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SHE:000963

16 stories mentioning SHE:000963Updated 3d ago

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Chinese Drug Regulator Accepts Huadong Medicine's Registration Application for Primelase Semiconductor Laser Therapy System

China's National Medical Products Administration accepted Huadong Medicine's (SHE:000963) application for the registration of its Primelase Semiconductor Laser Therapy System, according to a Shenzhen bourse filing on Tuesday.Primelase, which is developed by subsidiary High Technology Products, is a semiconductor laser multi-parameter adjustable therapeutic device,The drugmaker's shares slipped 1% at the close.

Huadong Medicine's H1 Profit Rises 3%, Revenue Climbs 2%

Huadong Medicine's (SHE:000963) net profit attributable to shareholders in the first half rose 2.5% to 1.86 billion yuan from 1.81 billion yuan a year earlier, according to a Shenzhen bourse filing on Thursday.Earnings per share increased 2.6% year on year to 1.06 yuan from 1.03 yuan.Operating revenue climbed 1.8% to 22.1 billion yuan from 21.7 billion yuan in the previous year.The Chinese drugmaker proposed to distribute a cash dividend of 3.50 yuan per 10 shares to shareholders.The company's shares rose 1% at the close.

Huadong Medicine's Lymphoma Drug Gets US FDA's Fast Track Designation

Huadong Medicine's (SHE:000963) HDM2005 for injection obtained a fast track designation from the U.S. Food and Drug Administration, according to a Shenzhen bourse filing on Thursday.The drug is being developed as a treatment for patients with relapsed or refractory mantle cell lymphoma, who had at least two lines of systemic therapy, including a BTK inhibitor.The Chinese drugmaker's shares rose 1% at the close.

Huadong Medicine Secures China Regulatory Nod For Undereye Filler

Huadong Medicine's (SHE:000963) UK-based aesthetic subsidiary Sinclair Pharmaceuticals has received approval from China's National Medical Products Administration for its undereye filler, MaiLiPrecise.MaiLiPrecise is the first injectable product in China for treating infraorbital, or undereye, retraction, according to a Shenzhen bourse filing on Wednesday.The product is part of the MaiLi line of dermal fillers produced by Sinclair. It originated from Kylane Laboratoires, a Swiss professional medical aesthetics R&D company in which Sinclair holds a stake, Huadong said.

Huadong Medicine's UK Arm Receives EU Certification for Intradermal Injection

Huadong Medicine's (SHE:000963) UK subsidiary, Sinclair Pharma, received European Union CE certification for its carboxymethyl chitosan injection solution, according to a Monday filing with the Shenzhen bourse.The product can be marketed in the EU, Huadong said.The product, branded Kytogen Defend, is indicated for intradermal injection, superficial filling, skin texture improvement and skin hydration, the company said. KIO015 is the product's development code.The product is the first of its kind not derived from animal products, Huadong said.Shares of the pharmaceutical company rose 2% in recent trade.

Huadong Medicine Wins Pre-Bids for Three Drugs Under China Procurement System

Huadong Medicine (SHE:000963) won pre-bids for three of its products under China's drug procurement program, according to a Monday disclosure to the Shanghai bourse.The pre-selected drugs include the cyclosporine soft capsules and tacrolimus capsules for immunology, as well as mesalazine enteric-coated tablets for inflammatory bowel diseases.Total sales of its winning products reached 2.08 billion yuan in 2025.Shares fell 2% during the midday break on Monday.

Huadong Medicine's Attributable Profit Jumps 9.6% in H1

Huadong Medicine's (SHE:000963) attributable profit rose 9.6% to 1.00 billion yuan in the first half from 914.7 million yuan in the year-ago period, according to a Thursday filing with the Shenzhen bourse.Earnings per share at the drug maker increased 9.6% to 0.5715 yuan from 0.5213 yuan in the previous year.Operating revenue grew 4.2% year over year to 11.2 billion yuan from 10.7 billion yuan.

