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[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppositories in the treatment of cervical high-risk human papillomavirus 16/18 (HR-HPV16/18) infection combined with low-grade squamous intraepithelial lesions (CINI/P16 negative CINII)

（1）探索保妇康栓治疗宫颈 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的最佳给药方案。（2）初步评价保妇康栓治疗 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的有效性和安全性。（3）初步评价保妇康栓治疗宫颈 HR-HPV16/18 感染的有效性和安全性。

[Translation]

(1) To explore the optimal dosing regimen of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (2) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (3) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection.

Start Date12 Mar 2021

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

CTR20210286

/ RecruitingPhase 2

保妇康栓治疗宫颈高级别鳞状上皮内病变（P16阳性的CINII）有效性和安全性的随机、双盲、安慰剂平行对照、多中心II期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial on the efficacy and safety of Baofukang suppositories in the treatment of high-grade cervical squamous intraepithelial lesions (P16-positive CINII)

（1）探索保妇康栓治疗HSIL（P16阳性的CINII）的最佳给药方案。（2）初步评价保妇康栓治疗HSIL（P16阳性的CINII）的有效性和安全性。（3）初步评价保妇康栓治疗宫颈HR-HPV感染的有效性和安全性。

[Translation]

(1) To explore the optimal dosing regimen of Baofukang suppository for the treatment of HSIL (P16-positive CINII). (2) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of HSIL (P16-positive CINII). (3) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of cervical HR-HPV infection.

Start Date09 Mar 2021

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hainan Bikai Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Hainan Bikai Pharmaceutical Co. Ltd.

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7

Literatures (Medical) associated with Hainan Bikai Pharmaceutical Co. Ltd.

18 Oct 2019·Natural Product ResearchQ3 · CHEMISTRY

Three new labdane-type diterpenoids from Callicarpa macrophylla Vahl.

Q3 · CHEMISTRY

Article

Author: Yang, Lan-Ping ; Meng, Yue-Li ; Zhang, Qing-Ling ; Zhang, Yan-Ru ; Zhai, Yang-Yang ; Niu, Chao ; Zhang, Wen-Kui ; Huang, Mei ; Wang, Zhen-Hui ; Li, Qiang ; Xu, Huan-Jun ; Chen, Xing-Ying

Three new labdane-type diterpenoids, callicapene M3-M5 (1-3) were isolated from the Callicarpa macrophylla Vahl. Their structures were identified by spectroscopic method. The isolated compounds were evaluated for inhibitory activity on NO production in LPS-activated RAW 264.7 macrophage cells by using MTT assays. Compounds 1-3 showed potent inhibitory activity, with IC₅₀ value of 48.15, 46.31 and 38.72 μM respectively.

Zhongnan Yaoxue

Tissue distribution and excretion of docetaxel submicron emulsion

Author: Shi, Chaohui ; Tan, Yinfeng ; Liu, Qiang ; Kuang, Shaoyi ; Fu, Naiguang ; Tang, Jing ; Zhang, Li

The tissue distribution and excretion of docetaxel submicron emulsion in rats were investigated.A high-performance liquid chromatog. (HPLC) with UV detection was developed to study the concentration of docetaxel in the biol. samples.Taking paclitaxel as an internal standard, 48 SD rats were randomly divided into 2 groups: test preparation and reference preparation, and each group was i.v. administered 75 mg·m^-2 DTX.The rats were executed at 5, 30, 60 and 300 min, and tissues were taken in the same location to determine the content.The docetaxel submicron emulsion was widely distributed in the tissues of the body.The docetaxel concentration of the test group in the heart and lung was lower than that of the reference group, but higher than the reference group in the spleen.In the kidney, the docetaxel concentration of the test group increased quickly before 30 min and was higher than the reference group, and after that the concentration decreased even lower than the reference injection.The docetaxel concentrations of the 2 groups in other tissues and organs had no significant difference.The excretion of the parent drug in the urine and excrement amounted to 2% and 6% of the dose, resp.Submicron emulsion had no significant effect on docetaxel distribution, and the preparation was delivered effectively.In safety and pharmacodynamic evaluation, more attention should be paid to the alteration of toxicity and therapeutic effect after changing dosage forms.

Hainan Yixueyuan Xuebao

Study on preparation technique of zedoary turmeric oil and borneol soft capsule

Author: Huang, Xian

To probe the optimal technol. of preparation technique of zedoary turmeric oil and borneol soft capsule.Studied the preparation technique systematically by screening, including the shell composition of the soft capsule, the diluent of contents, the proportion of zedoary turmeric oil and borneol and diluent, and the drying of the soft capsule.The optimal preparation technique of zedoary turmeric oil and borneol soft capsule were: heating 400 mL polyethylene glycol to 80°, putting into borneol, after it was dissolved completely adding 4000 mL polyethylene glycol and stirring to dissolution, when the temperature of it dropped to 40-50°, putting into zedoary turmeric oil and stirring to make even, after the temperature dropped to 25-30°, processing by colloid mill, the output being the content of the soft capsule, filling the soft capsule with it and sealing under the constant temperature, and drying the soft capsule for 6 h in the condition of 35° and 30% relative humidity.The technique for preparation of zedoary turmeric oil and borneol soft capsule is stable and feasible.

100 Deals associated with Hainan Bikai Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Hainan Bikai Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 11 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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