PharmaFocus Today – Page 5 – media

First Domestic FGFR1/2/3 Inhibitor! HUTCHMED’s ATLED® (Fanregratinib) Receives Conditional NMPA Approval | Approval Alert

On August 28, 2026, HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453) has been granted conditional approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®. Intrahepatic cholangiocarcinoma is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2%-15.0% of primary liver cancers and ranking as the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has been continuously rising, with a 5-year overall survival rate of approximately 9%. Approximately 10%-15% of intrahepatic cholangiocarcinoma patients worldwide harbor FGFR2 fusions or rearrangements. This approval is supported by data from the Phase II registration cohort ...
- Source: drugdu
- 96
- September 2, 2026
Simcere Zaiming Signs Exclusive Licensing Agreement with Roche for Global Development of Tri-Specific Antibody SIM0660 | Partnership News

On September 1, 2026, Simcere Zaiming, the anti-tumor innovative drug subsidiary of Simcere Pharmaceutical Group (02096), announced that it has signed an exclusive licensing agreement with Roche for the global development and commercialization of SIM0660, a CD79a/CD19/CD3 tri-specific antibody with therapeutic potential for multiple B-cell-related diseases. Under the terms of the agreement, Roche will receive exclusive worldwide rights for the development, manufacturing, and commercialization of SIM0660. Simcere Zaiming will be eligible to receive total transaction payments of up to $1.53 billion, including a $75 million upfront payment. Based on future net sales, Simcere Zaiming may also be entitled to tiered double-digit royalties. SIM0660 is a tri-specific antibody developed using Simcere Zaiming’s T-cell engager (TCE) multi-specific antibody technology platform. The molecule fuses a CD3-binding T-cell engager arm with binding domains targeting two B-cell antigens, CD79a and CD19, inducing potent T-cell-mediated cytotoxicity while effectively limiting cytokine release. This dual-target strategy has potential ...
- Source: drugdu
- 94
- September 2, 2026
FDA Approves First RAS-Targeted Therapy Rasonque for Pancreatic Cancer, Nearly Doubling Survival | Industry News

On August 26, the U.S. Food and Drug Administration (FDA) approved daraxonrasib for the treatment of pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer in adults. The approval covers patients whose cancer has metastasized to other parts of the body and for whom other treatments have failed. The drug is marketed by Revolution Medicines under the brand name Rasonque. Daraxonrasib is the first targeted therapy approved specifically for pancreatic ductal adenocarcinoma. It inhibits a protein called RAS, which acts like a molecular switch that can become stuck in the “on” position, driving cancer cell growth. Daraxonrasib disables this molecular switch, thereby inhibiting cancer cell growth. More than 90% of pancreatic ductal adenocarcinoma patients carry gene mutations that keep the RAS protein in the “on” state, leading physicians to expect the drug to benefit many patients. The FDA based its approval on clinical trial results presented at the ...
- Source: drugdu
- 95
- September 2, 2026
Baoji Pharmaceutical’s HER2 bispecific antibody KJ015 received FDA approval in the United States, marking a key step in its internationalization strategy.

[Shanghai, China] Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Baoji Pharmaceutical”) recently announced that its Investigational New Drug (IND) application for KJ015, a subcutaneous formulation of a HER2-targeting bispecific antibody, was officially approved by the U.S. Food and Drug Administration (FDA) on August 21, 2026, authorizing it to conduct clinical trials in the United States. This is another significant milestone for KJ015, following its IND approval from the China National Medical Products Administration (NMPA) in December 2024 and the initiation of Phase I clinical trials in China in June 2025 . Powered by universal light chain technology: An antibody achieves dual blockade with Herceptin and Perjeta. KJ015 is an innovative subcutaneous formulation of a bispecific anti-HER2 antibody derived from universal light chain technology. It is designed with two Fab arms containing universal light chains, forming a near-native IgG1 structure. By maintaining high affinity for both epitopes simultaneously, KJ015 ...
- Source: drugdu
- 105
- August 31, 2026
Takeda’s first-ever innovative drug approved for market launch

On August 28, Takeda announced that Rusfertide (trade name: Mimrylo) has been approved by the FDA for the treatment of adult patients with polycythemia vera (PV). Rusfertide is a first-in-class hepcidin analogue , acquired by Takeda from Protector Therapeutics . It is designed to regulate iron distribution and excessive erythrocyte production in the body to control hematocrit (the ratio of red blood cells to total blood volume). The primary treatment goal for PV is to keep hematocrit below 45%. Takeda holds the exclusive global rights to develop and commercialize Rusfertide . This approval is supported by data from the global Phase III VEVERIFY study. This study was a randomized, multicenter, placebo-controlled clinical trial (n=293) designed to evaluate the efficacy and safety of rusfertide (once weekly, subcutaneously) in patients with PV. The primary endpoint of the study was response rate (the proportion of patients who did not require phlebotomy). The results ...
- Source: drugdu
- 105
- August 31, 2026
The FDA has accepted the application for a new indication for Shuwozhe®, for first-line monotherapy in EGFR exon20ins non-small cell lung cancer

