PharmaFocus Today – Page 12 – media

J&J’s subcutaneous monoclonal antibody combination therapy receives further FDA approval; Autoimmune CAR-T therapy granted FDA Breakthrough Therapy Designation

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.
- Source: https://bydrug.pharmcube.com/news/detail/bb1becb2bd627f90903fc00877ae5c22
- 66
- February 2, 2026
Why is the development of AI-based antiviral drugs a niche field yet a necessity?

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 ...
- Source: https://finance.eastmoney.com/a/202601303636738175.html
- 77
- February 1, 2026
Pakistan issues final antidumping ruling on Chinese cephalosporin

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 ...
- Source: https://mp.weixin.qq.com/s/FxBxneJlKl7M_oJY9x9tmA
- 76
- February 1, 2026
Samsung Biotech “Soars”

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 ...
- Source: https://news.yaozh.com/archive/47020.html
- 64
- February 1, 2026
Strategic Collaboration with AstraZeneca, Potential Transaction Value Up to $18.5 Billion

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 ...
- Source: https://finance.eastmoney.com/a/202601303636313384.html
- 83
- January 31, 2026
Farsight Medical Announces First Patient Dosed in Phase II Clinical Trial of RN-0001, a World-First Therapy for Acute Pancreatitis

Farsight Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Farsight Medical”) is dedicated to the field of cyclophilin inhibitors. Leveraging its proprietary technology platform, the company focuses on mechanistic research and drug development centered around cyclophilin A (CypA)-related inflammatory pathways and cyclophilin D (CypD)/mitochondrial permeability transition pore (mPTP)-related mitochondrial damage. The company recently announced that its global first-in-class innovative drug, RN-0001, for the treatment of acute pancreatitis (AP) complicated by systemic inflammatory response syndrome (SIRS), successfully completed the first patient enrollment and dosing in its Phase II multicenter clinical trial on January 28, 2026, at the lead site, West China Hospital of Sichuan University. Currently, RN-0001 has been approved by the NMPA to conduct Phase II clinical trials. This newly initiated multicenter study aims to systematically evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of the drug in patients with acute pancreatitis.
- Source: https://bydrug.pharmcube.com/news/detail/d9c3d25d741a604efb7e07c485b06c94
- 91
- January 31, 2026
Boao Lecheng CGT project reaches 20 items! The first autologous NK therapy for eight types of cancer in China has been approved, costing 49,800 yuan per treatment

Recently, the nation’s first autologous NK cell adjuvant therapy technology covering eight types of tumor indications was officially approved for clinical application at West China Lecheng Hospital. The cost of a single treatment session is 49,800 yuan, with a total of 6 sessions per course, and the total cost for the entire course is approximately 298,800 yuan. This treatment covers lung cancer, breast cancer, stomach cancer, pancreatic cancer, ovarian cancer, liver cancer, prostate cancer, and colorectal cancer. According to a January 28 report from the Boao Lecheng International Medical Tourism Pilot Zone Administration, with the recent approval of four new cell and gene therapy (CGT) projects, Lecheng has now achieved a total of 20 CGT projects that have been translated into clinical applications. Recent additions include: Shulan (Boao) Hospital: Autologous NK Cell Therapy Project Ciming Boao International Hospital: Umbilical cord mesenchymal stem cell therapy for type 2 diabetes (for patients ...
- Source: https://mp.weixin.qq.com/s/pjUOs4554LmRv1uJdHWQow
- 176
- January 31, 2026
Yangtze River Pharmaceutical Group is ramping up its investment in the 10 billion yuan contrast agent market, aiming to challenge Hengrui

According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Yangtze River Pharmaceutical Group’s application for a Class 4 generic drug, iodofol injection, has been accepted. This is not Yangtze River’s first foray into this product. As early as November 2025, Yangtze River independently submitted a marketing application for this product and it was accepted by the CDE. Behind these two applications lies the pharmaceutical giant’s deep ambition for the CT contrast agent market. Ioflufenicol injection was originally developed by Mallinckrodt in the United States. It is a non-ionic, low-permeability, water-soluble, monomeric X-ray contrast agent. In 1988, ioflufenicol received FDA approval for marketing in the United States under the brand name Optiray. This product entered the Chinese market in 1999 and was included in the Class A medical insurance program in 2009. According to data from Yaozhi, the domestic CT contrast agent ...
- Source: https://news.yaozh.com/archive/46998.html
- 75
- January 31, 2026
Simcere Pharmaceutical’s TL1A/IL-23p19 bispecific antibody goes global, partnering with Boehringer Ingelheim to expand the global inflammatory bowel disease market.

Recently , Simcere Pharmaceutical (2096.HK) announced that it has entered into an exclusive licensing and collaboration agreement with Boehringer Ingelheim, a leading global pharmaceutical company, to jointly develop Simcere’s self-developed TL1A/IL-23p19 bispecific antibody SIM0709 for the treatment of inflammatory bowel disease. Under the agreement, Boehringer Ingelheim acquires global rights to the project outside of Greater China. Simcere Pharmaceutical will receive an upfront payment, plus payments of up to €1.058 billion based on success in development, registration, and commercial milestones, in addition to royalties from net sales outside of Greater China. More than 3 million people worldwide are affected by inflammatory bowel disease (IBD). This disease can accompany patients throughout their lives and progresses continuously, often leading to frequent hospitalizations and surgeries, and severely impacting quality of life. Current medical treatments cannot completely prevent or reverse the disease and its complications, resulting in a significant unmet clinical need ...
- Source: https://news.yaozh.com/archive/47027.html
- 71
- January 31, 2026
Within 29 days of its listing, Insilicon has secured four collaborations.

Recently , Insilicon announced a strategic collaboration with Qilu Pharmaceutical Group and its subsidiary, Shanghai Qilu Pharmaceutical Research Center, on drug development worth over HK$931 million . According to the agreement, the two parties will rely on Insilicon’s Pharma.AI platform to develop small molecule inhibitors for cardiovascular and metabolic diseases targeting specific targets. Insilicon will be responsible for the design and optimization of small molecule drugs, while Qilu Pharmaceutical will be responsible for subsequent development and commercialization. It is understood that Insilicon was listed in Hong Kong on December 30, 2025, less than a month ago. This cooperation with Qilu Pharmaceutical is the fourth cooperation that has been implemented since its listing. 01 Reshaping the R&D Paradigm In the pharmaceutical industry, traditional new drug development is characterized by high investment, high risk, and long cycles. There is a saying in the industry that “the ‘double ten rule'” ...
- Source: drugdu
- 66
- January 31, 2026

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