Core Viewpoint - The approval of two supplemental new drug applications for Selinexor (希维奥) by the Hong Kong Department of Health marks a significant milestone for Dechra Pharmaceuticals-B (德琪医药-B), enhancing its market presence and competitiveness in the biopharmaceutical sector [1]. Company Summary - Dechra Pharmaceuticals-B's stock rose nearly 6%, with a current price of 4.34 HKD and a trading volume of 9.4944 million HKD [1]. - The approved indications for Selinexor include treatment for multiple myeloma in combination with Bortezomib and Dexamethasone for adult patients who have received at least one prior therapy, and for relapsed or refractory diffuse large B-cell lymphoma as a monotherapy for adults who have undergone at least two lines of systemic therapy and are not candidates for hematopoietic stem cell transplantation [1]. Industry Summary - The approval signifies Dechra Pharmaceuticals-B's ongoing enhancement in research and market promotion capabilities within the biopharmaceutical field [1]. - The introduction of Selinexor is expected to address the treatment needs for relevant diseases in the Hong Kong market, thereby improving the company's competitiveness in the biotechnology industry [1].

Core Viewpoint - The approval of two supplemental new drug applications for Selinexor (希维奥) by the Hong Kong Department of Health marks a significant milestone for Dechra Pharmaceuticals-B (德琪医药-B), enhancing its market presence and competitiveness in the biopharmaceutical sector [1] Group 1: Company Developments - Dechra Pharmaceuticals-B's stock rose nearly 6%, with a current price of 4.34 HKD and a trading volume of 9.4944 million HKD [1] - The approved applications are for the treatment of multiple myeloma (in combination with Bortezomib and Dexamethasone for adult patients who have received at least one prior therapy) and relapsed or refractory diffuse large B-cell lymphoma (as a monotherapy for adults who have undergone at least two lines of systemic therapy and are not candidates for hematopoietic stem cell transplantation) [1] Group 2: Market Implications - The approvals signify Dechra Pharmaceuticals-B's further expansion in the Hong Kong market, which is crucial for the company's business development [1] - The launch of Selinexor is expected to meet the treatment needs for relevant diseases in the Hong Kong market, thereby enhancing the company's competitiveness in the biotechnology industry [1]

Core Viewpoint - The approval of two supplemental new drug applications for Selinexor (希维奥) by the Hong Kong Department of Health marks a significant expansion for the company in the Hong Kong market, enhancing its competitiveness in the biopharmaceutical industry [1] Group 1: Company Developments - The stock price of Dechra Pharmaceuticals-B (德琪医药-B) increased by approximately 6%, reaching HKD 4.34, with a trading volume of HKD 9.4944 million [1] - The approved applications are for the treatment of multiple myeloma (in combination with bortezomib and dexamethasone for adult patients who have received at least one prior therapy) and relapsed or refractory diffuse large B-cell lymphoma (as a monotherapy for adults who have undergone at least two lines of systemic therapy and are not eligible for hematopoietic stem cell transplantation) [1] Group 2: Industry Implications - The approval signifies the company's ongoing enhancement in research and market promotion capabilities within the biopharmaceutical sector [1] - The introduction of Selinexor is expected to meet the treatment needs for relevant diseases in the Hong Kong market, thereby improving the company's competitive position in the biotechnology industry [1]

Core Viewpoint - The Hong Kong government has approved two supplemental new drug applications (sNDA) for the drug Selinexor (希维奥) by the company, allowing its use in treating multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma [1] Group 1: Drug Approvals - The approval includes the use of Selinexor in combination with Bortezomib and Dexamethasone (XVd) for adult patients with multiple myeloma who have received at least one prior therapy [1] - Selinexor is also approved as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), specifically for those who have undergone at least two lines of systemic therapy and are not eligible for hematopoietic stem cell transplantation due to follicular lymphoma [1]

Core Viewpoint - The Hong Kong Special Administrative Region Government's Department of Health has approved two supplemental new drug applications (sNDA) for the drug Xivio (Selinexor) [1] Group 1: Drug Approvals - Xivio is approved for use in combination with Bortezomib and Dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy [1] - Xivio is also approved as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), specifically for those who have received at least two lines of systemic therapy and are not candidates for hematopoietic stem cell transplantation due to follicular lymphoma [1]

Core Viewpoint - The Hong Kong government has approved two supplemental new drug applications (sNDA) for DQ Biotech-B (06996.HK) regarding its drug, Xivio® (Selinexor), for treating multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma [1] Group 1: Drug Approvals - Xivio® is approved for use in combination with bortezomib and dexamethasone (XVd) for adult patients with multiple myeloma (MM) who have received at least one prior treatment [1] - Xivio® is also approved as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), specifically those who have undergone at least two lines of systemic therapy and are not eligible for hematopoietic stem cell transplantation due to follicular lymphoma [1]

（股份代號：6996） 自願公告 希維奧®在香港獲批用於治療多發性骨髓瘤 及瀰漫大B細胞淋巴瘤兩種新增適應症 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 （於開曼群島註冊成立的有限公司） 德琪醫藥有限公司（簡稱「德琪醫藥」，香港交易所股票代碼：6996.HK）是一家以 研發為驅動的全球商業化階段生物科技公司，專注於開發治療具有未獲滿足的大 量醫療需求的疾病的同類首款和同類最優療法。其產品管線涵蓋臨床前階段到商 業化階段並包括多個內部開發項目，當中包括ATG-022（CLDN18.2抗體藥物偶聯 物）、ATG-037（口服CD73抑制劑）、ATG-101（PD-L1 × 4-1BB雙特異性抗體）、 ATG-031（靶向CD24巨噬細胞激活劑）及ATG-042（口服PRMT5-MTA抑制劑）。 德琪醫藥亦開發了AnTenGager™，其為專有的T細胞銜接器2.0平台，具有「 ...

Core Viewpoint - The Hong Kong pharmaceutical stocks experienced a significant downturn, with notable declines in several companies' stock prices [1] Group 1: Company Performance - Gilead Sciences (歌礼制药-B) saw a drop of over 8% in its stock price [1] - Sanofi (圣诺医药-B) experienced a decline of more than 6% [1] - Deciphera Pharmaceuticals (德琪医药-B) fell by over 4% [1] - Other companies such as Innovent Biologics (复宏汉霖) and Antengene Corporation (药捷安康-B) also followed the downward trend [1]

Core Viewpoint - The approval of the investigational new drug (IND) application for ATG-022, a CLDN18.2 antibody-drug conjugate, in combination with MSD's KEYTRUDA® and chemotherapy, marks a significant advancement in cancer treatment options [1] Group 1 - The National Medical Products Administration of China has approved the IND application for ATG-022 [1] - ATG-022 will be evaluated in a Phase Ib/II clinical trial (CLINCH-2) in combination with KEYTRUDA® and chemotherapy [1] - The collaboration with MSD (Merck & Co., Inc.) highlights the strategic partnership in developing innovative cancer therapies [1]

Core Viewpoint - The approval of the investigational new drug (IND) application for ATG-022, a CLDN18.2 antibody-drug conjugate, in combination with MSD's KEYTRUDA® and chemotherapy, marks a significant advancement in cancer treatment research [1] Group 1: Company Developments - The China National Medical Products Administration (NMPA) has approved the IND application for ATG-022 in conjunction with KEYTRUDA® and chemotherapy [1] - The clinical study, named CLINCH-2, is an Ib/II phase trial aimed at evaluating the efficacy of the combination therapy [1]