Puma Biotechnology, Inc.

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, November 7, 2024, following the release of its third quarter 2024 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days. 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™-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. Further information about Puma Biotechnology may be found at . Contacts 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

Clermont-Ferrand (France), Tuesday 24 September 2024 (6pm CEST). - CARBIOS, (Euronext Growth Paris : ALCRB), a pioneer in the development and industrialization of biological technologies to reinvent the life cycle of plastic and textiles, and SELENIS, a leading supplier of high-quality specialty polyester solutions, have signed a Letter of Intent (LOI) to cooperate in the production of PETG1. By leveraging CARBIOS’ unique enzymatic depolymerization technology and Selenis’ expertise in polymerization, the companies aim to develop a premium, sustainable PETG material made from PET waste for the Cosmetic and Healthcare packaging sectors across Europe and the U.S. This partnership follows a two-year collaboration between the two companies and represents a significant advancement in the plastic recycling industry. PETG is an indispensable packaging material in both the cosmetics and healthcare industries due to its exceptional clarity, durability, mechanical and chemical resistance. CARBIOS’ enzymatic depolymerization solution breaks down all types of PET waste into PTA2 and MEG3 monomers, which are then transformed into PETG through Selenis’ advanced polymerization processes. Thanks to the purity of these monomers, PETG issued from biorecycling presents the exact same properties as virgin PETG, allowing for products packaged in thick, molded pots and lids to be protected and presented attractively. In the medical and pharmaceutical industries, PETG properties are also critical for guaranteeing top packaging performance, sterility, transparency and optical brightness, making it an ideal choice for complex medical device packaging, pharmaceuticals blisters, or any other packaging of diagnostic equipment. The material’s value is therefore further underscored by combining a sustainable recycling solution whilst guaranteeing all needed properties, aligning with consumer sustainability demands and stringent regulatory requirements. CARBIOS and Selenis’ partnership is the result of extensive pilot and industrial polymerization trials that have refined the quality of the end product. The result is high-specialty PETG grades issued from biorecycling that meet the strict requirements of sectors like cosmetics and healthcare, where Selenis has a strong presence through its Selcare brand. Emmanuel Ladent, CEO, CARBIOS: “CARBIOS and Selenis have a long collaboration, and we are pleased to build on this established relationship to produce PETG issued from CARBIOS’ unique biorecycling technology. This high-specialty, premium material meets demanding quality requirements whilst also contributing to the transition to more sustainable packaging materials. The partnership will open new markets for CARBIOS, notably the healthcare sector, as we continue our worldwide commercial deployment.” Eduardo Santos, Head of Corporate Strategy at Selenis: “This collaboration marks an exciting step in our mission to drive sustainability in the polymerization industry. By combining our 65 years of expertise with CARBIOS’ pioneering biorecycling technology that ensures high-quality