On January 29, 2026, PotentiaBiotech supported CSPC Group in obtaining implied approval for clinical trials from the National Medical Products Administration (NMPA) for its independently developed SYS6055 Injection, with the application acceptance number: CXSL2500947. This marks China’s first in vivo CAR-T therapy to receive clinical trial approval, indicated for relapsed/refractory aggressive B-cell lymphoma. PotentiaBiotech extends its warm congratulations on this milestone achievement! Picture 1: From the Wechat Public Account “PotentiaBiotech” About CSPC Group CSPC Holding Group Co., Ltd. was established in 1997. Guided by its long-standing philosophy of “Developing Quality Medicines for China and Benefiting People Worldwide”, the company has sustained double-digit growth in its core operating indicators for many years through innovation-driven development. It has now grown into an international innovation-oriented enterprise with 28,000 employees. Its listed subsidiary on the Hong Kong Stock Exchange (01093.HK) is a constituent stock of the Hang Seng Index, and ranks 19th globally in ...
LimX Dynamics announced the completion of a $200 million Series B financing round, with Cornerstone Capital as a participant. With full-stack technology, we grasp the pivotal capabilities that drive embodied intelligence toward real-world deployment. As we step into 2026, with the strong support of our existing and new shareholders as well as partners, LimX Dynamics will scale up its investment in R&D and market expansion. Grounded in three core competencies: proprietary hardware design and manufacturing, cerebellum foundation models, and the embodied Agentic OS, LimX Dynamics focuses on breakthroughs in the core technology of fusing the “brain and cerebellum” for embodied intelligence. The company advances original innovation in general-purpose humanoid robots and modular base robots, and will further expand its presence in both the Chinese and global markets through product engineering and the development of a supply chain ecosystem. Over the past two months, LimX Dynamics has successively launched two pivotal ...
China has always been a major exporter of raw pharmaceutical materials, and how to develop the export of Western medicine products towards higher added value has attracted much attention. Chinese medicineData released on January 29 by the China Chamber of Commerce for Health Products Import and Export shows that in 2025, China’s exports of Western medicine preparations amounted to US$8.841 billion, a year-on-year increase of 27.29%. Among them, the export value of preparations accounted for a record high of 15.85% of the total exports of Western medicine products. Furthermore, in 2025, the export value of pharmaceutical preparations accounted for 7.94% of the total export value of pharmaceutical products, showing a significant upward trend. This reflects the continuous upgrading of China’s pharmaceutical industry from upstream intermediates and raw materials to downstream high-value-added fields such as pharmaceutical preparations. In 2025, China’s exports of Western medicine preparations showed a trend ...
According to Chengdu Pioneer…According to reports, Chengdu Pioneer recently signed a cooperation agreement with a subsidiary of Kangzhe Pharmaceutical Holdings Limited (hereinafter referred to as ” Kangzhe Pharmaceutical “). Chengdu Pioneer will provide Kangzhe Pharmaceutical with innovative drugs targeting multiple specific targets.The company provides development services. Chengdu Pioneer will rely on its DNA-encoded compound library (DEL) technology platform and Qualcomm…HAILO, an AI-driven molecular optimization platform, provides Kangzhe Pharmaceuticals with a one-stop development service from target validation to preclinical compound candidates (PCCs). This initiative aims to efficiently generate drug candidates with “first-in-class” (FIC) or “best-in-class” (BIC) potential.
Drugdu.com expert’s response: Selling medical devices requires obtaining a Medical Device Business License, which is based on a comprehensive consideration of legal mandatory requirements, ensuring product quality and safety, maintaining market order, enhancing corporate competitiveness, avoiding operational risks, and promoting standardized corporate management. The specific analysis is as follows: I. Legal Mandatory Requirements According to relevant laws and regulations such as the Regulations on the Supervision and Administration of Medical Devices, enterprises selling medical devices must obtain the corresponding Medical Device Business License. This is a mandatory regulatory measure by the state for the circulation of medical devices, aiming to ensure the safety, effectiveness, and traceability of products from the factory to consumers. Operating without a license will result in severe legal penalties, including confiscation of illegal gains, fines of up to 20 times the value of the goods (with a minimum of 50,000 yuan), and in serious cases, revocation of ...
