Aurora A

This collaboration will provide early-stage HER2-positive breast cancer patients with access to the targeted therapy that can reduce the risk of cancer recurrence and spread ATHENS, Greece and LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies in the EMEA region, today announced that it has signed an agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) to commercialize NERLYNX® (neratinib) in select countries in Eastern Europe and Central Asia. NERLYNX is designed to block human epidermal growth factor receptor 2 (HER2) in order to treat and limit breast cancer metastasis. Under the agreement, Er-Kim is appointed as the distribution partner for NERLYNX in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan. NERLYNX is a prescription medicine used alone to treat adults with early-stage HER2-positive breast cancer and who have previously been treated with trastuzumab-based therapy. NERLYNX is also approved for use with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer. According to the International Agency for Research on Cancer (IARC), globally, breast cancer is the most common cancer type among women and the second most common cancer type overall. An estimated 2.3 million new breast cancer cases and 670,000 breast cancer-related deaths occurred worldwide in 2022. However, the burden of breast cancer is not evenly distributed across different world regions. “While breast cancer affects individuals globally, treatment availability varies considerably across regions,” said Cem Zorlular, Chief Executive Officer of Er-Kim. “That is why we are pleased to be working with Puma Biotechnology to support access to NERLYNX in Russia and most of the Commonwealth of Independent States (CIS) for patients with early-stage breast cancer. Er-Kim has a long history of providing treatments in the EMEA region, particularly in women's health.” About Er-Kim Established in 1981, Er-Kim stands at the forefront of biopharmaceutical innovation, partnering with over 40 global leaders to revolutionize patient care in key international markets. Our pioneering business models, tailored for sustainability and flexibility, have positioned us as a full-service solution, extending our reach to over 600 million patients through our fully owned affiliates. With a dedicated team of over 280 professionals worldwide and revenues exceeding EUR 260M, Er-Kim is not just a partner but a trailblazer in healthcare, continually setting new standards in commercialization and patient access. For more information, please visit http://www.er-kim.com/. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early- stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Media contact: Rosalia ScampoliMarketcom PRTel: (914) 815-1465rscampoli@marketcompr.com

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that clinical data on neratinib were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting is currently taking place at the McCormick Place in Chicago, Illinois. The poster is entitled, “CT071: Phase I trial of trastuzumab deruxtecan in combination with neratinib in solid tumors with HER2 alterations (NCI 10495).” Andrew A. Davis, Assistant Professor at Washington University School of Medicine, presented the poster during Session PO.CT01.01 – First-in-Human Phase I Clinical Trials 1. NCI 10495 is sponsored by the National Cancer Institute, part of National Institutes of Health, and conducted in the NCI funded Experimental Therapeutics Clinical Trials Network (ETCTN). This open label, multi-center, Phase I clinical trial (NCT05372614) enrolled 20 patients in three cohorts treated with three increasing dose levels, or a 3+3 trial design, to evaluate the safety and tolerability of trastuzumab deruxtecan (T-DXd or ENHERTU®) in combination with neratinib (NERLYNX®). Eligible patients had advanced solid tumors with HER2 immunohistochemistry 3+ (IHC3+), HER2 amplification identified by in situ hybridization or next-generation sequencing, or an activating HER2 mutation. Prior treatment with trastuzumab deruxtecan was not allowed. The dose of trastuzumab deruxtecan was fixed at 5.4 mg/kg. The three dose levels (DLs) for neratinib all started at 120 mg daily for the first week. DL1 remained at 120 mg daily throughout the course of treatment, DL2 escalated to 160 mg daily in week 2 and 200 mg by week 3, and DL3 escalated to 160 mg in week 2 and 240 mg by week 3. The primary endpoints were the determination of the dose-limiting toxicities (DLTs) during the first two cycles of treatment (42 days) and the determination of the recommended Phase II dose of the combination of trastuzumab deruxtecan and neratinib. Twenty patients received study treatment (DL1 N=7, DL2 N=4, and DL3 N=9). The most common treatment-emergent adverse events of any grade included nausea (N=15, 75%), diarrhea (N=15, 75%), fatigue (N=13, 65%), and hypokalemia (N=11, 55%). Grade 3 treatment-emergent adverse events that occurred in more than 2 patients included anemia (N=6, 30%), diarrhea (N=4, 20%), and hypokalemia (N=3, 15%). The only Grade 4 treatment-related adverse event was neutropenia that occurred in 1 patient (5%). One DLT (acute kidney injury) was observed at DL1, 0 DLTs were observed in DL2, and 1 DLT was observed (fatigue leading to early drug discontinuation) at DL3. Three patients developed Grade 1 pneumonitis or interstitial lung disease (ILD), 2 at DL1 and 1 at DL3. The proportion of reported treatment-emergent adverse events was lower at higher dose levels. Of 15 response-evaluable patients by RECIST v1.1, 4 patients had a partial response (PR), including patients with gastroesophageal (N=2, one HER2 IHC 3+ and one HER2 mutated), pancreatic (N=1, IHC 3+), and ovarian (N=1, IHC 3+; unconfirmed response) cancers. Notably, 3 of 5 patients with advanced pancreatic cancer were observed to have tumor regression (1 PR for 13+ cycles, 2 with stable disease consisting of one patient with -29.4% tumor regression for 9 cycles and one patient with -13.3% tumor regression for 8 cycles). Dose level 3, which consisted of trastuzumab deruxtecan at 5.4 mg/kg and neratinib at 120 mg in week 1, 160 mg week 2, and 240 mg week 3 onward, was selected as the recommended Phase II dose. Part 2 of this study, which consists of a pharmacodynamic evaluation of trastuzumab deruxtecan (5.4 mg/kg) and neratinib (RPD2) in 12 patients, opened to enrollment in March 2025. Patients with any advanced solid tumor and HER2 amplification/overexpression or a HER2 mutation will be enrolled. “Neratinib and trastuzumab deruxtecan showed impressive combination activity in preclinical models of HER2-mutated breast cancers, which prompted evaluation of the combination in this first-in-human clinical trial. I am pleased to report that the combination not only had a manageable safety profile, but we also observed early signs of efficacy across a variety of HER2-altered tumors,” said Dr. Davis. Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, added, “We are pleased with the tolerability and potentially promising signals of efficacy of neratinib in combination with trastuzumab deruxtecan, especially in hard-to-treat tumors including pancreatic cancer. We look forward to continued evaluation of this combination in the Phase II portion of this study.” NCI 10495 is also supported by Puma Biotechnology and Daiichi Sankyo, Inc. through Cooperative Research and Development Agreements with NCI. Trastuzumab deruxtecan is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull or Olipriya Das, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com olipriya.das@russopartnersllc.com

