PharmaFocus Today – Page 14 – media

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
- 144
- 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
- 179
- 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
- 226
- 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
- 116
- 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
- 143
- 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
- 248
- 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
- 186
- August 18, 2026
Lunan Pharmaceutical’s Milrinone Lactate Injection Receives Marketing Approval in Malaysia

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Milrinone Lactate Injection issued by the Malaysian Food and Drug Administration ( NPRA ), marking that the product has officially obtained market access in Malaysia and can be sold and commercialized there. Milrinone lactate injection is a phosphodiesterase inhibitor with both positive inotropic and vasodilatory effects. It is a drug that rapidly improves hemodynamics and is suitable for acute and chronic refractory congestive heart failure caused by ineffective or poorly responded treatment with digitalis, diuretics, and vasodilators. Currently, milrinone lactate injection produced by Lunan Pharmaceutical has been approved for marketing in the United States, Ukraine, Costa Rica, and other countries. Furthermore, marketing applications have been submitted in more than 20 countries and regions, including Vietnam, Saudi Arabia, Brazil, and the United Kingdom. During the product’s marketing application process in Malaysia, the ...
- Source: drugdu
- 190
- August 18, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Pakistan.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate (registration number: 135844) for inhaled isoflurane issued by the Drug Regulatory Authority of Pakistan (DRAP) , marking that the product has officially obtained market access in Pakistan and can be sold and commercialized there. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia. With its advantages of rapid induction, rapid recovery, and low metabolic rate , it is widely used in various surgical procedures. Currently, this product is available in China, the United States, and Japan, and registration applications are underway in several overseas markets. The company is accelerating its global supply strategy to provide patients with a safe and effective anesthetic option. During the registration process in Pakistan, the registration team strictly adhered to local regulations, efficiently prepared technical documentation, and communicated with reviewers, leading to the successful ...
- Source: drugdu
- 163
- August 18, 2026
BMS’s new anti-tumor drug has been approved for marketing; GSK and Acyclovir are advancing clinical trials of their new drugs.

On August 13 local time , Bristol Myers Squibb ( BMS ) announced that the U.S. FDA has approved its innovative drug Iberdomide ( Zenbexus ) for marketing in combination with the standard treatment regimen (daratumumab + dexamethasone) for the treatment of relapsed or refractory multiple myeloma ( MM ) . According to the press release, Iberdomide is the first FDA -approved cereblon E3 ubiquitin ligase modulator ( CELMoD ) therapy. Iberdomide is the first product in BMS’ CELMoD pipeline. Previously, the drug received Breakthrough Therapy Designation and Priority Review designation from the FDA for the treatment of relapsed or refractory multiple myeloma. This approval is based on the results of the Phase III EXCALIBER-RRMM ( NCT04975997 ) study . This was a Phase III , multicenter, two-stage, randomized, open-label study designed to evaluate the efficacy and safety of the Iberdomide plus daratumumab and dexamethasone (ZDd) regimen versus the daratumumab, ...
- Source: drugdu
- 202
- August 18, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.