Keji Pharmaceutical-B (02171.HK): Submission of a rectification report on FDA findings
Gelonghui, April 29 | Keji Pharmaceutical-B (02171.HK) issued an announcement. The rectification report on the Corrective and Preventive Measures (CAPAs) plan has been submitted to the US Food and Drug Administration (FDA). This submission relates to findings in Form 483 issued by the FDA after an inspection of the clinical production site in Tulham, North Carolina in December 2023. The relevant work is progressing smoothly according to the schedule previously submitted. The company promises to work closely with the FDA to prioritize quality and ensure the production of clinical trial products.
Hong Kong stocks closed (04.25) | Hang Seng Index closed up 0.48%, domestic housing stocks showed strong performance and fell more than 12% after New Oriental-S (09901) results
The Zhitong Finance App learned that the three major indices of Hong Kong stocks had mixed ups and downs. The Hang Seng Index rebounded for four consecutive trading days. After opening slightly lower in early trading, it quickly rose and turned red. The intraday high was 17,434 points to a new high during the new year, then the increase narrowed, showing a volatile adjustment trend. At the close, the Hang Seng Index rose 0.48% or 83.27 points to 17,284.54 points, with a full-day turnover of HK$119.12 billion; the Hang Seng State-owned Enterprises Index rose 0.33% to 6120.37 points; and the Hang Seng Technology Index fell 0.54% to 3554.3 points. CCB International previously indicated that as the Hang Seng Index stabilized its previous low in late January (20
Changes in Hong Kong stocks | Innovative drug concept stocks rose higher, Keji Pharmaceutical-B (02171) rose more than 11%, and innovative drugs ushered in a full-process support mechanism
Innovative drug concept stocks continued to rise. As of press release, Keji Pharmaceutical-B (02171) rose 10.3% to HK$5.57; Laikai Pharmaceutical-B (02105) rose 9.15% to HK$6.44; and Rongchang Biotech (09995) rose 6.29% to HK$31.25.
科濟藥業-B:二零二三年年度報告
The CAR-T market is approaching 100 billion dollars: domestic companies ensure “survival”, and multinational companies earn dollars
On March 1 of this year, Keji Pharmaceutical-B (02171)'s CAR-T therapy Zewokie Orense injection (SAKIZE) was officially approved for sale, and the number of CAR-T treatments marketed worldwide has also reached 11. Although some of these products compete with each other in terms of treatment of indications, the rapid growth in sales of leading products is still driving the rapid expansion of the global market. The Zhitong Finance App learned that the global CAR-T cell therapy market is expected to reach US$88.52 billion in 2032. The 100 billion dollar market is in sight, and it continues to boost the market's investment confidence. However, not every product
CARsgen Therapeutics Holdings Limited's (HKG:2171) Last Week's 20% Decline Must Have Disappointed Individual Investors Who Have a Significant Stake
Key Insights The considerable ownership by individual investors in CARsgen Therapeutics Holdings indicates that they collectively have a greater say in management and business strategy The top 9 sha
Changes in Hong Kong stocks | Keji Pharmaceutical-B (02171) fell sharply by more than 16%. The company's losses of 748 million yuan in 23 narrowed 16.19% year-on-year
Keji Pharmaceutical-B (02171) fell sharply by more than 16%. As of press release, it fell 16.78% to HK$4.77, with a turnover of HK$4.3 million.
Carsgen Therapeutics To Give Cancer Drug Oral Presentation at ASCO 2024
Carsgen Therapeutics Holdings (HKG:2171) said it will give an oral presentation of satricabtagene autoleucel on June 3 at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024, accordin
Keji Pharmaceutical-B (02171): CT041 abstracts were accepted for oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting
Keji Pharmaceutical-B (02171) issued an announcement. The company's board of directors announced that CT041 (a type of target Claud...
