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 ...
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 ...
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 ...
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 ...
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 ...
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
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 ...
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 ...
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 ...
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 ...
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