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

Its drug marketing application for injectable iza-bren has been accepted

On January 20, Baili Tianheng (688506.SH) announced that it had received an Acceptance Notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The NDA for its independently developed, first-in-class, new-concept EGFR×HER3 bispecific antibody ADC (iza-bren), the only one to enter Phase III clinical trials, has been formally accepted. Iza-bren, used to treat recurrent or metastatic esophageal squamous cell carcinoma, has also been included in the priority review list by the CDE. This drug is the world’s first EGFR×HER3 bispecific antibody ADC to have its NDA accepted. Iza-bren is currently undergoing more than 40 clinical trials in China and the United States targeting various tumor types. To date, iza-bren has 7 indications included in the CDE’s Breakthrough Therapy List, 2 indications included in the CDE’s Priority Review List, and 1 indication included in the U.S. Food and Drug Administration’s Breakthrough Therapy List. https://finance.eastmoney.com/a/202601203624810110.html
- Source: drugdu
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- January 21, 2026
Kain Technology withdrew a drug registration application, resulting in a profit reduction of 111 million yuan in 2025

On January 20, 2026, KAIN Technology, a company listed on the Science and Technology Innovation Board,(688687.SH) disclosed that it has withdrawn its drug registration application for Peicheng Interferon α-2 Injection (with the addition of hepatitis B indication). Peicheng Interferon α-2 Injection is a marketed drug indicated for the treatment of chronic hepatitis C (HCV) in adults. It obtained drug registration approval and a new drug certificate in 2018. In September 2024, KAIYIN Technology submitted an application for a new indication for the drug. The application withdrawn this time pertains to this newly submitted indication. According to the latest review recommendations from the National Medical Products Administration ( NMPA) , and after careful consideration, the company has decided to voluntarily withdraw its drug registration application. It will further supplement its clinical case studies in accordance with the relevant requirements of the NMPA and resubmit the registration application as appropriate. Kaiyin Technology ...
- Source: drugdu
- 56
- January 21, 2026
Received Notice of Approval for Drug Clinical Trial

Hengrui Pharma announced on January 20, 2026, that the company and its subsidiaries, Suzhou Shengdia Biopharmaceutical Co., Ltd. and Shanghai Hengrui Pharmaceutical Co., Ltd., have received the “Notice of Approval for Drug Clinical Trial” issued by the National Medical Products Administration (NMPA) for SHR-9839 for Injection (sc) and HRS-4642 Injection. Clinical trials for these drugs will commence in the near future. Additionally, its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the “Notice of Approval for Drug Clinical Trial” from the NMPA for HRS-2141 Tablets (I) and (II), and will also begin clinical trials shortly. https://finance.eastmoney.com/a/202601203624765352.html
- Source: drugdu
- 67
- January 21, 2026
Breaking news! AstraZeneca to be delisted from Nasdaq.

On January 20 , Reuters reported that AstraZeneca announced a major restructuring of its listing : the company will delist its American Depositary Receipts ( ADS ) and debt securities from Nasdaq and directly list its common stock and debt products on the New York Stock Exchange. The changes will take effect after the close of trading on January 30 , 2026 . It is understood that AstraZeneca ‘s common stock and debt securities are expected to begin trading on the NYSE on February 2 , and will continue to use the stock code “AZN” to ensure trading continuity for investors. This restructuring of the listing structure is a core component of the unified listing plan approved by AstraZeneca shareholders. Following the implementation of the unified structure, AstraZeneca will shift from trading ADSs (representing its common stock at a 2-to-1 ratio) to directly listing its $0.25 common stock, thereby simplifying ...
- Source: drugdu
- 68
- January 21, 2026
XinYue Bio Secures Tens of Millions in Series A+ Follow-on Funding to Advance DEL+AI-Powered Drug Discovery

Xinyue Bio closes multi-million RMB Series A+ round with follow-on from XtalPi (2228.HK). This latest funding, secured within six months of XtalPi’s initial investment, underscores strong investor confidence. The funds will drive the R&D of Xinyue Bio’s “DEL+AI” platform and accelerate the clinical development of its pipeline, aiming to boost efficiency and success rates in early drug discovery. Synergy in Action: Building a New Engine for Drug R&D Xinyue Bio specializes in the advanced development and application of DNA-Encoded Library (DEL) technology, dedicated to empowering and advancing innovative drug discovery. The company’s proprietary DEL live-cell screening platform enables effective screening of membrane proteins that are difficult to express and purify. This not only expands the range of druggable targets accessible to DEL technology but also represents a screening approach that more closely mimics physiological conditions. As a pioneer in AI-driven drug discovery, XtalPi leverages a high-precision drug design platform that ...
- Source: drugdu
- 49
- January 21, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Brazil?