Keji Pharmaceutical-B (02171.HK) made an oral report on the CT041 test data update at the 2024 ASCO Annual Meeting
Gelonghui, April 11 | Keji Pharmaceutical-B (02171.HK) announced that the abstract of CT041 (a candidate product targeting Claudin18.2 autologous CAR-T cells) has been received as an oral report at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. CT041 is a potentially world-first autologous CAR-T cell candidate targeting Claudin18.2 protein. It is used to treat Claudin18.2 positive solid tumors, mainly gastric cancer/esophagastric junction adenocarcinoma and pancreatic cancer. Ongoing trials are included
CARsgen Announced 2023 Annual Results
SHANGHAI, March 27, 2024 /PRNewswire/ -- March 27, 2024, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematol
Keji Pharmaceutical Announces 2023 Annual Results
SHANGHAI, March 27, 2024 /PRNewswire/ -- Keji Pharmaceutical (stock code: 2171.HK), an innovative CAR-T cell therapy company focused on treating hematologic malignancies and solid tumors, announced its 2023 results. Performance highlights at a glance, Saikaize (Zewokie Orense injection, CT053) new drug marketing application approved by the State Drug Administration CT041 received IND approval from the State Drug Administration for adjuvant treatment of pancreatic cancer with positive Claudin18.2 expression CT011 obtained from the State Drug Administration
Keji Pharmaceutical-B (02171) announced annual results. Losses attributable to shareholders of 748 million yuan narrowed 16.19% year-on-year
According to the Zhitong Finance App, Keji Pharmaceutical-B (02171) announced the results for the year ended December 31, 2023. The group achieved R&D expenditure of 662 million yuan (RMB, same below) during the period, a year-on-year decrease of 2.74%; losses attributable to shareholders amounted to 748 million yuan, a year-on-year decrease of 16.19%; and a basic loss of 1.34 yuan per share. According to the announcement, the main reason for the narrowing was the reduction in share-based remuneration, which totaled 14 million yuan for the year ended December 31, 2023, a decrease of 30 million yuan compared to 44 million yuan for the year ended December 31, 2022; R&D
CARSGEN-B: ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2023
Keji Pharmaceutical-B (02171.HK) plans to hold a board meeting on March 26 to approve the annual results
Gelonghui March 12 | Keji Pharmaceutical-B (02171.HK) issued an announcement. The board of directors announced that a board meeting will be held on March 26, 2024 (Tuesday) to consider and approve the Group's annual results for the year ended 31 December 2023, and to deal with other matters.
CARSGEN-B: DATE OF BOARD MEETING
Changes in Hong Kong stocks | Keji Pharmaceutical-B (02171) fell more than 8% in the afternoon, and the initial price of CAR-T therapy was approved for listing in China. The initial price was 1.15 million yuan
Keji Pharmaceutical-B (02171) fell more than 8% in the afternoon. As of press release, it was down 7.66% to HK$5.91, with a turnover of HK$7.542,900.
Keji Pharmaceutical's BCMA CAR-T product Saikaize (Zewokie Orense injection) was approved for marketing in China, benefiting adult patients with recurrent or refractory multiple myeloma
SHANGHAI, March 1, 2024/PRNewswire/ -- Keji Pharmaceutical (stock code: 2171.HK), an innovative CAR-T cell therapy company focusing on the treatment of hematologic malignancies and solid tumors, announced that the National Drug Administration (“NMPA”) has officially approved the new drug marketing application (“NDA”) for treating patients with recurrent or refractory multiple myeloma who have gone through at least 3 stages of treatment for adults CT053 progression after treatment (at least used
Keji Pharmaceutical-B (02171.HK): China Drug Administration approves Saikaize's new drug marketing application
Gelonghui, March 1 | Keji Pharmaceutical-B (02171.HK) announced that the National Drug Administration (“NMPA”) has officially approved the new drug marketing application (“NDA”) of Saekaize (Zevokiolensis injection, product number: CT053, an autologous CAR-T candidate for BCMA) to treat adult patients with recurrent or refractory multiple myeloma, progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulator). Cykaize is an autologous BCMA-targeted CAR-T cell product. It is transferred through lentivirus
Changes in Hong Kong stocks | Keji Pharmaceutical-B (02171) rose more than 10%, the world's first TIL therapy was approved. Listed institutions recommend focusing on the cell therapy circuit
Keji Pharmaceutical-B (02171) rose more than 10%. As of press release, it rose 10.48% to HK$6.22, with a turnover of HK$4.912,300.
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