media – Page 16 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

When animal testing is no longer a “must-have” option

Recently, the U.S. Senate unanimously passed the FDA Modernization Act 3.0 , requiring the FDA to revise its regulatory rules within one year of the act’s enactment— replacing the previous term “animal testing” with “non-clinical trials .” This new concept does not eliminate animal research, but rather integrates it, along with cutting-edge technologies such as AI models, organoids, and organ-on-a-chip, into a more scientific evaluation system. 01 The reform began The direct background of the FDA Modernization Act 3.0 can be traced back to the FDA Modernization Act 2.0 passed in 2022. In Act 2.0, Congress removed the statutory requirement that “animal testing is mandatory” in the development of new drugs , shifting the FDA’s legal authorization from “animal testing as a necessary prerequisite” to “allowing the use of multiple non-clinical methods to support safety evaluation.” However, this legal change has not been simultaneously reflected in the FDA’s specific regulatory ...
- Source: drugdu
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- January 8, 2026
Clinical Trial Application for Innovative Drug SAL0145 Injection Accepted

On January 7, Salubris (002294.SZ) announced that the clinical trial application (IND) for its self-developed innovative drug, SAL0145 Injection, has been formally accepted by the National Medical Products Administration (NMPA). According to relevant regulations, if no negative or questioning feedback is received from the Center for Drug Evaluation (CDE) within 60 days, the applicant may proceed with the clinical trials as per the submitted protocol. SAL0145 is designed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH). MASH is an advanced form of metabolic dysfunction-associated steatotic liver disease (MASLD), a condition that affects approximately 30% of the adult population worldwide. In terms of financial performance, Salubris reported a revenue of 3.241 billion yuan and a net profit attributable to shareholders of 581 million yuan for the first three quarters of 2025. https://finance.eastmoney.com/a/202601073611609222.html
- Source: drugdu
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- January 8, 2026
Hengrui Pharma’s innovative drug Aizerli approved for advanced gastric cancer

CNSTOCK News (Reporter: He Xinyi) – On the evening of January 7, Hengrui Pharma announced that its subsidiary, Suzhou Suncadia Biopharmaceuticals Co., Ltd., received notification from the National Medical Products Administration (NMPA) regarding the approval of its self-developed Class 1 innovative drug, Relafusp α Injection (Trade name: Aizerli), for market launch. The drug is indicated for use in combination with fluoropyrimidines and platinum-based chemotherapy as a first-line treatment for patients with locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, specifically those with PD-L1 expression (CPS ≥ 1) confirmed by validated testing. Notably, Relafusp α is the world’s first anti-PD-L1/TGF-βRII bispecific antibody fusion protein to be approved for marketing. Hengrui Pharma stated that Relafusp α is a bifunctional fusion protein developed independently with proprietary intellectual property rights. It exerts anti-tumor effects by specifically blocking the PD-1/PD-L1 interaction while simultaneously neutralizing TGF-β within the tumor microenvironment. According to ...
- Source: drugdu
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- January 8, 2026
Medical Fair India

Organiser：Messe Düsseldorf GmbH (Germany) Time：January 29 – 31, 2026 Address：pragati maidan, Karol Bagh, New Delhi, Delhi 110008 Exhibition hall：Pragati Maidan Product range: Medical Equipment: Medical electronic instruments, ultrasonic instruments, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, blood dialysis equipment, respiratory equipment, hospital ward, operating room, and emergency room equipment, hospital office equipment, laboratory equipment, etc. Disposable Consumables: Disposable medical supplies, dressings and hygiene materials, various surgical instruments, etc. Medical Devices: Medical and healthcare devices, home healthcare products, physical therapy, orthopedic technology, etc. Medical Peripherals: Information and communication technology, medical services, and publishing, etc. About Medical Fair India ： Medical Fair India, held in New Delhi, India, is one of the most renowned exhibitions in the medical field in South and Central Asia. It continues the tradition of bringing together the best products from the global and Indian healthcare sectors, marking years of medical ...
- Source: drugdu
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- January 8, 2026
Good News for Hematologic Malignancy Patients! BeiGene’s BCL-2 Inhibitor Approved for Two Indications in China

On January 5, 2025, the official website of the National Medical Products Administration (NMPA) announced that sonrotoclax tablets, a B-cell lymphoma 2 (BCL-2) inhibitor independently developed by BeiGene, has been officially approved for marketing in China, with two indications obtained simultaneously: for the treatment of adult patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received anti-CD20 therapy and BTK inhibitor (BTKi) therapy. This landmark approval makes sonrotoclax the third BCL-2 inhibitor worldwide and the second domestic one in China. It marks a major breakthrough in BeiGene’s pipeline layout in the field of hematologic malignancies, providing a new-generation treatment option with the potential to be best-in-class for patients with relapsed and refractory B-cell malignancies. PART.01 Next-Generation BCL-2 Inhibitor: Mechanistic Optimization and Pharmacokinetic Breakthroughs The BCL-2 protein family is a key regulator of cell ...
- Source: drugdu
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- January 7, 2026
Devote to TCM’s Global Footprint, Root in Public Welfare, and Uphold Corporate Commitment!