On August 30, 2026, Dizhe Pharmaceuticals (stock code: 688192.SH) announced that its self-developed novel lung cancer targeted drug, Shuvozhe® (shuvotinib), has been accepted by the U.S. Food and Drug Administration (FDA) for a new indication marketing application (sNDA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). This application is based on the results of the Phase III international multicenter randomized controlled clinical trial “WU-KONG28”. This study aimed to evaluate the efficacy and safety of Shuwozhe® compared to platinum-based doublet chemotherapy in the first-line treatment of EGFR exon20ins NSCLC. The results showed that Shuwozhe® demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) compared to platinum-based doublet chemotherapy. Detailed data have been presented as a Breakthrough Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) ...
- Source: drugdu
- 95
- August 31, 2026
Eli Lilly’s telpopotamide approved for a new indication!

On August 28 (local time), Lilly announced that its blockbuster drug Tirzepatide (trade name: Mounjaro), a dual agonist of the GLP-1/GIP receptor, has been approved by the FDA for a new indication to reduce the risk of major adverse cardiovascular events (MACE, including CV death, non-fatal myocardial infarction, and non-fatal stroke) in patients with type 2 diabetes. Telpotriol is the first GLP-1R/GIPR agonist approved for this indication. The approval for this indication was based on topline results of cardiovascular outcomes from a head-to-head Phase 3 clinical trial (SURPASS-CVOT) comparing it to Eli Lilly’s GLP-1 receptor agonist Trulicity (dulaglutide, trade name in China: Duyida, approved in China in 2019). The SURPASS-CVOT study (Cardiovascular Outcomes Trial; NCT04255433/CTR20200498, co-led by Beijing Anzhen Hospital affiliated with Capital Medical University and Peking University People’s Hospital in mainland China, with 22 other Chinese hospitals participating) is an event-driven, randomized, double-blind, head-to-head phase 3 trial designed to ...
- Source: drugdu
- 82
- August 31, 2026
Livzon Pharmaceutical Group’s blockbuster Class 1 new drug has been approved for market launch!

With continuous investment in research and development, Livzon Pharmaceutical’s innovative pipeline is steadily delivering on its promises. It is reported that on August 27, the website of the National Medical Products Administration showed that Livzon Pharmaceutical’s Class 1 new drug, Lyconcitazone, was approved for marketing through the priority review and approval process. Lyconchitab is a dual-target inhibitor of IL-17A/F, which simultaneously blocks the interaction between IL-17A/F and its receptor, thereby inhibiting downstream inflammatory signaling pathways. It is indicated for multiple autoimmune and inflammatory diseases. This product has been approved for adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy. The announcement indicates that psoriasis is an inflammatory skin disease prone to relapse, induced by both genetic and environmental factors. There are approximately 125 million patients worldwide, with over 7 million in China, of whom plaque psoriasis accounts for about 80%. It is understood ...
- Source: drugdu
- 86
- August 31, 2026
Haixi’s new drug HX9428 receives Fast Track designation from the US FDA.

Forwarding our company’s announcement dated August 17, 2026: The Board of Directors of our Company is pleased to announce that HX9428, a drug candidate molecule of our independently developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the development of a treatment for neovascular age – related macular degeneration ( nAMD, also known as wet age-related macular degeneration, wAMD) . This FTD designation will facilitate closer communication between our Company and the FDA regarding the clinical development of HX9428 and advance its global clinical development process. HX9428 is a novel oral small molecule drug independently developed by Haixi New Drug, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injection into the eye, which may lead to long-term, repeated treatments, resulting in medical ...
- Source: drugdu
- 208
- August 18, 2026
Just now, Fosun Pharma licensed 10 biosimilar drugs for overseas markets!

Just now, Fosun Pharma issued an announcement stating that its holding subsidiary, Henlius Biotech, signed a “Cooperation Framework Agreement” with Sandoz AG , which will allow Henlius Biotech to cooperate with Sandoz AG on the registration, commercialization, development, and production of up to 10 monoclonal antibody ( mAb ) and / or antibody-drug conjugate ( ADC ) biosimilar products or ingredients in relevant overseas regions . The first three collaborative products are HLX05-N , HLX16 , and belimumab biosimilars, with the collaboration scope covering the treatment of all human indications, but limited to indications approved for the original products in the relevant countries / regions of the collaboration area; one potential collaborative product (options have been granted to the collaborators) is HLXTE-HAase1001 . For the first three collaborative products, Henlius may receive up to US$314 million in upfront payments, development milestones and development budget milestones, and sales milestone payments (subject ...
- Source: drugdu
- 126
- August 18, 2026

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