Latest news with #InnoCarePharma
Yahoo
21-05-2025
- Business
- Yahoo
InnoCare Announces the Approval of Minjuvi® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China
BEIJING, May 21, 2025--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. "The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR)," said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. "The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients." "The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL," said Professor Weili Zhao from Shanghai Ruijin Hospital. "We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo'ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy." Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "Today's approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China." Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo'ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases1. About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. In the United States, Monjuvi® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Hematology Branch of Chinese Medical Association View source version on Contacts Media Chunhua Lu86+ Investors 86+10-66609999ir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
21-05-2025
- Health
- Business Wire
InnoCare Announces the Approval of Minjuvi ® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China
BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi ® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. Minjuvi® (tafasitamab) is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. 'The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR),' said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. 'The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.' 'The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL,' said Professor Weili Zhao from Shanghai Ruijin Hospital. 'We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo'ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.' Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, 'Today's approval marks another important milestone for InnoCare as we will celebrate our 10 th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China.' Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo'ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases 1. About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are registered trademarks of Incyte. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Hematology Branch of Chinese Medical Association
Yahoo
20-05-2025
- Business
- Yahoo
Asian Equity Selections Possibly Priced Below Valuation Benchmarks For May 2025
As the Asian markets respond positively to the recent easing of U.S.-China trade tensions, investors are keenly observing opportunities that may arise from this temporary truce. In such an environment, identifying stocks potentially priced below their intrinsic value could offer strategic advantages, especially when these equities are positioned to benefit from improved economic relations and reduced tariff pressures. Name Current Price Fair Value (Est) Discount (Est) Ficont Industry (Beijing) (SHSE:605305) CN¥26.43 CN¥52.51 49.7% H.U. Group Holdings (TSE:4544) ¥3024.00 ¥5994.30 49.6% GEM (SZSE:002340) CN¥6.23 CN¥12.46 50% Kolmar Korea (KOSE:A161890) ₩84500.00 ₩168491.96 49.8% Dive (TSE:151A) ¥921.00 ¥1813.08 49.2% Heartland Group Holdings (NZSE:HGH) NZ$0.83 NZ$1.64 49.4% ALUX (KOSDAQ:A475580) ₩10640.00 ₩21018.68 49.4% Medley (TSE:4480) ¥3110.00 ¥6174.60 49.6% Innovent Biologics (SEHK:1801) HK$55.30 HK$109.45 49.5% InnoCare Pharma (SEHK:9969) HK$10.60 HK$21.19 50% Click here to see the full list of 300 stocks from our Undervalued Asian Stocks Based On Cash Flows screener. Here's a peek at a few of the choices from the screener. Overview: Hyundai Rotem Company manufactures and sells railway vehicles, defense systems, and plants and machinery in South Korea and internationally with a market cap of ₩12.41 trillion. Operations: The company's revenue is derived from three main segments: Eco Plant at ₩477.99 million, Rail Solution at ₩1.62 billion, and Defense Solution at ₩2.71 billion. Estimated Discount To Fair Value: 30.9% Hyundai Rotem is trading at ₩113,700, significantly below its estimated fair value of ₩164,460.31. Despite recent share price volatility, the company shows strong fundamentals with earnings having grown 156.6% last year and a forecasted annual growth of 20.03%. While revenue growth is expected at 12.5% per year—faster than the Korean market's 7.6%—analysts anticipate a potential stock price increase of 30.9%. Upon reviewing our latest growth report, Hyundai Rotem's projected financial performance appears quite optimistic. Dive into the specifics of Hyundai Rotem here with our thorough financial health report. Overview: InnoCare Pharma Limited is a biopharmaceutical company focused on discovering, developing, and commercializing drugs for cancer and autoimmune diseases in China, with a market cap of HK$22.27 billion. Operations: The company's revenue primarily comes from its pharmaceuticals segment, which generated CN¥1.01 billion. Estimated Discount To Fair Value: 50% InnoCare Pharma is trading at HK$10.6, significantly below its estimated fair value of HK$21.19, suggesting it may be undervalued based on cash flows. Despite a net loss of CNY 440.63 million in 2024, earnings have grown annually by 28.9% over the past five years and are forecast to increase by 58.85% per year moving forward. Recent clinical advancements in treatments like Soficitinib and Mesutoclax highlight potential revenue growth opportunities exceeding market averages. The growth report we've compiled suggests that InnoCare Pharma's future prospects could be on the up. Navigate through the intricacies of InnoCare Pharma with our comprehensive financial health report here. Overview: Singapore Technologies Engineering Ltd is a global technology, defence, and