Drugdu.com expert’s response: I. ANVISA Certification (Core Certification) The Brazilian National Health Surveillance Agency (ANVISA) is the primary regulatory authority for the export of active pharmaceutical ingredients (APIs) to Brazil. Its certification requirements include: 1. Registration Application Foreign companies must submit applications through a Brazilian-based registered agent (a qualified company or professional) responsible for document preparation, submission, and communication with ANVISA. Application documents must include: Drug composition, dosage form, dosage, pharmacological mechanism, manufacturing process, and quality management system (GMP). Clinical trial data (for new drugs) or bioequivalence study data (for generic drugs). Pharmacological and toxicological research data, stability data, etc. 2. Labeling and Packaging Insert Labels must be in Portuguese and include the drug name, ingredients, dosage form, indications, usage instructions, dosage, and adverse reactions. The packaging insert must provide detailed usage instructions, including indications, dosage, adverse reactions, contraindications, etc. 3. Review and Approval ANVISA reviews the drug’s safety, efficacy, and manufacturing compliance (GMP). ...
- Source: drugdu
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- January 21, 2026
20-Valent Pneumococcal Vaccine Approved for Clinical Trials

On January 19, AIM Vaccine (06660.HK) issued an announcement stating that its self-developed 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA), officially granting approval for clinical trials. The vaccine is an optimized upgrade of the 13-valent pneumococcal conjugate vaccine (PCV13), adding 7 new serotypes for a total of 20 major prevalent serotypes. It is designed to prevent invasive diseases caused by these serotypes, such as pneumonia, meningitis, and bacteremia. https://finance.eastmoney.com/a/202601193623487020.html
- Source: drugdu
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- January 20, 2026
ADC205 Tablets Received Approval for Drug Clinical Trial

Jiangsu Aidea Pharma Announcement: The company has received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration (NMPA) on January 18, 2026. The notice approves clinical trials for the company’s investigational Class 2.3 modified new drug, Dolutegravir/Lamivudine/Tenofovir Tablets (ADC205), which is dedicated to the field of anti-HIV/AIDS. https://finance.eastmoney.com/a/202601193623367035.html
- Source: drugdu
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- January 20, 2026
Sifang Optoelectronics makes strategic investment in Changhe Biotechnology

On January 16th, A strategic investment signing ceremony was held in Shanghai between Sifang Optoelectronics and Suzhou Changhe Biotechnology Co., Ltd. (hereinafter referred to as “Changhe Biotechnology”) . Sifang Optoelectronics acquired 57.14% of Changhe Biotechnology’s equity through a combination of capital transfer and capital increase using its own funds. This strategic integration with Changhe Biotechnology will allow the two companies to deeply integrate in areas such as product technology development, operational production, and sales channels, thereby leveraging Sifang Optoelectronics ‘ sensor technology…The company is expanding into more advanced biosafety testing instruments. Meanwhile, leveraging its expertise in core components within the sensor field, Sifang Optoelectronics will develop low-cost biosafety sensors for mass-market applications in home appliances, automobiles, and buildings. https://finance.eastmoney.com/a/202601193622798315.html
- Source: drugdu
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- January 20, 2026
Mingde Bio plans to acquire a 51% stake in Hunan Lanyi through capital increase and acquisition

On the evening of January 19th that Mingde Biotechnology…(002932) issued an announcement stating that the company plans to acquire Lanyi (Hunan) Medical Devices in the first phase of the acquisition through capital increase and equity acquisition.The company acquired 51% equity in Hunan Lanyi Limited Company (hereinafter referred to as “Hunan Lanyi”). After the initial acquisition, Hunan Lanyi became a controlling subsidiary of the company and was included in the company’s consolidated financial statements. Through negotiation among the parties involved, the total transaction price for this capital increase and equity acquisition of 51% equity in Hunan Lanyi was RMB 35.701 million. Meanwhile, if Hunan Lanyi’s relevant operating conditions from 2026 to 2028 meet the relevant preconditions stipulated in the Acquisition Agreement, the Company will further acquire the remaining equity of Hunan Lanyi in accordance with the agreement. After the completion of the aforementioned two-stage acquisition, the Company will hold a total ...
- Source: drugdu
- 66
- January 20, 2026

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