At present, Buchang Pharmaceutical has more than 170 products (including exclusive and non-exclusive ones) included in the 2025 Edition of the National Medical Insurance Catalogue. The number of exclusive products stands at 73 (63 proprietary Chinese medicines, 9 chemical drugs, and 1 vaccine). The company’s Class 1 New Drug, Epoetin alfa for Injection, and its first biosimilar, Adalimumab Injection, are advancing at an accelerated pace, and the company’s innovation-driven transformation is gathering momentum. Behind the performance growth lies the company’s continuous breakthroughs in key business areas such as product innovation, international layout, and technological upgrading. Today, from “product export” in traditional manufacturing to “technical standard export” in high-end industries, and from “going global” through single-item trade to “integrating into the global market” via globalized operations, the overseas journey of Chinese enterprises has entered the 2.0 era. Among these, traditional Chinese medicine (TCM), as a unique industrial card carrying thousands of ...
- Source: drugdu
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- January 7, 2026
Takeda and Protagonist seek FDA approval for rusfertide to treat PV

Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV). The first-in-class, subcutaneously administered hepcidin mimetic peptide, rusfertide is intended to regulate iron homeostasis and red blood cell production to help manage haematocrit levels in PV patients. The NDA follows positive results from the 32-week primary analysis and 52-week evaluation of the Phase III global placebo-controlled, randomised VERIFY trial. In this trial, rusfertide achieved the primary endpoint and all four key secondary endpoints. The study found that patients treated with the therapy alongside standard of care (SoC) therapy achieved a notably higher response rate than those given a placebo with SoC. The application also includes findings from the earlier Phase II REVIVE study. Rusfertide has received breakthrough therapy designation from the FDA, recognising its potential to offer substantial improvement ...
- Source: drugdu
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- January 7, 2026
Aktis Oncology kicks 2026 IPO cycle off with $210m target

The IPO class of 2026 is likely to receive its first incumbent, after Aktis Oncology set its sights on a public listing that could see proceeds of around $210m. The cancer treatment-focused biotech first revealed plans for an IPO in mid-December, but the figure touted then was around the $100m mark. In an updated registration statement with the US Securities and Exchange Commission (SEC), Aktis is offering 11,775,000 shares of common stock at a price between $16 and $18 per share. The company would trade under the ticker “AKTS” on the Nasdaq Global Market. If the listing goes ahead at the midpoint of that range, Aktis anticipates raising $181.7m in proceeds. If underwriters take up their 30-day option, that value would rise again to $209.6m. Aktis’ pipeline focuses on radiopharmaceuticals, a type of drug that uses a radioactive isotope with a targeting molecule to destroy cancer cells. The biotech specifically ...
- Source: drugdu
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- January 7, 2026
Rongjiekang RT2831 bispecific antibody drug receives Orphan Drug Designation from the US FDA

Nanjing Rongjiekang Biotechnology Co., Ltd.’s independently developed innovative drug RJK-RT2831 recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation will facilitate access to relevant policy support for RJK-RT2831’s subsequent research, development, registration, and commercialization in the United States, including research funding, tax breaks for clinical research expenses, exemption from prescription drug user fees, and accelerated market approval. The Nanjing Rongjiekang RT2831 project is a bispecific nanobody drug targeting specific antigens on the surface of malignant hematological tumor cells. It has demonstrated excellent safety and efficacy potential in non-clinical studies. Currently, the project is undergoing Phase I clinical trials in China. There remains a significant unmet medical need for patients with acute myeloid leukemia (AML), and RJK-RT2831 holds promise for providing AML patients with novel treatment options and greater clinical benefits. The FDA’s orphan drug designation ...
- Source: drugdu
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- January 7, 2026
FDA approves new motion sickness drug

Vanda Pharmaceuticals recently announced that its core pipeline product, traditional vomiting (brand name: NEREUS™), has been approved by the FDA for the prevention of exercise-induced vomiting. 40 years since the approval of scopolamine transdermal patches in 1979. This approval is a significant milestone. This approval is primarily based on three pivotal clinical trials: two Phase III real-world induced trials conducted at sea and a supportive study, with all participants having a clear history of motion sickness. In the Motion Syros trial (during November 2021 to April 2023, a total of 365 adult subjects participated in 34 sea trials in the waters near the United States, during which nausea and vomiting symptoms were assessed every 30 minutes using a standardized questionnaire, and the sailing time was approximately 4 hours), the incidence of vomiting in the drug group was significantly lower than that in the placebo group (170 mg group 18.3%, 85 ...
- Source: drugdu
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- January 7, 2026

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