2018年3月23日，日本厚生劳动省（MHLW）已批准Hernicore(Condoliase，ヘルニコア椎間板注用，开发代码：SI-6603）1.25单位，用于治疗腰椎间盘突出症。
Hernicore®1.25单位椎间盘内注射（“药剂”）是一种新的治疗腰椎间盘突出症的选择，其活性药物成分为condoliase。这是日本第一种椎间盘内给药的治疗药物。不需要全身麻醉，对患者的侵入性比手术治疗小。
在Seikagaku在日本进行的III期临床试验中，与安慰剂组相比，主要终点（给药后13周最严重腿部疼痛的变化）有了显著改善。
由于单次给药有望改善腰椎间盘突出症的症状，Seikagaku认为这种新的治疗方案能够提高患者的生活质量。
<产品概述>
商品名； HERNICORE® 1.25 Units for Intradiscal Injection
通用名： condoliase
适应症：腰椎间盘突出症由后纵韧带脱垂引起，保守治疗无法获得充分改善
用法用量：对于成年人来说，1.25单位的condoliase是通过在椎间盘中单次注射给药的，椎间盘是症状的来源。
作用机制：预计condoliase可以降解硫酸软骨素、软骨素和透明质酸，并改善临床
椎间盘突出症的表现是由于椎间盘内的糖胺聚糖溶解而降低椎间盘内压，降低髓核的持水能力。
*糖胺聚糖（GAG）：复合碳水化合物的主要成分。软骨素、透明质酸等。
关于腰椎间盘突出症和治疗
腰椎间盘突出症是指每个椎间盘核心或椎间盘外层纤维环的髓核部分突出。由此产生的脊髓神经根压力会导致疼痛和麻木。
目前的治疗方法通常分为暂时缓解疼痛的保守治疗（休息和药物方法，如非甾体抗炎药）和手术治疗。
由于该药物能特异性降解髓核中的GAG，从而降低神经根的压力，因此被定位为治疗腰椎间盘突出症的创新疗法。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3999447D1020_1_01/
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HERNICORE® 1.25Units for Intradiscal Injection in Japan, Indicated
Seikagaku Corporation(Tokyo, Japan; 'Seikagaku')and Kaken Pharmaceutical Co. Ltd.(Tokyo, Japan; 'Kaken') announced today that HERNICORE® 1.25 units for intradiscal injection(generic name: condoliase)has been listed in the National Health Insurance drug price list. The planned launch date is August 2018.
HERNICORE® 1.25 units for intradiscal injection('the Agent')is a new treatment option for lumbar disc herniation whose active pharmaceutical ingredient is condoliase.This is the first therapeutic Agent in Japan with intradiscal administration. It does not require a general anesthesia and is less invasive to the patient than surgical treatment. Seikagaku obtained New Drug Application('NDA')approval for the Agent in Japan on March 23, 2018, and Kaken will distribute it in Japan. As improvement effects to the symptoms of lumbar disc herniation by prolapse of the posterior longitudinal ligament* are expected by a single administration of the Agent, Seikagaku and Kaken believe that this new treatment option is able to contribute to quality of life of patients.
The Agent is a pharmaceutical with a novel mechanism of action, and from the standpoint of safety assurance, the special Warnings and Precautions for Use in the package insert reads, 'This Agent should be administered under the supervision of a physician with sufficient knowledge and experience in the diagnosis and treatment of lumbar disc herniation. It should be administered by a physician with proficiency in performing lumbar puncture.'
Accordingly, at this time specific physician requirements and facilities requirements are being considered. Kaken will commence sales of the Agent after these requirements have been determined and strive for a phased rollout while promoting appropriate use.
*Herniation by prolapse of the posterior longitudinal ligament:atype of herniation and its structure is that it is covered by the posterior longitudinal ligament, although the hernia extends beyond the outermost layer of the annulus fibrosus
Product name: HERNICORE® 1.25 Units for Intradiscal Injection
Generic name: condoliase
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