Glepaglutide

Company announcement - No. 39 / 2024 Zealand Pharma Announces Financial Results for the First Half of 2024 Very strong progress across R&D pipeline followed by substantial capital raise enabling further investments to accelerate the development programs for wholly owned obesity assets. Extremely encouraging weight loss and tolerability data announced with long-acting amylin analog petrelintide from MAD Part 2 (16-week trial)Impressive data from Boehringer Ingelheim’s Phase 2 clinical trial with survodutide in MASH presented at the EASL congress in Milan, ItalySignificant strengthening of the balance sheet with completion of upsized equity offering raising gross proceeds of DKK 7 billion / USD 1 billion, which enables further investments to accelerate the development of our differentiated obesity assets resulting in a guidance update of net operating expenses to DKK 1.25 – 1.35 billion for 2024 Copenhagen, Denmark, August 15, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the interim report for the six months ended June 30, 2024, and provided a corporate update. Phenomenal first half of 2024 with impressive data in obesity followed by one of the strongest ever capital raises in EuropeAdam Steensberg, President and Chief Executive Officer at Zealand Pharma said:“I am very pleased with our progress in the first six months of 2024 that included impressive data across the obesity portfolio. In particular, the 16-week data with petrelintide reaffirmed our conviction in our amylin analog as an alternative to GLP-1RA-based therapies with potential to become the future backbone therapy for weight management. Looking into the second half of the year, we have an important data read-out for dapiglutide and potential approvals in the US for both our rare disease programs. Backed by a very solid financial position following the extraordinary capital raise in June, we are investing significantly in our differentiated obesity candidates to accelerate the development programs as we explore partnership opportunities.” Key financial results for H1 2024 DKK millionH1 2024H1 2023Revenue49.224.0Net operating expenses1-558.7-388.1Net operating result-523.5-364.0Net financial items-0.5-152.3 DKK millionJun-30, 2024Dec-31, 2023Cash position29,747.71,633.1 Notes:1. Net operating expenses consist of R&D, S&M, G&A and other operating items.2. Cash position includes cash, cash equivalents and marketable securities. Revolving Credit Facility is not included. Highlights in the second quarter 2024Obesity Petrelintide, amylin analog: Reported positive topline data from the 16-week multiple ascending dose (MAD) trial, Part 2 of the Phase 1b trial. Topline results showed mean body weight reductions of up to 8.6% after 16 weeks with once-weekly dosing of petrelintide using a dose escalation scheme, versus 1.7% mean body weight reduction for the pooled placebo group. 