engineering company with a market cap of SGD23.41 billion. Operations: The company's revenue is primarily derived from three segments: Commercial Aerospace with SGD4.44 billion, Urban Solutions & Satcom generating SGD2.01 billion, and Defence & Public Security contributing SGD4.97 billion. Estimated Discount To Fair Value: 22.4% Singapore Technologies Engineering is trading at S$7.5, below its estimated fair value of S$9.67, highlighting potential undervaluation based on cash flows. With forecasted revenue growth of 7.4% annually and earnings growth outpacing the Singapore market at 12.5%, the company shows promising financial prospects despite high debt levels. Recent contract wins totaling S$4.4 billion across various segments could bolster future cash flows, though immediate impact on net tangible assets per share is minimal. In light of our recent growth report, it seems possible that Singapore Technologies Engineering's financial performance will exceed current levels. Click here to discover the nuances of Singapore Technologies Engineering with our detailed financial health report. Dive into all 300 of the Undervalued Asian Stocks Based On Cash Flows we have identified here. Invested in any of these stocks? Simplify your portfolio management with Simply Wall St and stay ahead with our alerts for any critical updates on your stocks. Streamline your investment strategy with Simply Wall St's app for free and benefit from extensive research on stocks across all corners of the world. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include KOSE:A064350 SEHK:9969 and SGX:S63. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
16-05-2025
- Health
- Yahoo
InnoCare Announces First Patient Dosed in the Phase II/IIII Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Vitiligo in China
BEIJING, May 16, 2025--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the Phase II/III clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with non-segmental vitiligo in China. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including vitiligo, atopic dermatitis (AD), prurigo nodularis, etc., with broad market potential. TYK2 is a non-receptor tyrosine kinase and a member of the JAK kinase family. It plays a key role in the JAK-STAT signaling pathway and is critically involved in the pathogenesis of inflammatory diseases. Vitiligo happens when skin melanocytes are destroyed, leading to loss of pigment, and leaving white patches on the skin. Vitiligo affects approximately 0.5%–2%1 of the global population. It is a chronic condition that requires long-term treatment. The goals of therapy include disease stabilization, repigmentation, and maintenance treatment to prevent recurrence of depigmentation. Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, "Vitiligo imposes significant psychological and social burdens on patients. Many patients experience decreased self-confidence, social barriers, and other challenges. There remains a lack of effective treatments, highlighting substantial unmet medical needs. We will accelerate the clinical development of soficitinib and look forward to bringing benefits to patients with vitiligo and other autoimmune diseases as early as possible." In addition to vitiligo, the clinical development of soficitinib for other autoimmune diseases is also progressing, including the Phase III registrational trial for atopic dermatitis. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Shanghai Municipal Health Commission View source version on Contacts MediaChunhua Investors86-10-66609999ir@
Associated Press
20-03-2025
- Business
- Associated Press
InnoCare Announces First Patient Dosed in the Phase III Registrational Trial of ICP-488 for the Treatment of Psoriasis in China
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the Phase III registrational trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-488, for the treatment of moderate-to-severe plaque psoriasis in China. This is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study, designed to evaluate the efficacy and safety of ICP-488 monotherapy in adult patients with moderate-to-severe plaque psoriasis. ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. According to the data presented at the Late-breaking Research session of the 2025 American Academy of Dermatology (AAD) Annual Meeting, the Phase II study results demonstrated that ICP-488 is highly effective in treating psoriasis at both 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for patients with moderate-to-severe psoriasis. Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, 'Psoriasis severely affects patients' quality of life and requires safer, more effective oral medications. We are pleased that ICP-488 has received recognition at international academic conferences for its promising clinical data, and we will accelerate the Phase III clinical program. In addition to psoriasis, InnoCare is rapidly advancing several Phase III registration trials in the field of autoimmune diseases. We look forward to bringing our innovative therapies to more patients around the world.' Recent data indicates that approximately 8.66 million people in China are currently living with psoriasis 1, and this number is on the rise 2. Existing treatment options do not fully address the needs of psoriasis patients, with particularly high demand for novel, oral medications. About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. 1 Epidemiological Burden Analysis of Psoriasis in China Based on the Global Burden of Disease (GBD) Big Data [J]. Chinese Journal of Dermatovenereology, 2021. 2 2021. Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021. Chunhua Lu 86-10-66609879 KEYWORD: CHINA ASIA PACIFIC INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY SOURCE: InnoCare Pharma Copyright Business Wire 2025. PUB: 03/20/2025 07:39 AM/DISC: 03/20/2025 07:40 AM
