PharmaFocus Today – Page 23 – media

Amgen buys Dark Blue Therapeutics in $840m oncology deal

Amgen has agreed to acquire UK-based biotech Dark Blue Therapeutics for up to $840m, making it the first pharma takeover of 2026. Through this transaction, Amgen will gain access to Dark Blue’s pipeline of oncology assets – including DBT 3757, an investigational myeloid/lymphoid leukaemia translocation 1 and 3 (MLLT1/3)-targeted protein degrader. Currently in investigational new drug (IND)-enabling studies, DBT 3757 is being developed for the treatment of acute myeloid leukaemia (AML), with preclinical work having already highlighted its anticancer potential. According to Dark Blue, the therapy’s differential mechanism to marketed treatments, as well as its potential to boost the durability of AML remission, builds rationale for the drug’s further development, which may be used both as a monotherapy and in combination with other AML treatment options. Amgen’s executive VP of R&D, Jay Bradner, noted that the acquisition would assist the company’s strategy of “investing early into rising medicines” that harness ...
- Source: drugdu
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- January 8, 2026
Kexing Biopharm’s licensed-in product, Albumin-bound Paclitaxel, has been approved for marketing by Argentina’s ANMAT

At the beginning of 2026, Kexing Pharmaceutical (688136.SH) received good news regarding its overseas commercialization. The company’s anti-tumor drug, Paclitaxel for Injection (Albumin-bound) developed in collaboration with Haichang Bio, was granted a registration certificate by the National Administration of Drugs, Food and Medical Devices of Argentina (ANMAT), officially entering the Argentine pharmaceutical market. This marks another key breakthrough for Kexing Pharmaceutical’s internationalization strategy in the Latin American region. The high demand for anti-tumor drugs highlights the potential of the pharmaceutical market. Argentina is the second-largest economy in South America after Brazil and the sixth-largest trading partner of China in Latin America. Its per capita GDP in 2024 is expected to be 14,000 US dollars, placing it in the category of upper-middle-income countries. In recent years, the size of its pharmaceutical market has been steadily increasing, with strong demand. According to research data from Grand View Horizon, the size of Argentina’s ...
- Source: drugdu
- 60
- January 8, 2026
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
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

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