J&J’s Subcutaneous Monoclonal Antibody Combination Therapy Receives Another FDA Approval. Recently, the U.S. FDA approved Johnson & Johnson’s subcutaneous formulation of its CD38-targeting monoclonal antibody, Darzalex Faspro® (daratumumab and hyaluronidase-fihj), in combination with bortezomib, lenalidomide, and dexamethasone (the VRd regimen). This combination is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In the study, a total of 395 patients were randomized, with 197 receiving Darzalex Faspro in combination with VRd and 198 receiving VRd alone.
As AI-driven drug development moves beyond the initial stage of technical feasibility verification, technology and capital in the biopharmaceutical field are rapidly converging on this track, but this has also exacerbated the resource differentiation among different research directions: compared to the more popular drug development for oncology and autoimmune diseases due to AI support, there are very few AI-driven drug development projects launched in the already relatively quiet field of infectious disease drug development such as tuberculosis, malaria, and Nipah virus. However, while AI-driven antiviral drug development is a niche area, it is a necessity. Currently, innovative drugs in the public health field…Drug development faces numerous challenges, including R&D investment far exceeding the “double ten cycle” (meaning that the average R&D cycle for an innovative drug from initiation to final market launch exceeds 10 years and the R&D cost exceeds $1 billion), greater uncertainty in commercial returns, scarcity of ...
On January 14, 2026, the National Tariff Commission of Pakistan issued an updated announcement on Case No. ADC68, making an affirmative final determination on antidumping of cefadroxil originating in or imported from China, and deciding to impose antidumping duties on the products in question. Specifically, the anti-dumping duty is 8.61% for the manufacturer/exporter, Zhejiang Anglikang Pharmaceuticals Co., Ltd., and 11.81% for other Chinese manufacturers/exporters. This measure is effective from September 17, 2025, and is valid for five years. This case involves products under Pakistani tariff code 2941.9090, which are used to treat bacterial infections such as skin, throat, tonsil, and urinary tract infections. Products in question that are raw materials for export only, used in foreign aid projects, or fall under any export or foreign aid project duty-free schemes stipulated in the Customs Act 1969 are not subject to anti-dumping duties. On May 21, 2025, Pakistan initiated an anti-dumping investigation ...
Samsung Bio has been inundated with orders over the past year. Samsung Biologics recently announced its latest financial results for the full year 2025: revenue of 4.557 trillion won (approximately US$3.1 billion), up 30.3% year-on-year, and revenue profit up 56.6% year-on-year. Furthermore, according to the company’s forecast, even without taking into account the potential revenue contribution from the acquisition of the US factory, revenue in 2026 can still grow by 15-20%. Samsung Biologics’ confidence stems not only from its continued investment in production capacity, but also from the fact that, against the backdrop of rising geopolitical uncertainty, the “safer” Samsung Biologics is being chosen by more and more MNCs. In December of last year, Samsung Biologics acquired 100% of GSK’s biopharmaceutical manufacturing facility in Rockville for $280 million, expanding its production base in the United States and further “consolidating” its partnership with MNC. Despite the ...
CSPC Pharmaceutical Group (01093) announced that it has signed a strategic research and development cooperation and licensing agreement with AstraZeneca, a global leader in biopharmaceuticals, to develop innovative long-acting peptide drugs. According to the agreement, CSPC will receive an upfront payment of US$1.2 billion and is entitled to potential R&D milestone payments of up to US$3.5 billion, potential sales milestone payments of up to US$13.8 billion, and sales royalties based on up to double-digit percentages of the annual net sales of the relevant products, with a potential total transaction value of up to US$18.5 billion. Under the terms of the agreement, the two parties will engage in comprehensive strategic cooperation in the discovery of innovative peptide molecules and the development of long-acting delivery products. CSPC Pharmaceutical Group will grant AstraZeneca exclusive rights globally (excluding Mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize the relevant licensed ...
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