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CSPC Pharma Unit, Alphamab Oncology's Breast Cancer Drug Application Granted Priority Review in China

CSPC Pharmaceutical (HKG:1093) said a new drug application for Anbenitamab was accepted by China's National Medical Products Administration, according to a Tuesday Hong Kong bourse filing.The application for Anbenitamab, co-developed by Shanghai JMT-Bio Technology, a unit of the company, and Alphamab Oncology (HKG:9966), has also been included in the priority review and approval procedures.The indication for the application is Anbenitamab in combination with docetaxel (albumin-bound) ± carboplatin as neoadjuvant therapy to treat breast cancer in adults.

HKG:1093HKG:9966

CSPC Pharma Begins Phase Ib/II Trial of Colorectal Cancer Drug Candidate

CSPC Pharmaceutical (HKG:1093) initiated a phase Ib/II clinical trial of the combination therapy of its SYS 6090 Injection at the first research center in China.The drug is being tested for the treatment of colorectal cancer, according to a Monday Hong Kong bourse filing.Pre-clinical study results showed the drug candidate significantly inhibited tumor growth with favorable safety and tolerability.

CSPC Pharma Wins China Trial Approval for RSV Vaccine

CSPC Pharmaceutical (HKG:1093) said China's National Medical Products Administration approved clinical trials for its recombinant respiratory syncytial virus (RSV) vaccine candidate, SYS6057, according to a July 31 Hong Kong bourse filing.The vaccine is intended to prevent lower respiratory tract disease caused by RSV in people aged 60 and older

CSPC Pharmaceutical Starts Phase 2 Trial of Hypertension Drug

CSPC Pharmaceutical (HKG:1093) has initiated the first China study site for a Phase 2 clinical trial of SYH2062 injection for the treatment of adult essential hypertension, according to a Wednesday Hong Kong bourse filing.The multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy and safety of the RNA interference therapy in patients with mild-to-moderate essential hypertension.Patient recruitment and screening are underway, according to the filing.

CSPC-Licensed Oropharyngeal Cancer Drug Cleared for U.S. Registrational Trial

CSPC Pharmaceutical (HKG:1093) said Corbus Pharmaceuticals has received U.S. FDA clearance to begin a registrational trial of CRB-701 (SYS6002), which it is developing under license from CSPC, for second-line treatment of oropharyngeal squamous cell carcinoma.The TEMPO-1 study will evaluate the antibody-drug conjugate against the investigator's choice of capecitabine, cetuximab, or docetaxel, with objective response rate and overall survival as the primary endpoints, according to a Wednesday filing with the Hong Kong bourse.Corbus expects to begin patient enrollment in the third quarter of 2026.

CSPC Pharma's Depression Drug Meets Primary Endpoint in Phase 3 Trial

CSPC Pharmaceutical (HKG:1093) said its Phase 3 clinical trial of Ammoxetine Hydrochloride Enteric-coated Tablets met its primary endpoint in patients with depression, according to a Monday filing with the Hong Kong bourse.The trial showed the drug significantly improved Montgomery-Åsberg Depression Rating Scale (MADRS) scores after eight weeks of treatment compared with placebo and was numerically superior to the active control.HA1406 also demonstrated favorable trends across multiple secondary endpoints and a good safety profile, the company said.

CSPC Pharma's Sirolimus Drug Application Accepted in China

CSPC Pharmaceutical (HKG:1093) said China's National Medical Products Administration accepted the new drug application for its independently developed Sirolimus for Injection, according to a Monday filing with the Hong Kong bourse.The application seeks approval for the treatment of unresectable locally advanced or metastatic malignant perivascular epithelioid cell tumor (PEComa).

CSPC Pharma Starts Phase 2 Trial of HPV Therapeutic Vaccine in China

CSPC Pharmaceutical Group (HKG:1093) initiated a Phase 2 clinical trial in China for its SYS6026 Injection to treat HPV type 16- or 18-related cervical high-grade squamous intraepithelial lesions, according to a Wednesday Hong Kong bourse filing.SYS6026 is an investigational therapeutic mRNA vaccine targeting the E6 and E7 protein antigens of HPV types 16 and 18.The company said the vaccine is designed to stimulate an immune response that eliminates HPV-infected or tumor cells expressing the target antigens.

CSPC Pharma's Application for Breast Cancer Drug Candidate Accepted in China

CSPC Pharmaceutical's (HKG:1093) new drug application for Trastuzumab Envedotin Injection was accepted by China's National Medical Products Administration.The acceptance is for the indication of the treatment of unresectable or metastatic HER2-positive breast cancer in adult patients, according to a Friday Hong Kong bourse filing.