monomers for the production of virgin-like PETG, we are advancing in the development of sustainable materials to meet the growing demand for environmentally responsible solutions in the cosmetic and healthcare sectors. Together, we have the potential to reshape the future of sustainable plastics." ### About CARBIOS: CARBIOS is a biotech company developing and industrializing biological solutions to reinvent the life cycle of plastic and textiles. Inspired by nature, CARBIOS develops enzyme-based processes to break down plastic with a mission to avoid plastic and textile pollution, and accelerate the transition to a circular economy. Its two disruptive technologies for the biorecycling of PET and the biodegradation of PLA are reaching industrial and commercial scale. Its biorecycling demonstration plant has been operational since 2021 and a first industrial plant, in partnership with Indorama Ventures, is currently under construction. CARBIOS, founded in 2011 by Truffle Capital, has received scientific recognition, notably with the cover of Nature, and is supported by prestigious brands in the cosmetics, Food & Beverage and apparel industries to enhance their products’ recyclability and circularity. Nestlé Waters, PepsiCo and Suntory Beverage & Food Europe are members of a packaging consortium founded by CARBIOS and L’Oréal. On, Patagonia, PUMA, PVH Corp. and Salomon collaborate with CARBIOS in a textile consortium. Visit www.carbios.com/en to find out more about biotechnology powering plastic and textile circularity. For latest news and media assets, visit our newsroom: www.carbios.com/newsroom/en/ LinkedIn: CARBIOS / Instagram: insidecarbios Information on CARBIOS shares: ISIN Code:FR0011648716Ticker Code:Euronext Growth: ALCRBLEI:969500M2RCIWO4NO5F08 CARBIOS is eligible for the PEA-PME, a government program allowing French residents investing in SMEs to benefit from income tax rebates. About Selenis Selenis is a supplier of high quality and innovative specialty polyester solutions for diverse applications. Their mission relies on employing their profound knowledge of polymers, formulations, and processing, in partnership with their clients to develop future-fit solutions and commit to create opportunities. Selenis is a global business with production sites in Portugal, Italy and the USA. Their production facilities have batch and continuous SSP units, permitting the production of a wide range of polymers to meet highly technical markets. Their production configurations provides Selenis the flexibility to produce both amorphous and crystallised products. Committed to playing a role in society’s collective response to the plastic waste challenge, Selenis creates partnerships across the value chain to create long term solutions. Highly focused on sustainability, Selenis centers their innovation in developing resins with up to 50% recycled content and solutions that are fully recyclable in the PET stream. Their progress in molecular recycling turns waste into the building blocks of their specialty resins, contributing to the fight against climate change. Selenis and their sister company, Evertis, are members of the IMG group, an international business headquartered in Portugal with operations around the world. Our businesses have been pioneers in the polyester industry since 1959. To discover more, please visit our website at www.selenis.com Follow Selenis on LinkedIn About Selcare Selcare is a brand of Selenis, producer of specialty resins for a diverse range of medical