79% of the 48 trial participants were male and median BMI was 29 kg/m2. Petrelintide was very well tolerated, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild, except for two moderate events (nausea and vomiting) reported in one participant who discontinued treatment. No other trial participants discontinued treatment due to AEs. No other events of vomiting occurred, and two events of diarrhea were reported, both of which were mild.Dapiglutide, GLP-1/GLP-2 receptor dual agonist: Reported topline data from the mechanistic investigator-led trial DREAM with low doses of dapiglutide. Topline results showed mean weight loss of up to 4.3% after 12 weeks with low doses of dapiglutide treatment. Dapiglutide was assessed to be well tolerated, with no treatment emergent adverse events (TEAEs) leading to treatment discontinuation and fewer GI TEAEs compared to what have been reported from other trials with incretin-based therapies, suggesting that doses of dapiglutide investigated were at the lower end of the therapeutic range in an obesity setting. Higher doses of dapiglutide are being investigated in the ongoing Phase 1b trial, with topline results from Part 1 of the trial exploring doses of dapiglutide up to 13 mg over 13 weeks of treatment expected in the second half of 2024. Additional data from DREAM on cardiovascular risk, systemic inflammatory markers, as well as data from gut biopsies, will be presented at a future scientific meeting. MASH Survodutide, glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim presented breakthrough results at the EASL congress from Phase 2 trial in MASH. The detailed results showed that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved a biopsy-proven improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks of survodutide treatment, versus 25.8% with placebo. Survodutide demonstrated safety data consistent with GLP-1RA-based molecules, with no new safety data concerns. Boehringer Ingelheim confirmed that survodutide will advance into Phase 3 for the potential treatment of MASH. Financial Solid financial position. Completed an upsized equity offering of 8.35 million new ordinary shares raising gross proceeds of USD 1 billion / DKK 7 billion representing one of the strongest ever capital raises in Europe. The net proceeds will support the advancement of Zealand’s proprietary obesity programs in Phase 2b clinical trials and beyond, including investments in associated CMC activities and additional clinical development activities in related indications. The net proceeds will also support continued early-stage research and fund general corporate purposes. Events after the reporting dateType 1 diabetes Zegalogue® (dasiglucagon injection for severe hypoglycemia) approval in the EU. The European Commission granted marketing authorization for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents and children aged six years or older with diabetes in Europe under the brand name Zegalogue®. Zegalogue® is licensed to Novo Nordisk who is responsible for commercialization worldwide. Corporate Appointed Eric Cox as Chief Commercial Officer. Eric will lead Zealand’s commercial strategy and assume responsibility for business development. Financial Terminated the Revolving Credit Facility provided by Danske Bank. The Revolving Credit Facility of DKK 350 million provided by Danske Bank was terminated in July 2024 following the equity offering in June 2024 that resulted in a cash position of DKK 9.7 billion as of June 30, 2024. Upcoming events in 2024Obesity Petrelintide, amylin analog. Detailed results from Part 2 of the MAD trial to be presented at a scientific congress in the coming months. In the second half of 2024, Zealand expects to initiate the Phase 2b program with petrelintide in people with overweight or obesity.Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second half of 2024, Zealand expects to report topline results from Part 1 of the Phase 1b dose titration trial, evaluating doses of dapiglutide treatment up to 13 mg and thus significantly higher doses compared to the prior 4-week MAD trial and the investigator-led trial DREAM. Based on the tolerability profile observed to date, a cohort (Part 2 of the Phase 1b trial) evaluating even higher doses up to 26 mg and with 28 weeks of treatment has been added, with topline results expected in the first half of 2025. The added cohort will have no impact on the expected timing for initiation of a Phase 2b trial in the first half of 2025.Survodutide in MASH. In the second half of 2024, Boehringer Ingelheim is expected to initiate the Phase 3 program with survodutide in MASH. The Phase 3 program with survodutide in obesity, SYNCHRONIZETM, was initiated in 2023. Rare diseases Glepaglutide in SBS. US FDA has set a Prescription Drug User Fee Act (PDUFA) date on December 22, 2024. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization.Dasiglucagon in CHI. US FDA has set a PDUFA date on October 8, 2024 for Part 1 of the NDA review related to dosing of up to three weeks. For Part 2 of the NDA review, which relates to use beyond three weeks, the US FDA requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which Zealand expects to submit in the second half of 2024. CGM was included as a secondary outcome measure in the Phase 3 program. Zealand is engaging in partnership discussions for future commercialization of the product. In parallel, Zealand intends to make the product available to patients in the US contingent on an approval by the FDA in October 2024 for up to three weeks of dosing. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024. Financial guidance for 2024 Following the capital raise in June 2024, our significantly strengthened cash position provides a unique opportunity to accelerate the development programs of our differentiated obesity assets.Guidance updated compared to February 27, 2024 DKK million2024 Guidance(15 August)2024 Guidance(27 February)Revenue anticipated from existing and new license and partnership agreementsNo guidance due to uncertain size and timingNo guidance due to uncertain size and timingNet operating expenses31,250-1,3501,100-1,200 Notes:3. Financial guidance based on foreign exchange rates as of August 15, 2024. Conference call today at 2 PM CET / 8 AM ETZealand’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first six months of 2024 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI317d27d63df44f09bded2febfbe6b52a. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/ya97oe47. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand’s website at https://www.zealandpharma.com/events/. Financial Calendar for 2024Q3 2024 November 7, 2024 About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com. Forward-looking StatementsThis company announcement and interim report contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom and the company’s Upcoming Events and Financial Guidance for 2023. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Zealand Pharma® is a registered trademark of Zealand Pharma A/S. Contacts:Adam LangeInvestor Relations OfficerZealand PharmaEmail: ALange@zealandpharma.com Anna Krassowska, PhDVice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: AKrassowska@zealandpharma.com Attachment Zealand Pharma H1 2024 Company Announcement_vFinal

▎药明康德内容团队编辑 根据PDUFA的预期目标日期，预计8月，美国FDA将对9款创新药物的批准做出监管决定，本文将对这些疗法进行相关介绍。 ▲8月有望在美国获批的新药（药明康德内容团队制图，点击可见大图） 活性成分：Afamitresgene autoleucel（afami-cel） 适应症：滑膜肉瘤 公司名称：Adaptimune Therapeutics Afami-cel是一种针对MAGE A4癌症靶点的工程化T细胞受体（TCR）T细胞疗法，被设计作为一种用于晚期滑膜肉瘤的一次性疗法。此前，美国FDA已授予其治疗软组织肉瘤的孤儿药资格和治疗滑膜肉瘤的再生医学先进疗法认定。根据新闻稿，如果获得批准，afami-cel将成为首款用于治疗实体瘤的工程化T细胞疗法，也是十多年来治疗滑膜肉瘤的首个有效疗法。 该疗法上市申请的递交主要是基于一项关键性研究SPEARHEAD-1中队列1的积极数据。该研究达到了主要疗效终点，患者的总缓解率（ORR）约为39%，中位缓解持续时间约为12个月。以往接受过两种或两种以上疗法的滑膜肉瘤患者的中位总生存期（OS）小于12个月，而接受afami-cel治疗患者的中位OS约为17个月，优于历史对照数据。接受afami-cel治疗有缓解的晚期滑膜肉瘤患者中，70%的人在治疗两年后仍然存活。其他分析表明，较高的afami-cel细胞持久性与较长的OS有关。 活性成分：Nemolizumab 适应症：结节性痒疹 公司名称：Galderma、Chugai Pharmaceutical Nemolizumab是一种”first-in-class”单克隆抗体，它通过与IL-31受体α相结合，可以阻断IL-31的信号通路。IL-31是导致严重瘙痒的重要细胞因子。 结节性痒疹是一种炎症性皮肤病，其主要特征包括全身大面积的毁容性皮肤结节，以及剧烈的慢性皮肤瘙痒。之前公布的试验结果显示，38%接受nemolizumab治疗的中重度结节性痒疹患者的皮损得到完全或基本清除，而安慰剂对照组中这一比例仅为11%；56%的患者在接受nemolizumab治疗后瘙痒症状得到缓解，表现为PP-NRS瘙痒数值评定量表得分降低了至少4分，安慰剂对照组中仅有21%的患者报告瘙痒症状的缓解（P<0.0001)。 活性成分：Palopegteriparatide 适应症：甲状旁腺功能减退症 公司名称：Ascendis Pharma Palopegteriparatide是一种甲状旁腺激素（PTH）前药，它旨在每天将PTH恢复至生理水平24小时，以解决甲状旁腺功能减退的短期症状和长期并发症。甲状旁腺功能减退症是一种罕见的内分泌疾病，其特征是PTH水平不足，导致血液中低钙和磷酸盐水平升高。大多数患者在甲状腺手术期间损伤，或意外切除甲状旁腺后发生此疾病。 之前所公布的随机双盲、含安慰剂对照的3期临床试验中，共有82位慢性甲状旁腺功能减退成人患者入组。结果显示，接受palopegteriparatide治疗的患者中，78.7%的患者实现不依赖常规治疗，保持血清钙水平在正常范围内（8.3–10.6 mg/dL），在安慰剂组此数值仅有4.8%（p<0.0001）。此外，通过甲状旁腺功能减退患者体验量表（HPES）检测的患者身体症状和认知症状，均获得统计学显著减少。 活性成分：Seladelpar 适应症：原发性胆汁性肝硬化（PBC） 公司名称：吉利德科学（Gilead Sciences） Seladelpar为一款在研、口服、潜在“first-in-class”的强效选择性过氧化物酶体增殖物活化受体δ（PPARδ）激动剂。PPARδ表达在肝脏的多种细胞类型中，临床前数据表明，它对调控胆汁酸合成、炎症、纤维化过程的多种基因有调节作用。该药物曾于2019年2月获得美国FDA授予突破性疗法认定，用以治疗PBC。 PBC是一种有潜在生命危险的肝脏自身免疫性疾病。由于免疫系统持续攻击胆管，胆汁流动受阻而淤积，毒性胆汁酸在肝内留存，可发展为肝纤维化、肝硬化和肝功能衰竭。今年6月初所公布的3期研究分析显示，接受seladelpar治疗的中度至重度PBC成人患者中，患者报告的瘙痒迅速且持久地减少。针对代偿性肝硬化受试者的亚群分析表明，这类患者的胆汁淤积和肝损伤标志物有临床意义的改善。 活性成分：Vorasidenib 适应症：IDH突变神经胶质瘤 公司名称：Servier Vorasidenib是一款口服、具脑渗透性与选择性的在研双重抑制剂，可抑制突变的IDH1/2蛋白，为潜在“first-in-class”药物。该疗法曾获得美国FDA授予突破性疗法认定。 Vorasidenib上市申请的递交主要是基于INDIGO关键3期临床试验的结果，该试验在第二次预定中期分析时达到了盲法独立审评委员会（BIRC）所评估的无进展生存期（PFS）主要终点和下次干预时间（TTNI）的关键次要终点。由BIRC评估的PFS分析显示，vorasidenib组和安慰剂组患者的PFS分别为27.7个月和11.1个月，试验达主要终点，两者差异具有统计学显著性和临床意义（HR=0.39；95% CI：0.27-0.56；单侧P=0.000000067）。 活性成分：Linvoseltamab 适应症：多发性骨髓瘤 公司名称：再生元（Regeneron Pharmaceuticals） Linvoseltamab是一种在研BCMA x CD3靶向双特异性抗体，旨在将多发性骨髓瘤细胞上的BCMA与表达CD3的T细胞桥接，以促进T细胞活化和癌细胞杀伤。Linvoseltamab已被美国FDA授予快速通道资格用以治疗多发性骨髓瘤。 Linvoseltamab的上市申请主要基于关键性1/2期临床试验LINKER-MM1的结果。去年12月公布的数据显示，在中位随访时间为11个月时，在1/2期临床试验中（n=117），接受200 mg剂量linvoseltamab治疗的患者中观察到的客观缓解率为71%，其中46%患者达到了完全缓解或更好的效果。 活性成分：Glepaglutide 适应症：短肠综合征（SBS） 公司名称：Zealand Pharma Glepaglutide是一种长效GLP-2类似物，该疗法设计为一种装于自动注射器中的液体产品，设计用于每周两次的皮下给药，旨在减少或消除SBS患者对肠外支持的需求。美国FDA已授予该疗法治疗SBS的孤儿药资格。 随机双盲关键3期试验EASE-1的分析结果显示，与安慰剂相比，每周两次皮下给药10 mg glepaglutide在第24周显著降低患者每周肠外营养支持（PS）所需总体积（P=0.0039）。第24周时，每周两次接受glepaglutide治疗患者的PS较基线平均降低5.13公升/周。安慰剂治疗仅导致所需PS液体体积降低2.85公升/周。