CSPC Pharma Begins Two Drug Trials in China

CSPC Pharmaceutical (HKG:1093) initiated two clinical trials at their first centers in China, according to two Hong Kong bourse filings on Thursday.The pharma company began a phase II study of Sirolimus for Injection to treat patients with progressive/symptomatic epithelioid haemangioendothelioma.A phase III clinical trial of SYS6043 versus chemotherapy for the treatment of participants with platinum-resistant advanced ovarian cancer, primary peritoneal cancer, and fallopian tube cancer was also initiated.

CSPC Pharma's Breast Cancer Drug Combination Granted China Breakthrough Designation

CSPC Pharmaceutical's (HKG:1093) albumin-bound docetaxel and anbenitamab combination received breakthrough therapy designation in China for the first-line treatment of unresectable or metastatic HER2-positive breast cancer, according to a Tuesday filing with the Hong Kong bourse.The designation follows positive phase 3 results announced in June, when the combination significantly improved progression-free survival compared with the current standard-of-care regimen.The therapy also demonstrated a favorable safety profile, the company said.CSPC plans to submit a new drug application for the indication in the near term.

CSPC Pharma Begins Tumor Drug Trial in China

CSPC Pharmaceutical (HKG:1093) began the phase 1 study of SYH2095 tablets, co-developed with Hangzhou Innogate Pharma, in China.The drug is being tested to treat advanced malignant tumors as a monotherapy or in combination regimes.

CSPC Pharma's Tumor Drug Gets Breakthrough Therapy Designation in China

CSPC Pharmaceutical's (HKG:1093) SYS6043 was granted breakthrough therapy designation from China's National Medical Products Administration.The proposed indication is for the treatment of platinum-resistant ovarian cancer, primary peritoneal carcinoma, and fallopian tube cancer as a monotherapy, according to a Thursday filing.

CSPC Pharma Gets Marketing Nod for Anemia Drug in China

CSPC Pharmaceutical (HKG:1093) obtained marketing approval for its iron sucrose injection from China's National Medical Products Administration.The product is indicated for patients with iron deficiency anemia who don't respond satisfactorily to oral iron preparations, according to a Thursday filing.

CSPC Pharma Gets China Nod for Trial of Herpes Zoster Vaccine

CSPC Pharmaceutical (HKG:1093) obtained approval for a clinical trial of recombinant herpes zoster vaccine from China's National Medical Products Administration.The indication for the approval is for the prevention of herpes zoster and its complications in adults aged 50 years and above, according to a Thursday filing.

CSPC Pharma, AstraZeneca Enter Development Deal for Potential Renal Disease Drug Candidates

CSPC Pharmaceutical (HKG:1093) agreed to a strategic research deal for two of its drug platforms for renal disease treatment with pharmaceutical giant AstraZeneca, according to a Thursday filing.The collaboration, option and license agreement will cover the Hong Kong-listed drugmaker's siRNA drug discovery and extrahepatic targeted delivery platforms for the development of novel small nucleic acid drug candidates.CSPC will receive $30 million upfront, up to $540 million in development milestone payments, up to $1.2 billion in sales milestone payments and single-digit royalties based on annual sales.The two companies plan to use the platforms to develop preclinical candidates. Each resulting program gives AstraZeneca the option to obtain exclusive rights globally or outside China, while CSPC will retain the development, manufacturing and commercialization rights for one of the candidates in China.

CSPC Pharmaceutical Begins Lung Cancer Trial in China

CSPC Pharmaceutical (HKG:1093) said it began a phase 3 trial of SYS 6010 in China, according to a Hong Kong bourse filing Tuesday.The firm will study a combination of the drug with enlonstobart to study its effectiveness in patients with completely resected stage II-III B non-small cell lung cancer who have no actionable genomic alterations and have not achieved major pathological response.

CSPC Pharma Begins Phase III Trial of SYS6010 Combo for Lung Cancer Treatment

CSPC Pharmaceutical (HKG:1093) began a phase III study of SYS6010 in combination with enlonstobart in China.The drug is being tested for the treatment of non-small cell lung cancer, according to a Friday Hong Kong bourse filing.The first subject will be enrolled in the trial in July.

CSPC Pharma Unit Files New Application for Hong Kong Share Listing

CSPC Pharmaceutical (HKG:1093) unit CSPC Innovation submitted another listing application to the Hong Kong Stock Exchange for the proposed listing of its Hong Kong-listed shares after its previous application lapsed, according to a Thursday bourse filing.It is expected that CSPC Innovation will remain an indirect subsidiary of the pharma company after the listing.Details of the listing, such as the timetable, size, and structure of the offering, are yet to be finalized.The listing is subject to the relevant regulatory approvals.

CSPC Pharma's Tumor Drug Gets Trial Nod from US FDA

CSPC Pharmaceutical Group (HKG:1093) obtained clinical trial approval for Octreotide Long-acting Injection from the U.S. Food and Drug Administration (FDA), according to a Thursday Hong Kong bourse filing.The drug is used for the first-line treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors.

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