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HaiChuang Pharmaceutical (688302.SH): The clinical trial of HP560 tablets for the treatment of bone marrow fibrosis has obtained a drug clinical trial approval notice.
On July 24th, Gelunhui announced that Haichuang Pharmaceutical (688302.SH) received the Drug Clinical Trial Approval Notice issued and approved by the Drug Evaluation Center of the China National Medical Products Administration, agreeing to conduct clinical trials of HP560 tablets for the treatment of myelofibrosis. As of the date of this announcement, no similar target product has been approved for listing both domestically and overseas.
Hinova Pharmaceuticals Gets US FDA's Nod to Trial HP537 Tablets
Express News | Hinova Pharma Receives U.S. FDA Study May Proceed Notification for Phase I/II Clinical Trial of HP537 for Treatment of Hematological Malignancies
Hai-Chuang Pharmaceutical (688302.SH) received FDA approval for Phase I/II clinical trials of HP537 tablets for the treatment of hematologic malignancies.
Zhitong Finance APP News, Hicreative Pharmaceutical (688302.SH) announced that the company recently received the Study May Proceed Notification issued by the Food and Drug Administration (FDA), approving the company's clinical phase I/II trial application of HP537 tablets for the treatment of hematologic malignancies. Prior to this, the clinical trial application of HP537 tablets in China had been approved by the National Medical Products Administration (NMPA) in February 2024.
Express News | Hinova Pharmaceuticals Receives FDA Fast Track Designation for HP518 for Treatment of Ar+ Triple-Negative Breast Cancer (Tnbc)
Hai-Chuang Pharmaceutical (688302.SH): Its investigational drug HP518 has received Fast Track Designation from the United States Food and Drug Administration for the treatment of androgen receptor (AR)-positive triple-negative breast cancer.
On June 30th, Gelunhui reported that Haichuang Pharmaceutical Co., Ltd. (688302.SH) recently received "Fast Track Designation" ("FTD") from the US Food and Drug Administration ("FDA") for its HP518 tablets for the treatment of androgen receptor (AR) positive triple-negative breast cancer. Currently, there are no similar targeted products approved for marketing at home or abroad. Previously, HP518 tablets have been used in Australia to treat metastatic castration-resistant prostate cancer.
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