Huadong Medicine Gets Clinical Trial Approval for Cancer Drug; Shares Down 3%

Huadong Medicine (SHE:000963) obtained the approval of China's drug regulator to conduct clinical trials for HDM2017 injection combination therapy in advanced colorectal cancer.Preclinical data show the drug has efficacy across digestive tract malignancies with favorable tolerability in animal studies, according to a Friday filing on the Shenzhen bourse.Shares of the pharmaceutical company fell 3% in recent trade.

Huadong Medicine's Unit Gets Registration Certificate for V30 Skin Treatment System

Huadong Medicine's (SHE:000963) unit, Viora, received a medical device registration certificate from China's National Medical Products Administration for its V30 Skin Treatment System, according to a Shenzhen bourse filing on Thursday.The skin treatment platform can be used with the V-IPL IPL handpiece, V-ST RF handpiece or the V-Nd:YAG laser handpiece to reduce wrinkles, treat vascular or pigmented lesions and acne, and remove hair.The pharmaceutical company's shares fell 1% during the afternoon trade.

Huadong Medicine Gets China Nod for Lymphoma Combo Trial

Huadong Medicine (SHE:000963) subsidiary Zhongmei Huadong obtained the approval of China's drug regulator to conduct clinical trials of HDM2005 in combination with PD-1 and AD chemotherapy for classical Hodgkin's lymphoma.The drug is already in trials for multiple hematologic and solid tumor indications in China and the U.S., according to a Thursday filing with the Shenzhen bourse.Shares of the drugmaker declined 1% in recent trade.

Chinese Drug Regulator Accepts Huadong Medicine's Application for Facial Filler's New Indication

China's National Medical Products Administration accepted Huadong Medicine's (SHE:000963) application to add a new indication for a facial filler, according to a Shenzhen bourse filing on Wednesday.The Chinese drugmaker applied for the Ellansé S Injectable Polycaprolactone Microsphere Facial Filler to be used as an implant into the forehead to improve moderate to severe forehead contour defects.The company's shares jumped 5% at the close.

Huadong Medicine's Unit Gets Nod to Trial HDM2017 for Injection

Huadong Medicine's (SHE:000963) unit, Hangzhou Sino-American Huadong Pharmaceutical, received approval from China's National Medical Products Administration for the clinical trials of HDM2017 for injection, according to a Shenzhen bourse filing on Thursday.The drug is used in combination with Fruquintinib for the treatment of advanced colorectal cancer.

Huadong Medicine's Attributable Profit Jumps 9.6% in Q1; Shares Rise 3%

Huadong Medicine's (SHE:000963) attributable profit rose 9.6% to 1.00 billion yuan in the first quarter from 914.7 million yuan in the year-ago period, according to a Friday filing with the Shenzhen bourse.Earnings per share at the drug maker increased to 0.5715 yuan from 0.5213 yuan in the prior-year period.Operating income grew 4.2% year over year to 11.2 billion yuan from 10.7 billion yuan.Shares increased 3% during afternoon trading on Friday.

Huadong Medicine's Attributable Profit Slips 2.8% in 2025

Huadong Medicine's (SHE:000963) attributable profit fell 2.8% year over year to 3.41 billion yuan in 2025, according to a Friday filing with the Shanghai bourse.Operating revenue jumped 4.1% year over year to 43.6 billion yuan.Shares increased 3% during afternoon trading on Friday.

Huadong Medicine Registers New Aesthetics Product Variant in China; Shares Jump 4%

Huadong Medicine (SHE:000963) has obtained a medical device registration certificate from China's National Medical Products Administration for a new variant of its Ellansé aesthetics product, according to a Shenzhen Stock Exchange filing on Friday.The newly approved Ellansé M-type is a Class III medical device for injection containing polycaprolactone microspheres for facial filling. It has been approved for market launch, said Huadong.The M-type variant is designed for the temporal region. Huadong has already been marketing its Ellansé S-type product in China since August 2021.Shares of the company rose 4% in recent trade.

Huadong Medicine's Weight-Loss Drug Marketing Application Accepted in China

Huadong Medicine (SHE:000963) said China's drug administrator accepted its marketing application for semaglutide injection.The drug is used for long-term weight management in obese or overweight adults, according to a Wednesday filing with the Shenzhen bourse.Shares of the drugmaker closed 2% higher Wednesday.

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