PharmaFocus Today – Page 2 – media

Health Canada Approves Henlius’ BILDYOS® (Denosumab Injection) and TUZEMTY® (Denosumab Injection), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

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 ...
- Source: drugdu
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- March 25, 2026
Shijiazhuang Pharmaceutical Group’s GLP-1/GIP receptor bidirectional agonist polypeptide long-acting injection (SYH2082 injection) has been approved for clinical trials in China.

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 ...
- Source: drugdu
- 47
- March 24, 2026
Big news! GSK’s new oral liver disease drug approved for marketing in the United States.

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 ...
- Source: drugdu
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- March 24, 2026
the treatment of breast cancer with low HER2 expression and liver metastases.

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 ...
- Source: drugdu
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- March 24, 2026
Climbing the “Mount Everest of Brain-Computer” requires a complete logistical support system to support long-term expeditions.

“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 ...
- Source: drugdu
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- March 24, 2026
Pfizer’s potential “blockbuster” drug achieves success in Phase 2 clinical trials

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 ...
- Source: drugdu
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- March 24, 2026
Eli Lilly invests $3 billion in China

Recently, Eli Lilly announced plans to invest a total of $ 3 billion over the next ten years to fully expand its supply chain capacity in China . According to the plan, the $3 billion investment will adopt a dual-track model of ” internal expansion + external cooperation “: on the one hand, it will leverage the technological and talent advantages of the Suzhou factory to strengthen the synergistic production capacity of incretin injection; on the other hand, it will add oral solid dosage form production capacity in Beijing and cooperate with multiple local production partners to release incremental production capacity. As a key move in this round of investment, Eli Lilly also announced a strategic partnership with Kanglong Chemical , a leading domestic CDMO company , on the same day. The initial investment of $200 million will support Kanglong’s technological capabilities, with plans to gradually expand the scale as ...
- Source: drugdu
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- March 23, 2026
Medtronic invests $550 million in neurointerventional surgery.

According to recent foreign media reports, global medical device giant Medtronic announced that it will acquire Scientia Vascular for $550 million to strengthen its stroke treatment portfolio. Image source: Fierce Biotech Scientia Vascular is a company specializing in the manufacture of specialized guidewires, microcatheters, and access products for reaching complex blood clots deep in the brain. According to data from PharmNet Medical Devices, the company has already launched 16 products in the United States. In 2021, Scientia completed a $50 million funding round, which the company reportedly used to accelerate sales, marketing, and new product development in its core neurovascular stroke market, as well as peripheral vascular and interventional oncology-related markets. Scientia’s process involves etching slots into a solid nickel-titanium alloy tube to form a closed loop and interconnected beams—allowing the guidewire to effectively transmit torque while meandering through the brain’s small, winding blood vessels. The company states that this ...
- Source: drugdu
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- March 23, 2026
Roche’s blockbuster new drug receives approval for a new indication, becoming the world’s first to do so.

Diffuse large B-cell lymphoma ( DLBCL) is the most common type of non-Hodgkin lymphoma (NHL), accounting for 31%–34% of NHL cases globally and 45.8% in China. The incidence rate increases with age. Even after first-line treatment, 30%–40% of DLBCL patients face relapse or refractory outcomes, resulting in a poor prognosis and challenging survival.On March 13, 2026, according to the latest announcement on the official website of the National Medical Products Administration (NMPA) of China , Roche (China) Investment Co., Ltd. ‘s application for a new indication for injectable veportuzumab has been approved for marketing in China . According to Roche’s press release, the indication is: this product in combination with rituximab , gemcitabine, and oxaliplatin (Pola-R-GemOx) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for hematopoietic stem cell transplantation. Public information shows that vedotin (Urithema®, Polivy®) is an antibody-drug conjugate (ADC) targeting ...
- Source: drugdu
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- March 23, 2026
Lunan Pharmaceutical’s carfilzomib API receives dual approval from China and the US for market launch.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a marketing authorization notice for carfilzomib issued by the National Medical Products Administration . This approval further enriches the company’s anti-tumor active pharmaceutical ingredient (API) product line. The product, manufactured using the same production line and process, has also been submitted for US approval, providing a better option for domestic and international pharmaceutical formulation customers. Carfilzomib, as a second-generation proteasome inhibitor, exerts significant anti-proliferative and pro-apoptotic effects on tumor cells by irreversibly binding to the 20S proteasome active site. Its high selectivity results in a lower risk of neurotoxicity, and it is well tolerated by patients. Clinical data confirm that it has a reliable safety advantage in the treatment of multiple myeloma and is the preferred clinical option. Established in 2017, the International Drug R&D Center adheres to an international strategy of “based in China, radiating ...
- Source: drugdu
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- March 23, 2026

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