subsequent milestone payments, as well as tiered royalties from net sales outside of Greater China. This payment marks a significant step forward in the company’s international collaborations, will substantially enhance its cash reserves and R&D capabilities, and will facilitate faster global clinical development and pipeline value realization. https://finance.eastmoney.com/a/202604153706015296.html
- Source: drugdu
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- April 17, 2026

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