applications. Selenis is a member of the IMG Group, present in the polymers market since 1959. Selenis aspires to improve patient safety with solutions specifically developed for the medical value chain. Our Selcare brand offers high performing medical grade plastics and a wide range of supporting services. For additional information, please contact: CARBIOSPR USPR DACH & UKSELENIS Melissa FlauraudRooney PartnersMC ServicesMarketing & Communications Press RelationsKate L. BarretteAnne-HenneckeRocío Arranz melissa.flauraud@carbios.comkbarrette@rooneyco.comcarbios@mc-services.eumarketing@selenis.com +33 (0)6 30 26 50 04+1 212 223 0561+49 (0)211 529 252 22+34 672 624 400 1 Polyethylene terephthalate glycol2 purified terephthalic acid3 monoethylene glycol Attachments PR_2024 09 24_CARBIOS_SELENIS_EN_FINAL CARBIOS - PET Biorecycling - PTA Aerial view of Selenis’ industrial plant in Portalegre, Portugal CARBIOS - PET Biorecycling - MEG

近日，辉瑞和阿斯利康（AZ）持续多年的专利战，终于落幕。据路透社报道，美国特拉华州联邦法官驳回了陪审团就“阿斯利康Tagrisso（奥希替尼）因侵犯辉瑞的抗癌药物Nerlynx（奈拉替尼）专利而赔偿1.075亿美元”的裁决，法官Matthew Kennelly认为辉瑞指控阿斯利康畅销肺癌药物Tagrisso侵犯其两项专利无效。 结果反转的专利战 奈拉替尼是一款表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），可以与EGFR（HER1）、HER2 和 HER4不可逆结合，抑制受体的磷酸化，进而阻断下游信号传导。最终可以抑制癌细胞的增殖、存活、迁移等并改善肿瘤微环境。 2009年，辉瑞以680亿美元收购惠氏，将奈拉替尼收入囊中。2011年，Puma Biotechnology从辉瑞获得了奈拉替尼的授权，并全权负责该药物的全球开发和商业化。 2017年7月，奈拉替尼被FDA批准上市，用于降低早期HER2阳性乳腺癌复发风险。2020年， FDA批准奈拉替尼联合卡培他滨用于既往使用过两种以上晚期或转移性 HER2 阳性乳腺癌成人患者。随着这项适应症的获批，奈拉替尼不仅仅可以适用于早期乳腺癌患者，也可以适用于晚期或转移性乳腺癌患者。 奥希替尼是阿斯利康开发的一种第三代EGFR-TKI，2015年11月获FDA批准上市，用于T790M基因突变阳性（T790M+）NSCLC患者二线治疗，目前已在NSCLC领域获批多项适应症。作为上市的第三代EGFR-TKI，奥希替尼的销售额不断刷新记录，2023年达到57.99亿美元，是阿斯利康的当家花旦。 2021年，辉瑞子公司惠氏和Puma Biotechnology开始起诉阿斯利康，指控奥希替尼侵犯其两项关键专利，分别为：“314专利”，涉及用一种与蛋白质半胱氨酸773残基共价结合的EGFR阻断剂治疗对吉非替尼（gefitinib）和/或厄洛替尼（erlotinib）耐药的NSCLC患者的方法。 另一项是惠氏的“162专利”，该专利保护使用这些不可逆抑制剂治疗对吉非替尼或厄洛替尼耐药的、携带EGFR蛋白上特定T790M突变的NSCLC患者。 2023年5月，特拉华联邦陪审团裁定，阿斯利康确实侵犯了辉瑞的专利，同时将赔偿的金额定为1.075亿美元。虽然阿斯利康提出了辉瑞专利无效的论点，但陪审团们并未有所动摇。对此结果，阿斯利康提出“额外辩护”。 在这次最新裁决中，法官认为辉瑞指控奥希替尼侵犯其两项专利无效。因为这些专利缺乏对其发明的有效书面描述，并且该领域的普通科学家无法重新创造它们。 阿斯利康最终在这场专利战中赢得了反转，取得胜利。但对于奥希替尼来说，则面临着诸多挑战。 EGFR-TKI：大市场 强竞争 目前，肺癌是全球第二大常见癌症，据世界卫生组织国际癌症研究机构（IARC）的数据，2020年，全球肺癌占全部癌症种类的11.1%。肺癌患者中85%为NSCLC，其余15%为小细胞肺癌（SCLC）。EGFR是NSCLC最重要的致癌驱动基因之一，研究显示，EGFR突变在全球转移性NSCLC患者中发生率为30%。中国NSCLC患者中EGFR突变占比约51%。 EGFR-TKI为EGFR突变NSCLC患者的标准疗法。 截至目前，全球已有三代EGFR-TKI产品获批。其中第一、二代EGFR-TKI主要用于EGFR19外显子缺失突变（EGFR ex19del）和21外显子L858R突变（EGFR 21L858R）患者，第三代药物除了用于敏感突变以外，对第一、二代TKI获得性耐药产生的T790M突变同样有效。 作为获批上市的EGFR-TKI，奥希替尼上市后销量一直创新高，成为阿斯利康的业绩支柱。不过第三代EGFR-TKI市场虽然巨大，但竞争也十分激烈，全球已获批7款同类产品，国内已批准6款。 另外奥希替尼国内化合物专利CN103702990将于2032年7月到期，作为国内进口抗癌药中市场潜力巨大的产品，目前国内江苏万邦生化医药集团的奥希替尼仿制药，已以仿制4类递交上市申请，并成功获批。 在创新药方面，国内江苏豪森药业的阿美替尼、艾力斯医药的伏美替尼均已获NMPA批准上市。此外，奥赛康的limertinib、强生的兰泽替尼、同源康医药的TY-9591、艾森医药的艾维替尼等，已在国内提交上市申请或进入III期临床阶段。 除了同类产品的竞争，奥希替尼还面临双抗等的围攻。近日，强生的EGFR/C-MET双抗Amivantamab联合第3代EGFR-TKI拉泽替尼（A+L），在与奥希替尼单药用于EGFR+晚期NSCLC一线治疗的头对头临床试验中，达到了PFS终点。结果显示，与奥希替尼相比，A+L组显著降低30% PFS风险 (HR, 0.70; 95% CI, 0.58–0.85; P<0.001)，mPFS达23.7个月（vs 16.6个月），ORR达86%（vs 85%)。OS方面，A+L组中位OS无法估计（HR，0.77），奥希替尼组为37.3个月(HR, 0.77)。OS达到统计学有效终点。A+L有可能成为一线治疗EGFR+ NSCLC的新标准。 在仿制药和创新药的围攻下，阿斯利康的奥希替尼正面临激烈竞争。无论如何，此次专利战的胜利，为阿斯利康省下了1.07亿美元的赔偿金。 参考来源：        1、https://www.fiercepharma.com        2、Xuhong JC,Qi XW,Zhang Y,et al.Mechanism, safety and efficacy of three tyrosine kinase inhibitors lapatinib, neratinib and pyrotinib in HER2-positive breast cancer.[J].Am J Cancer Res,2019,10:2103-2119.        3、CDE官网 药渡媒体商务合作 媒体公关 | 新闻&会议发稿 张经理：18600036371（微信同号） 点击下方“药渡“，关注更多精彩内容 免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