北京、上海和波士顿 2025年3月19日 /美通社/ -- 加科思药业（1167.HK）发布2024全年业绩报告，业绩期内营业收入1.6亿，研发费用3.3亿元。主要经营及融资资金流入3.2亿元，资金及银行授信余额14.5亿。加科思同时公布了近期业务进展及预期里程碑事件。 "2024年是加科思的变革之年，加科思提交了KRAS G12C抑制剂戈来雷塞提交新药上市申请，并达成后续临床试验及商业化的授权合作，这标志着加科思成功跨越早期研发阶段，进入创新驱动的价值兑现期，"加科思药业董事长兼CEO王印祥博士表示："展望2025年，戈来雷塞预计将正式获批上市，这将为加科思后续管线奠定现金流基础。" 临床项目加速推进 戈来雷塞（JAB-21822，KRAS G12C抑制剂）与sitneprotafib（JAB-3312，SHP2抑制剂） 戈来雷塞与Sitneprotafib在中国的商业化及进一步临床开发已于2024年8月30日与艾力斯达成授权合作 非小细胞肺癌 戈来雷塞单药治疗二线及以上非小细胞肺癌适应症已于2024年5月提交新药上市申请，并获得优先审评资格，预计将于2025年上半年在国内获批 戈来雷塞与sitneprotafib联用治疗一线非小细胞肺癌的三期试验已于2024年8月7日在中国完成首例患者入组 泛癌种 戈来雷塞单药治疗包括胰腺癌、胆道癌、胃癌、小肠癌、阑尾癌等适应症在内的泛癌种注册性临床试验已在中国展开。戈来雷塞胰腺癌适应症在美国和欧洲获得孤儿药认定（ODD） 结直肠癌 戈来雷塞单药或联合西妥昔单抗治疗三线及以上的KRAS G12C突变的结直肠癌症患者的三期试验已于2024年5月获CDE批准 JAB-23E73 （泛KRAS抑制剂） 2024年9月在中美获批新药临床试验申请（IND） 首例患者于2024年11月入组 预计于2025年下半年完成剂量递增试验 JAB-30355 （p53 Y220C激活剂） 分别于2024年3月及6月在美国和中国获批临床试验 首例患者于2024年7月入组 剂量递增试验预计于2025年下半年完成 JAB-8263 （BET抑制剂） 在中国和美国完成实体瘤和血液瘤的剂量递增试验，获得二期推荐剂量 骨髓纤维化剂量拓展试验正在进行中 目前正在探索具有特定生物标志物的实体肿瘤 JAB-2485 （Aurora A抑制剂） 全球I/IIa期试验正在中美进行 剂量递增试验将于2025年上半年完成 计划扩展单药及与化疗的联合疗法 积极布局临床前项目 JAB-BX467 （HER2-STING iADC） 于2024年提名HER2-STING iADC临床候选化合物 计划于2025年开展IND-enabling相关工作，2026年提交IND JAB-BX600 （KRAS G12D ADC） 计划于2025年下半年提名候选化合物 截至2024年12月31日，加科思全球发明专利申请累计360余件，其中授权发明专利126件。 电话会议相关信息 加科思药业将于北京时间2024年3月20日9:30-10:30召开2024年度业绩电话会。如需参加，请由此链接提前注册： https://s.comein.cn/hdqi2zrx 关于加科思药业 加科思药业（1167.HK）致力于为患者提供突破性治疗方案。加科思拥有诱导变构药物发现平台，核心项目围绕KRAS通路布局。公司愿景是与合作伙伴携手共进，成为全球认可的药物研发领导者。实验室位于中国北京、上海和美国波士顿，临床试验覆盖中国180余家、美国30余家、欧洲多国的十余个临床研究中心及临床科室。了解更多，请访问： www.jacobiopharma.com