Trastuzumab Brengitecan

BEIJING, Oct. 22, 2025 /PRNewswire/ -- In October 2025, a partnership between Biokin—a rising star in China's innovative pharmaceutical sector—and global pharmaceutical leader BMS triggered a $250 million milestone payment. This is believed to be the largest antibody-drug conjugate (ADC) milestone payment among hundreds of out-licensing deals involving Chinese innovative drugs. Notably, the overall transaction had previously set a record for the total value of a single-drug asset license in China. Continue Reading iza-bren, a potential first-in-class ADC comprised of an EGFR x HER3 bispecific antibody conjugated In recent years, China's dynamic pharmaceutical ecosystem has rapidly emerged as one of the world's leading sources of novel drug molecules. Such collaborations, however, often come with uncertainties in both China and the U.S. Following the $800 million upfront payment received in early 2024, Biokin's partnership with BMS has advanced smoothly once again. This progress has prompted skeptics to recognize iza-bren's blockbuster potential. The momentum behind the collaboration stems from the continued validation of iza-bren's efficacy. At the 2025 World Congress on Lung Cancer (WCLC), after Dr. Fang Wenfeng presented domestic clinical data, a physician from the prestigious MD Anderson Cancer Center in the U.S. approached him, expressing hope the drug would launch in the U.S. as soon as possible. Such a conversation would have been unimaginable in the past. Despite remarkable progress of China's biopharmaceutical industry over the past decade, nearly all first-in-class new drugs still originate from Western countries. While China has accelerated efforts to bring in overseas innovations, it has also strongly supported domestic pharmaceutical companies and clinical systems in pursuing innovation. Dr. Fang works at the renowned Sun Yat-sen University Cancer Center (SYSUCC), where his team has conducted clinical research on iza-bren for several years. In a study of 50 patients with locally advanced or metastatic EGFR-mutated NSCLC—who had received first-line treatment with other drugs but no chemotherapy—iza-bren controlled tumor progression for over a year, nearly doubling the duration achieved by the current global standard of care. More positive data about iza-bren emerged at the 2025 European Society for Medical Oncology (ESMO) Congress in mid-October. For the first time, results from the pivotal Phase III registration trial of this global first-in-class EGFR×HER3 bispecific ADC were reported: the drug achieved a twofold improvement in key efficacy endpoints in third-line or above treatment for nasopharyngeal carcinoma (NPC). The full study results were published in The Lancet, a leading international medical journal. More than 40 clinical studies of iza-bren are currently underway worldwide, including 10 Phase III registration trials in China and 3 key registration studies overseas. Regulators in China and the U.S. have designated some of these studies as "Breakthrough Therapies" to expedite development. The drug is expected to launch first in China in 2026—three years earlier than its planned U.S. launch—marking a milestone moment for China's innovative pharmaceutical sector. Growing industry consensus on iza-bren's blockbuster potential began at the 2023 ASCO Annual Meeting. At the time, Professor Zhang Li from SYSUCC first reported promising efficacy signals of the drug's Phase I trial. Iza-bren's unique bispecific ADC technology and its ability to target two high-value antigens (EGFR and HER3) have endowed it with strong efficacy and broad applicability. This has attracted multinational pharma giants facing looming patent cliffs and eager to expand their ADC portfolios. BMS reached a global co-development and commercialization agreement with Biokin, the developer of iza-bren, at a potential total value of up to $8.4 billion. Biokin distinguishes itself among China's biotech companies with its unconventional approach. It transitioned from a generic drug manufacturer, and its founder, Zhu Yi, holds no medical degrees from Europe or the U.S., nor has he worked at multinational pharmaceutical companies. Over a decade ago—when the Chinese government first began mapping out the blueprint for its innovative drug ecosystem—Zhu made a firm decision to go all-in on innovative drug R&D. In 2014, amid a global downturn in drug development, he established a lean scientific team in Seattle, U.S., marking the start of his drug R&D journey. Zhu fully leveraged the strengths of both the Chinese and U.S. biopharmaceutical ecosystems: in the U.S., he accessed resources that support early-stage innovation; in China, the efficient regulatory system, large pool of engineers, and abundant patient resources enabled the rapid translation of innovative ideas into reality. Zhu negotiated distinctive terms with BMS: beyond the substantial financial offer, he secured overseas R&D and commercialization rights. He firmly believes the latter is essential for Biokin to truly join the ranks of global pharmaceutical companies. The establishment and progress of this ambitious collaboration model have empowered Biokin to send a strong message for China's biotech industry: to become a multinational company within five years. Beyond iza-bren, Biokin also announced clinical trial results for T-bren, its second ADC drug in Phase III, at the ESMO Congress. Targeting common cancers such as lung, gastric, and breast cancer, T-bren also showed strong signals of becoming a best-in-class drug. Additionally, China's CDE recently approved Biokin's first antibody-radionuclide conjugate (ARC) drug to enter clinical trials. Biokin's story has captured the market's attention. On China's mainland stock exchanges, its market value has surged 15-fold in just over two years. Now, Hong Kong's capital market is embracing the company. Amid the hesitation of onlookers, Biokin may well emerge as a global leader in biopharmaceuticals. SOURCE Biokin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

