March 2026 can be considered a “bumper month” for global new drug development. From multiple sclerosis to IgA nephropathy, from prostate cancer to type 2 diabetes, several blockbuster drugs have delivered impressive results in Phase III clinical trials. 01 Fenebrutinib: A New Oral Treatment for Multiple Sclerosis Multiple sclerosis (MS) is a chronic autoimmune disease characterized by central nervous system inflammation, demyelination, and axonal damage, affecting more than 2.8 million people worldwide. The disease is protracted and recurrent, leading to limb disability and cognitive impairment in its later stages, severely impacting patients’ quality of life and placing a heavy burden on families and society. For a long time, clinical treatment of MS has been hampered by “injection dependence ,” with current treatments primarily consisting of injectable formulations, including interferon and monoclonal antibodies. While these can slow disease progression to some extent, they suffer from inconvenient administration, poor patient compliance, and ...
Recently, Gilead Sciences officially relinquished its development rights to ABI-4334 , a novel antiviral drug candidate for hepatitis B that is currently in Phase 1 clinical trials , returning all rights to the original developer, Assembly Biosciences. The development of ABI-4334 began at Assembly Biosciences. It is a next-generation capsid assembly regulator whose core mechanism of action is to inhibit the capsidation of hepatitis B virus pregenomic RNA and disrupt the capsid that enters hepatocytes, thereby preventing the formation of covalently closed circular DNA (cccDNA). Gilead’s collaboration with Assembly began in October 2023, when Gilead paid a $100 million upfront payment for priority access to all of Assembly’s existing and future projects, with a 12-year cooperation period . Subsequently, in December 2023, the two companies further deepened their collaboration, with Gilead acquiring two of Assembly’s recurrent genital herpes (HSV) treatment products for $35 million. ABI-4334, as a key hepatitis B ...
SHANGHAI, China – March 24, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that Health Canada has approved BILDYOS® (denosumab) injection 60 mg/mL and TUZEMTY® (denosumab, trade name: BILPREVDA® in the U.S. and Europe) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference product. “The approvals in Canada mark another significant regulatory milestone of the products following prior approvals in the U.S., EU and the UK, as well as a key milestone in our collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Together, we’ve translated our shared vision into tangible outcomes—bringing a new treatment option to patients in Canada and reinforcing our joint commitment to long-term access and value.” BILDYOS (denosumab injection) has been approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture, to increase bone mass ...
Drugdu.com expert’s response: Operating Class I medical devices does not require filing. This conclusion is primarily based on the following points of evidence and explanations: I. Classification Management of Medical Devices According to the “Regulations on the Supervision and Administration of Medical Devices” and related regulations, medical devices are classified into Class I, Class II, and Class III based on their risk levels, from low to high. Different categories of medical devices have varying management requirements in terms of operation and production. Class I medical devices: These are medical devices with a low risk level, and their safety and effectiveness can be ensured through routine management. These devices typically have simple structures and are easy to operate, such as surgical knives, surgical scissors, gauze bandages, and other basic medical supplies. Class II medical devices: These are medical devices with a moderate risk level that require strict control management to ensure ...
On March 20, CSPC Pharmaceutical Group (1093.HK) announced that its long-acting GLP-1/GIP receptor bipolar agonist polypeptide injection (SYH2082 injection) (hereinafter referred to as “SYH2082”) has been approved by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. SYH2082 is also expected to be approved by the U.S. Food and Drug Administration (FDA) in February 2026 to conduct clinical trials in the United States.SYH2082 is expected to be a leading-edge long-acting GLP-1/GIP receptor dual-biased agonist in clinical development, requiring monthly dosing. Leveraging the Group’s long-acting formulation technology platform, SYH2082 enables monthly dosing, improving patient compliance and ease of use. SYH2082 selectively activates the cAMP pathway, reducing β-arrestin recruitment, thereby decreasing receptor endocytosis and desensitization, enhancing efficacy, and prolonging the duration of action. Simultaneously, SYH2082 combines long half-life modification platform technology and long-acting formulation platform technology, aiming to achieve sustained weight loss within dosing ...
Primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, is a chronic, progressive autoimmune liver disease. Because it is asymptomatic in its early stages, it is called the “silent liver disease.” The patient’s immune system mistakenly attacks the small bile ducts in the liver, causing bile stasis and continuous damage to liver cells, eventually potentially leading to cirrhosis and liver failure. On March 19 , 2026, local time, GlaxoSmithKline (GSK) announced that the U.S. FDA has approved linerixibat for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC) . According to a GSK press release, this is the first drug approved for this indication in the United States . picture Publicly available information shows that Linerixibat is an oral IBAT inhibitor with the potential to treat cholestatic pruritus associated with primary biliary cholangitis (PBC). By inhibiting bile acid reabsorption, Linerixibat reduces various pruritus mediators in ...
On March 23, Rongchang Bio (688331.SH/09995.HK) announced that its independently developed original antibody-drug conjugate (ADC), vidicetuzumab (RC48, Aidixi®), has been officially approved for marketing by the National Medical Products Administration for a new indication. It is used to treat adult breast cancer patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) and liver metastases who have previously received at least one systemic therapy at the metastatic stage, or who have relapsed during or within 12 months after completing adjuvant chemotherapy. This is the fourth indication for which vedictetumab has been approved for marketing in China, following gastric cancer, urothelial carcinoma, and HER2-positive advanced breast cancer with liver metastasis. The clinical research evidence supporting this approval for marketing of a new indication is based on a randomized, open-label, parallel-controlled, multicenter phase III clinical trial (RC48-C012) conducted in China. This study demonstrated that vedicetumab has good efficacy and safety ...
“The industry is thinking about how to make machines understand people’s minds, while we are exploring how to make the brain understand machines,” said Dr. Liu Bing, founder of Mindtrix, at the 2026 Yabuli Forum, explaining their work. Currently, the global competition in brain-computer interfaces focuses on “reading” brain signals to achieve cool applications such as thought control. Mindtrix, however, focuses on feedback-based motor control based on “brain-computer dual learning” and visual reconstruction based on closed-loop large-scale stimulation. Dr. Liu Bing defines this as “reverse engineering”—they are tackling “writing” brain-computer interfaces, aiming to input precise electrical signal maps into the visual cortex of the brain to restore sight to those who are completely blind. These two directions outline two completely different philosophies of innovation. The former iterates and optimizes along a relatively clear path, while the latter attempts to establish a completely new basic communication protocol at the boundary between ...
Recently, Pfizer announced positive results from its proprietary, highly selective CDK4 inhibitor, Atirmociclib, in the Phase 2 clinical trial (FOURLIGHT-1) for the treatment of previously treated HR+/HER2- advanced or metastatic breast cancer. Based on this positive result, Pfizer believes that Atirmociclib has the potential to become the next blockbuster product in breast cancer treatment , and also gives confidence to other CDK4 inhibitors in development. 01 Next-generation CDK inhibitors Breast cancer is a common malignant tumor in women, most of which belong to the hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2-) subtype. The rise of CDK4/6 inhibitors has brought a breakthrough in precision treatment of this subtype of breast cancer, shifting the treatment modality for HR+/HER2- breast cancer patients from single-drug endocrine therapy to a combination of endocrine and targeted therapy. Currently, CDK4/6 inhibitors combined with endocrine therapy have become the standard treatment for HR+/HER2- advanced breast ...
Organiser:Hong Kong Trade Development Council Time:May 11 – May 13, 2026 Address:No.1 Expo Drive, Wan Chai District, Hong Kong Exhibition hall:Hong Kong Convention and Exhibition Centre Product range: Construction technology and hospital furniture, dental equipment and supplies, home medical products, hospital instruments, laboratory equipment, production and design solutions, medical supplies and consumables, physical therapy instruments and supplies exhibition area, rehabilitation and elderly care products, medical beauty instruments and supplies, technology hub, business services and publications About Hong Kong Medical and Healthcare Fair: The Hong Kong International Medical and Healthcare Fair is an event where international medical and healthcare professionals can keep abreast of the latest market trends. It provides an ideal platform for industry insiders to learn about the latest developments in the medical sector and forge close connections within the industry.
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