对于接受每周两次glepaglutide治疗的患者，14%的患者（n=5）实现不再需要PS辅助治疗，而安慰剂治疗患者均不能停用PS。 活性成分：Lazertinib 适应症：非小细胞肺癌（NSCLC） 公司名称：强生（Johnson & Johnson） Lazertinib是一款具脑渗透性的第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）口服药物，其靶向T790M突变和EGFR激活突变，但不靶向野生型EGFR。强生在去年12月宣布向美国FDA递交申请，寻求批准lazertinib联合EGFR/MET双特异性抗体Rybrevant（amivantamab）用于一线治疗EGFR外显子19缺失（ex19del）或L858R替代突变的局部晚期或转移性NSCLC成人患者。 MARIPOSA临床3期试验的分析显示，amivantamab联合lazertinib与活性对照TKI药物相比，在作为一线疗法治疗带有EGFR ex19del或L858R突变的局部晚期或转移性NSCLC患者时，可使患者的疾病进展或死亡风险降低30%（HR=0.70；95% CI：0.58-0.85；p<0.001）。此外，amivantamab和lazertinib组合与活性对照药物相比，在这些患者中的总生存期展现有利趋势（HR=0.80；95% CI：0.61-1.05；p=0.11）。 活性成分：Axatilimab 适应症：移植物抗宿主病（GvHD） 公司名称：Incyte、Syndax Pharmaceuticals Axatilimab是一款集落刺激因子-1受体（CSF-1R）靶向抗体。在一项用以评估axatilimab在接受过两种及以上先前治疗的复发性或难治性慢性GvHD患者的1/2期临床试验，分析显示，在剂量递增试验当中，接受axatilimab治疗总体病患的ORR为67%。在试验的2期部分，每2周给予1 mg/kg axatilimab患者的ORR为82%。实现缓解的患者中有52%的人的糖皮质激素使用剂量减少。Axatilimab实现了广泛的多器官临床益处，包括在经过大量预处理的患者群体中观察到的肺、皮肤、关节和筋膜部位的缓解。此外，axatilimab的耐受性良好，在该难治性人群中具有良好的安全性。 了解更多FDA获批新药 请点击下图访问我们的小程序 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review. Retrieved August 1, 2024 from https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/260/adaptimmune-announces-u-s-fda-acceptance-of-biologics [2] Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. Retrieved August 1, 2024 from https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic [3] Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism. Retrieved August 1, 2024 fromhttps://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-announces-extension-us-food-and-drug-1 [4] Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis. Retrieved June 5, 2024 from https://www.businesswire.com/news/home/20240604334684/en/Gilead%E2%80%99s-Seladelpar-Demonstrated-a-Sustained-and-Consistent-Long-Term-Efficacy-and-Safety-Profile-in-Primary-Biliary-Cholangitis [5] FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse glioma. Retrieved February 20, 2024 from https://www.prnewswire.com/news-releases/fda-and-ema-accept-vorasidenib-regulatory-submissions-for-the-treatment-of-idh-mutant-diffuse-glioma-302064504.html [6] Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review. Retrieved February 21, 2024 from https://www.globenewswire.com/news-release/2024/02/21/2832630/0/en/Linvoseltamab-BLA-for-Treatment-of-Relapsed-Refractory-Multiple-Myeloma-Accepted-for-FDA-Priority-Review.html [7] Zealand Pharma submits New Drug Application to the US FDA for glepaglutide in short bowel syndrome. Retrieved December 22, 2023 from https://www.globenewswire.com/en/news-release/2023/12/22/2800463/0/en/Zealand-Pharma-submits-New-Drug-Application-to-the-US-FDA-for-glepaglutide-in-short-bowel-syndrome.html [8] Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC). Retrieved December 21, 2023 from https://www.jnj.com/johnson-johnson-submits-supplemental-biologics-license-application-and-new-drug-application-to-u-s-fda-seeking-approval-of-rybrevant-amivantamab-vmjw-plus-lazertinib-for-the-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer-nsclc [9] Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease. Retrieved August 1, 2024 from https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-food-and-drug-administration-grants-priority 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新