Product Pipeline
Delova Biotech focuses on the unmet medical needs in the field of pain in both China and U.S. The Company has laid out nearly 10 new non-opioid analgesics, which have sequentially entered the clinical development stage. The Company has also applied for nearly 20 key patents.
Project Mechanism Indication Country Preclinical IND Phase Ⅰ Phase Ⅱ Phase Ⅲ NDA
Project QP001
Mechanism NSAIDS
Indication Postoperative pain
Country
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
-
临床前
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
-
临床前
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
QP001 is the first new long-acting post-operative analgesic drug independently developed by Delova Biotech, which is a new NSAID injection with a COX-2 mechanism. Its 24-hour long-acting strong analgesic ability and low incidence of adverse reactions can fill the gap of long-acting NSAID injection in China, with significant clinical advantages compared with existing treatments.
Domestic Phase I and Phase II clinical studies of QP001 have been completed, and the Phase III clinical trial is ongoing. The Company is expected to submit a domestic New Drug Application (NDA) of QP001 in the third quarter of 2023.
In addition, the Company has completed the pivotal clinical study of QP001 for the U.S. NDA and successfully met the primary study endpoint. A pre-NDA meeting was held with the FDA on August 18, 2022, and several agreements were reached, and an NDA for QP001 is expected to be submitted to the FDA in the coming months.
QP001 is expected to be the first new drug marketed simultaneously in China and the U.S. by Delova, and also the first new analgesic drug in China to "go abroad to the United States".
Project QP002
Mechanism Local paralysis
Indication Postoperative pain
Country
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
-
临床前
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
-
临床前
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
QP002 is the second new long-acting postoperative analgesic drug independently developed by Delova Biotech, based on XisGel® patented extended-release technology platform. It is the first new drug for postoperative analgesia that can be administered by instillation in China, providing long-lasting analgesia for more than 72h with a single dose. Compared with similar drugs globally, QP002 has the advantages of higher drug loading capacity, smaller drug delivery volume, greatly enhanced clinical convenience, and lower cost.
Till now, the Company officially received the domestic drug clinical trial approval notice for QP002 on July 29, 2022.
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
QP001注射液是清普生物系列非阿片类镇痛新药管线的首款产品,中美双报,为国内首款24h长效的NSAIDs注射液,可用于治疗各类急性疼痛,尤其适用于围术期镇痛,相比现有同类药物在镇痛强度、安全性和镇痛维持时间上均有显著优势。QP001项目基于清普自主知识产权的难溶药物增溶技术平台(SimSolTM)开发,核心发明专利通过PCT途径进入中国、美国、欧洲、日本、韩国等多个国家,且已在中国和日本获授权,其余国家陆续进入实质审查阶段。
公司已完成国内1项I期临床、1项II期临床和2项III期临床研究,2项III期临床均达到主要疗效终点和全部次要疗效终点,主要疗效指标优于国内已上市药物。公司已于2023.9.7获得国内新药上市申请(NDA)的正式受理,目前处于实质审查阶段。
公司已完成了美国NDA的关键临床研究,并成功达到主要研究终点,于2022年08月18日同FDA召开pre-NDA会议,达成多项共识,并获得QP001项目的"Application Fee Waivers"(注册费用减免),成为国内极少数获得FDA注册费用减免优惠的生物医药公司之一。2023.7.9 QP001 NDA得到FDA正式受理。
QP001有望成为清普首款中美同步上市的新药,也是国内首款"出海美国"的镇痛新药。
QP002是国内首款3-5天长效,全新给药方式的局麻类镇痛药,用于术后镇痛。QP002基于系列长效缓释注射剂平台的XisGel®凝胶技术开发,相比同类品种,QP002具有可局部定位、载药量更高、给药体积更小、载体局部相容性更优、极大提升临床给药便利性等优势。
公司已完成QP002的I期临床试验,目前正在进行多项II期临床研究,其中首个II期临床已完成全部受试者入组。
QP002和XisGel®凝胶技术的核心发明专利通过PCT途径进入中国、美国、欧洲、日本、韩国、加拿大、澳大利亚、东南亚等多个国家,其中国内已授权3项,其余国家陆续进入专利公开阶段。
Other pipeline products are to be disclosed.