10月30日 - 美国食品药品监督管理局周五批准了Inovio制药公司治疗一种罕见呼吸系统疾病的药物，标志着该公司首个获批产品问世。Inovio股价在盘后交易中上涨286%。
Oct 30 - The US Food and Drug Administration on Friday approved Inovio Pharmaceuticals' treatment for a rare respiratory condition, marking the company's first approved product. Shares of Inovio were up 286% in extending trading.
Inovio的疗法INO-3107，商品名为Voceryq，为复发性呼吸道乳头状瘤病患者提供了新的治疗选择，该病会导致气道内长出赘生物，往往需要反复手术。
Inovio's therapy INO-3107, branded as Voceryq, gives a new treatment option for patients with recurrent respiratory papillomatosis, which causes growths in the airways and often requires repeated surgeries.
复发性呼吸道乳头状瘤病的特征是喉部和气道内反复出现疣状赘生物。
Recurrent respiratory papillomatosis is characterized by recurrent wart-like growths in the throat and airways.
该病通常由6型和11型人乳头瘤病毒（HPV）引起，可影响患者说话和呼吸能力。虽然这些赘生物非癌性，但治疗后常复发。
The condition is usually caused by HPV types 6 and 11 and can affect a person's ability to speak and breathe. Although the growths are not cancerous, they often return after treatment.
医生目前通过手术切除赘生物进行治疗，但因病情常复发，许多患者每年需要接受多次手术。
Doctors currently treat it by surgically removing the growths, but many patients require multiple procedures each year because the condition often recurs.
FDA表示，Inovio的Voceryq最常见的不良反应为注射部位反应、头痛、疲劳、高血压、恶心和头晕。
The most commonly reported adverse reactions to Inovio's Voceryq were injection site reactions, headache, fatigue, hypertension, nausea, and dizziness, the FDA said.
Inovio的申请得到一项早期至中期临床研究的支持，该研究针对过去一年至少接受过两次或以上手术的成年患者。
Inovio's application was supported by an early- to mid-stage study in adults who had undergone at least two or more surgeries in the previous year.
去年，Precigen公司的Papzimeos成为首个获美国批准用于治疗成人复发性呼吸道乳头状瘤病的药物。
Last year, Precigen's Papzimeos for adults with recurrent respiratory papillomatosis became the first medicine to get US approval for the disease.
Inovio首席执行官Jacqueline Shea在FDA做出决定前告诉路透社，与Precigen的Papzimeos利用改良病毒触发免疫反应不同，Voceryq是一种基于DNA的免疫疗法。她表示，这两种疗法均旨在产生针对6型和11型HPV的免疫反应，但机制不同。
Inovio CEO Jacqueline Shea told Reuters ahead of the FDA decision that, unlike Precigen's Papzimeos, which uses a modified virus to trigger an immune response, Voceryq is a DNA-based immunotherapy. She said both therapies are designed to generate immune responses against HPV types 6 and 11, but do so through different mechanisms.
Shea称，医生主要寻找能减少手术需求的疗法，并指出每次手术都有导致声带永久损伤的风险。
Shea said physicians are primarily looking for therapies that reduce the need for surgery, noting that every operation carries a risk of permanent vocal cord damage.
Inovio计划自行在美国商业化该疗法，并正与Syneos Health合作支持上市。
Inovio plans to commercialize the therapy on its own in the United States and is working with Syneos Health to support the launch.