PharmaFocus Today – Page 7 – media

Fosun Pharma resubmits its application for listing of Furuitinib

On January 8, Fosun Pharma announced that its subsidiary, Fosun Wanbang, had its drug registration application for Furetinib Succinate Capsules accepted by the National Medical Products Administration. The indication for this application is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Furetinib is a highly effective ALK/ROS1 inhibitor with high CNS penetration . It has demonstrated good efficacy in clinical studies, showing significant efficacy against central nervous system metastases, and exhibiting a good safety profile . In March 2025, Fosun Pharma initially submitted a marketing application for Furetinib, but voluntarily withdrew it in October, citing the need to further refine the registration materials according to the latest technical requirements of the National Medical Products Administration (NMPA). Interim analysis results from the Phase II REMARK study showed that the progression-free survival (PFS) in the fosetinib (160 mg once daily) group ...
- Source: drugdu
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- January 9, 2026
the treatment of generalized anxiety disorder

Luye Pharma Group announced that the Center for Drug Evaluation of the National Medical Products Administration of China has formally accepted the new indication marketing application for the Group’s Class 1 innovative drug Ruoxinlin® ( toludivinlafaxine hydrochloride extended-release tablets), which is intended for the treatment of generalized anxiety disorder (GAD). This application for a new indication marks another milestone for Ruoxin® since its approval for marketing in November 2022 for the treatment of depression. As the review process for the new indication progresses, this product is expected to become the first serotonin, norepinephrine, and dopamine triple reuptake inhibitor (SNDRI) for the treatment of GAD in China, benefiting more patients. It rapidly and comprehensively improves anxiety symptoms and has a good safety profile. Anxiety disorders are the most common mental disorders in China.1 Data from 2023 shows that approximately 58.67 million people in China suffer from this disease.2 GAD is a ...
- Source: drugdu
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- January 9, 2026
The first prescription of the rare disease innovative drug sradpa in mainland China was issued in Shunyi.

On the morning of January 6, Beijing Friendship Hospital Shunyi Branch issued the first prescription in mainland China for the innovative rare disease drug Seladelpar, which is specifically used to treat primary biliary cholangitis. This not only marks a significant step forward in the treatment of rare diseases in my country, but also provides a model for the introduction of more innovative drugs. At the Shunyi branch of Beijing Friendship Hospital, patient Liu Li (pseudonym) received the first box of sradpa prescribed in mainland China. Liu Li had been diagnosed with primary biliary cholangitis for many years. After trying her current first-line treatments, her indicators did not improve significantly. After thorough communication, she decided to try the innovative rare disease drug sradpa. “I hope this innovative drug can improve my condition, and I also hope that such drugs will be included in medical insurance as soon as possible, benefiting more ...
- Source: drugdu
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- January 9, 2026
Yilian Bio and Roche Sign Another Exclusive Licensing Agreement

Suzhou, China, January 9, 2026 – Yilian Bio today announced a new exclusive licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for its YL201 project, which will jointly advance the development and commercialization of this innovative antibody-drug conjugate (ADC) targeting B7H3 in multiple solid tumor indications. Under the terms of the agreement, Yilian Bio will grant Roche the exclusive rights worldwide (excluding Mainland China, Hong Kong SAR, and Macau SAR) to develop, manufacture, and commercialize the YL201 project. Yilian Bio will receive an upfront payment of US$570 million plus near-term milestone payments, and will be entitled to additional development, registration, and commercialization milestone payments, as well as tiered royalties based on net sales following overseas approval of YL201. This exclusive licensing agreement for the YL201 project builds upon the successful collaboration initiated by both parties in January 2024 regarding the YL211 (c-Met ADC) project. Yilian Bio and Roche will ...
- Source: drugdu
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- January 9, 2026
“AI+RNA” Small Molecule Innovative Drug Approved for Clinical Trials

On January 7, ReviR Therapeutics announced that it has recently received the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration (NMPA) for its small molecule pipeline RTX-117, indicated for the treatment of Charcot-Marie-Tooth disease (CMT). The company plans to initiate Phase I clinical trials in the first quarter of 2026. Reportedly, RTX-117 is China’s first Class 1 innovative drug pipeline targeting CMT. It is also the first project to enter clinical development from a series of rare disease drug pipelines co-developed by ReviR and XtalPi through AI + robotic-assisted research. Prior to this, the pipeline had already obtained IND approval and Orphan Drug Designation from the U.S. FDA. CMT is listed as the 17th disease in the “First List of Rare Diseases” announced by the National Health Commission in 2018. It is a highly progressive and disabling rare disease with a global prevalence of 17.7~40 per ...
- Source: drugdu
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- January 8, 2026
Eli Lilly signs $1.3bn obesity-focused research deal with Nimbus

li Lilly has signed a research and licence agreement with Nimbus Therapeutics, aiming to develop a new oral weight loss drug, deepening ties between the two companies. The latest partnership will see Lilly pay Nimbus $55m upfront, with $1.3bn on the line in developmental and commercial milestone payments. Royalties are also included for any oral drug approved as a result of the research collaboration. In return for the payments, Nimbus is tasked with using its computational chemistry and structure-based drug design to discover a small molecule drug for the treatment of obesity and other metabolic diseases. Lilly and Nimbus started working together in a deal worth up to $496m inked in 2022. In that partnership, Nimbus and Lilly were targeting AMP-activated protein kinase (AMPK), an enzyme important in the body’s energy pathways, for cardiometabolic diseases. “We are pleased to deepen our collaboration with Nimbus, a team that has demonstrated exceptional ...
- Source: drugdu
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- January 8, 2026
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
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- 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

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