REDMOND, Wash., Sept. 24, 2025 /PRNewswire/ -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced the presentation of data on iza-bren (izalontamab brengitecan) and BL-M07D1, two distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. Iza-bren, a potentially first-in-class EGFRxHER3 bispecific ADC, is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China. "The breadth of data we are presenting at ESMO this year reflects not only the strength of our ADC platform but also the speed and depth with which we are advancing our clinical pipeline across tumor types," said Dr. Jie D'Elia, Ph.D., Chief Executive Officer of SystImmune. "From our late-stage pivotal trials to our earlier proof-of-concept studies, these achievements demonstrate SystImmune's ability to translate our differentiated ADC platform into potential medicines that have the power to change treatment paradigms for cancer patients worldwide." Key data to be presented at ESMO include: Highlighting the continued clinical advancement of iza-bren: Late-breaking data from the first randomized, open-label, multicenter, Phase III study evaluating iza-bren versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma in China Results from the first Phase 1 study of iza-bren in a global patient population (BL-B01D1-LUNG-101) with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors Safety and efficacy results of iza-bren as a monotherapy in patients with advanced stages of ovarian cancer in China Safety and efficacy results of iza-bren in combination with serplulimab, an anti-PD-1 monoclonal antibody, in patients with extensive-stage small cell lung cancer in China Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1 Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented. "We are excited to present the first randomized data of iza-bren compared to systemic chemotherapy in advanced nasopharyngeal carcinoma demonstrating the clinical benefit of iza-bren for these patients. In addition, the breadth of data being presented at ESMO underscores the potential versatility of iza-bren across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are strongly encouraged by the single-agent activity seen in ovarian cancer and EGFR-mutated NSCLC, as well as the potential for rational combinations observed in small cell lung cancer. These results reinforce our commitment to advancing iza-bren as a therapy that could meaningfully expand treatment options for patients with difficult-to-treat cancers." Details of the presentations at ESMO are below: Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician's Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study Trial Reference: BL-B01D1-303 (NCT06118333), China Session Title: Proffered paper session: Development therapeutics Presentation Number: LBA35 Speaker: Huaqiang Zhou (Guangzhou, China) Session Date & Time: Sunday, October 19th, 2025, 2:45 PM-4:15 PM CEST Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors Trial Reference: BL-B01D1-LUNG-101 (NCT05983432), Global Session Title: Mini oral session: Developmental therapeutics Presentation Number: 921MO Speaker: Helena A. Yu (New York, USA) Session Date & Time: Friday, October 17th, 2025, 4:00 PM-5:30 PM CEST Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) Trial Reference: BL-B01D1-204-01 (NCT06437509), China Session Title: Developmental therapeutics Presentation Number: 934P Speaker: Fei Zhou (Shanghai, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC) Trial Reference: BL-B01D1-202 (NCT05803018, NCT05990803), China Session Title: Developmental therapeutics Presentation Number: 933P Speaker: Wu Yong (Shanghai, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors Trial Reference: CA244-0001 (NCT06618287), Global Session Title: NSCLC, metastatic Presentation Number: 2080eTIP Speaker: Marie Florescu (Montreal, Canada) BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase 1 study Trial Reference: BL-M07D1-101 (NCT05461768), China Session Title: Developmental therapeutics Presentation Number: 935P Speaker: Hong Zong (Zhengzhou, China, Henan) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) Trial Reference: BL-M07D1-101, 102, 202 (NCT05461768, NCT05631964, NCT06031584), China Session Title: Developmental therapeutics Presentation Number: 937P Speaker: Shuqin Ni (Jinan, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST About iza-bren SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death. About BL-M07D1 SystImmune is developing BL-M07D1, an ADC comprising a monoclonal antibody component binding HER2 and a linker-payload component composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. HER2 is highly expressed in multiple solid tumors. BL-M07D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to HER2 on cancer cells. In addition, the binding to HER2 causes its internalization followed by the release of the payload, which then kills the tumor cell. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider. This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements. While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. For additional information about the company, please visit . SOURCE SystImmune, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED