Approved for the first time in the US! Fuhong Hanlin Biopharmaceutical's overseas expansion to accelerate PD-1 may become the key to overseas revenue generation
① Recently, the trutuzumab biosimilar drug (Han Quyou) independently developed by Fuhong Hanlin passed FDA approval for commercialization in the US, marking a zero breakthrough in the company's entry into the US market. ② Up to now, the share of overseas sales revenue in Fuhong Hanlin's revenue is still relatively low.
Zhu Jun, CEO of Fuhong Hanlin: Biosimilars contribute to stable cash flow, and rely on innovative drugs to rise above the ceiling
“What biosimilar drugs provide me is a stable cash flow. Each product can provide 1 billion dollars in sales every year. After we have this portion of money, we turn around to make innovative drugs with slightly higher risks, such as developing indications for Hans-like bowel cancer. Other people are afraid to do it; I dare to do it.” Zhu Jun said.
Agency: The synthetic biology sector showed a high increase in Q1 performance, and policy expectations accelerated valuation repair
Currently, the core competitiveness of biological manufacturing companies lies in product development and implementation capabilities. They are optimistic about targets with successful cases, leading positions, high-quality product reserves, and a boom in downstream demand.
Changes in Hong Kong stocks | Fu Hong Hanlin (02696) rose more than 5%, HLX22's international multi-center phase III clinical trial approved in the US
Fu Hong Hanlin (02696) rose more than 5%. As of press release, it had risen 5.42% to HK$17.52, with a turnover of HK$3,019,300.
Henlius Biotech Gets US FDA Clearance for Phase 3 Trial of Gastric Cancer Combination Therapy
Shanghai Henlius Biotech's (HKG:2696) application for the phase 3 clinical trial of HLX22 in combination with Trastuzumab and chemotherapy has been approved by the United States Food and Drug Administ
Fosun Pharmaceutical (600196.SH): The holding subsidiary was approved for clinical trials of drugs by the US FDA
Gelonghui, May 6, 丨 Fosun Pharmaceutical (600196.SH) announced that its holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and its holding subsidiary (hereinafter collectively referred to as “Fuhong Hanlin”) recently received a letter from the US FDA (i.e. the US Food and Drug Administration) agreeing to conduct clinical trials with HLX22 (i.e. anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection) combined with trastuzumab and chemotherapy on the first-line treatment of advanced HER2 positive gastric cancer (hereinafter referred to as “this treatment plan”). Fu Hong Hanlin plans to launch this treatment in the US after conditions are met
Fu Hong Han Lin (02696.HK): The application for a phase 3 clinical trial of HLX22 combined with trastuzumab and first-line chemotherapy to treat advanced HER2-positive gastric cancer was approved by the US FDA
Gelonghui, May 6, 丨 Fu Hong Han Lin (02696.HK) announced that recently, HLX22 (anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection) (“HLX22”) combined with trastuzumab and chemotherapy for first-line treatment of advanced HER2-positive gastric cancer was approved by the US Food and Drug Administration (FDA). According to reports, HLx22 is a novel monoclonal antibody targeting HER2, which was introduced by the company with permission from ABClon, Inc., and subsequently independently developed. Potential indications include solid tumors such as stomach cancer and breast cancer. It is already in China
Henlius Trastuzumab Erhält FDA-Zulassung in Den Vereinigten Staaten
SCHANGHAI, 6. Mai 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) gab bekannt, dass der Geschäftspartner des Unternehmens, Accord BioPharma Inc. (die US-Spezialitätenabteilung von Intas Pharma
Henlius Trastuzumab Reçoit L'approbation De La FDA Aux États-Unis
SHANGHAI, 6 mai 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) a annoncé que le partenaire commercial de la société, Accord BioPharma Inc. (la division spécialisée américaine d'Intas Phar
HENLIUS BIOTECH(2696.HK):STRONG PRODUCT SALES IN 1Q
Strong sales maintained in 1Q24. Henlius Biotech (Henlius) recorded total revenu
Henlius Biotech Logs 1.35 Billion Yuan Revenue in Q1
Shanghai Henlius Biotech (HKG:2696) recorded an operating income of about 1.35 billion yuan for the first quarter of the year, according to the company's filing on the Hong Kong Stock Exchange. Two of
Henlius Trastuzumab Receives FDA Approval in the United States
Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas...
Fuhong Hanlin (02696) achieved revenue of about 1,349 billion yuan in the first quarter
Zhitong Finance App News, Fu Hong Han Lin (02696) announced that in the first quarter of 2024, the Group will seize its existing first-mover advantage, comprehensively promote the product commercialization process, and continue to build innovative business models and optimize resource allocation. During the reporting period, the Group achieved revenue of approximately RMB 1,349 billion. The results of the two core products sold and promoted in China (excluding Hong Kong, Macao and Taiwan regions, same below) led by the Group's self-built commercial team during the reporting period are as follows: Han Quyou (trastuzumab for injection, European trade name: Zercepac, US product name: HERCESSITM,
Shanghai Henlius Biotech's Cancer Drug Gets the Nod From US FDA
The US Food and Drug Administration (FDA) approved Shanghai Henlius Biotech's (HKG:2696) drug HLX02 (trastuzumab for injection) for the treatment of multiple cancers, according to a Friday Hong Kong b
Express News | Fuhong Hanlin HLX02 was approved by the FDA.
Shanghai Henlius Biotech Doses 1st Patient in Fibrosis Drug Clinical Study in China
Shanghai Henlius Biotech (HKG:2696) has dosed the first subject in a phase I clinical study of HLX6018 in healthy subjects in mainland China, a Tuesday filing on the Hong Kong bourse stated. HLX6018 i
Fu Hong Han Lin (02696.HK): The first phase clinical study of HLX6018 in healthy subjects completed the first patient administration in China
Fu Hong Han Lin (02696.HK) announced that recently, the first phase clinical study of HLX6018 (recombinant anti-GARP/TGF-beta1 humanized monoclonal antibody injection) (HLX6018) in healthy subjects completed administration of the first case in China (excluding Hong Kong, Macao and Taiwan regions, same below).
Featured announcements | Xiaopeng and Volkswagen reached a strategic technical cooperation; Sands China's total net revenue increased 42% year over year
Anta Sports: The retail value of Anta brand products achieved a positive year-on-year increase in the number of units in the first quarter; China Building Materials expects a 147% year-on-year increase in net loss for the first quarter.
Henlius Biotech Gets Clearance for China Clinical Trial of Carcinoma Drug
Shanghai Henlius Biotech's (HKG:2696) clinical trial application for HLX53 has been approved by the National Medical Products Administration of China, a Wednesday filing on the Hong Kong bourse said.
Fu Hong Han Lin (02696.HK): A clinical trial application for HLX53 combined with Hans-type and Hanbeitai for first-line treatment of locally advanced or metastatic hepatocellular carcinoma was approved by the State Drug Administration
Gelonghui, April 17, 丨 Fu Hong Han Lin (02696.HK) issued an announcement. Recently, the clinical trial application for HLX53 (anti-Tigit FC fusion protein) (“HLX53”) combined with Hans form (sululimab injection) (“Hans form”) and Hanbetai (bevacizumab injection) (“Hanbetai”) for first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC) was approved by the National Drug Administration (“NMPA”). The company plans to be in China after the conditions are met (excluding Hong Kong, Macao and Taiwan regions,
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