Latest news with #AlphamabOncology
Yahoo
04-08-2025
- Business
- Yahoo
Alphamab Oncology Announces IND Application for Innovative PD-L1/αvβ6 Bispecific ADC JSKN022 was Officially Accepted by CDE
SUZHOU, China, Aug. 4, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: announced that the Investigational New Drug (IND) application for JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a first-in-human (FIH) clinical study of JSKN022 for the treatment of advanced malignant solid tumors. JSKN022 is an innovative bispecific ADC developed in-house with Alphamab's proprietary glycan-specific conjugation platform. The molecule simultaneously targets and binds to both PD-L1 and integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The cleavable linker is specifically hydrolyzed by proteolytic enzymes such as cathepsin B, releasing cytotoxic topoisomerase I inhibitor (T01), which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effects. These combined effects can effectively inhibit the growth of tumor cells. At present, no ADC targeting integrin αvβ6 or PD-L1 has been approved for marketing worldwide, with all related investigational candidates remaining in clinical development stages. Preclinical data demonstrate that JSKN022 exhibits potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1. JSKN022 will potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer. This Phase I clinical study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). About JSKN022JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes glycan-specific conjugation technology to enhance both stability and homogeneity. The topoisomerase I inhibitor T01 is site-specifically conjugated to antibodies via a cleavable linker, enhancing therapeutic efficacy. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors. The IND application for the first-in-human clinical study of JSKN022 for the treatment of advanced malignant solid tumors has been accepted by CDE. About Alphamab OncologyAlphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. On December 12, 2019, the Company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966. By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. View original content: SOURCE Alphamab Oncology Sign in to access your portfolio
Yahoo
29-07-2025
- Business
- Yahoo
Undiscovered Gems in Asia for July 2025
Amidst a backdrop of mixed performances in global indices, with the small-cap Russell 2000 showing positive movement while other midcap indices falter, the Asian markets are offering intriguing opportunities for discerning investors. In this dynamic environment, identifying stocks that demonstrate resilience and potential for growth becomes essential, particularly those that can navigate economic shifts and capitalize on regional strengths. Top 10 Undiscovered Gems With Strong Fundamentals In Asia Name Debt To Equity Revenue Growth Earnings Growth Health Rating Ampire NA -2.21% 8.00% ★★★★★★ Orient Pharma 17.16% 26.65% 68.11% ★★★★★★ Oriental Precision & EngineeringLtd 39.11% 5.91% 0.76% ★★★★★☆ E J Holdings 21.62% 4.30% 3.77% ★★★★★☆ Tokyo Tekko 8.47% 8.06% 24.39% ★★★★★☆ Zhejiang Jinghua Laser TechnologyLtd 2.85% 4.02% -2.43% ★★★★★☆ Uju Holding 33.18% 8.01% -15.93% ★★★★★☆ Iljin DiamondLtd 2.55% -3.23% 0.91% ★★★★☆☆ Shenzhen Leaguer 63.12% 1.96% -16.52% ★★★★☆☆ ASRock Rack Incorporation 77.35% 311.61% 693.05% ★★★★☆☆ Click here to see the full list of 2605 stocks from our Asian Undiscovered Gems With Strong Fundamentals screener. We're going to check out a few of the best picks from our screener tool. Alphamab Oncology Simply Wall St Value Rating: ★★★★★☆ Overview: Alphamab Oncology is a clinical stage biopharmaceutical company focused on the research, development, manufacture, and commercialization of oncology biologics with a market cap of HK$9.03 billion. Operations: The company generates revenue primarily from its pharmaceuticals segment, amounting to CN¥640.08 million. Alphamab Oncology, a small player in the biotech space, has turned profitable this year and is trading at 77.8% below its estimated fair value. Despite a volatile share price recently, the company shows promise with its innovative treatments like JSKN003 for advanced tumors and KN026 for HER2-positive cancers. The debt to equity ratio slightly rose from 9.5 to 9.9 over five years, but it still holds more cash than total debt, indicating financial stability. Recent executive changes bring experienced leadership on board as Alphamab positions itself for future growth in the competitive biotech industry. Click here to discover the nuances of Alphamab Oncology with our detailed analytical health report. Review our historical performance report to gain insights into Alphamab Oncology's's past performance. Guangdong Orient Zirconic Ind Sci & TechLtd Simply Wall St Value Rating: ★★★★★☆ Overview: Guangdong Orient Zirconic Ind Sci & Tech Co., Ltd focuses on the research, development, production, and sale of zirconium products with a market capitalization of CN¥10.61 billion. Operations: The company generates revenue primarily from producing and selling titanium ore, zirconium series products, and structural ceramics, with total sales reaching CN¥1.40 billion. Guangdong Orient Zirconic, a nimble player in the chemical sector, has seen its debt to equity ratio improve significantly from 129% to 39% over five years. Trading at nearly 90% below estimated fair value, it seems undervalued by market standards. Despite recent volatility in its share price, the company turned profitable this year and boasts high-quality earnings. The net debt to equity ratio stands at a satisfactory 10%, indicating prudent financial management. Recent amendments to its articles of association suggest strategic shifts that may influence future operations positively or negatively depending on execution and market conditions. Take a closer look at Guangdong Orient Zirconic Ind Sci & TechLtd's potential here in our health report. Evaluate Guangdong Orient Zirconic Ind Sci & TechLtd's historical performance by accessing our past performance report. Yangzhou Seashine New MaterialsLtd Simply Wall St Value Rating: ★★★★★★ Overview: Yangzhou Seashine New Materials Co., Ltd. specializes in the design, production, and marketing of powder metallurgy structural parts in China with a market cap of CN¥4.62 billion. Operations: Yangzhou Seashine generates revenue primarily from the sale of powder metallurgy structural parts. The company's financial performance is impacted by its cost structure, which includes expenses related to production and marketing. Yangzhou Seashine New Materials, a small player in the Asian market, has shown impressive performance with earnings growth of 33.6% over the past year, outpacing its industry peers. Despite a volatile share price recently, this company remains debt-free for five years and boasts high-quality earnings. Its free cash flow turned positive at CNY 70.54 million by the end of 2024, reflecting efficient capital management with capital expenditure dropping to CNY 9.01 million. Revenue is projected to grow annually by 21.43%, indicating promising future prospects amidst recent dividend increases for shareholders in June 2025. Click to explore a detailed breakdown of our findings in Yangzhou Seashine New MaterialsLtd's health report. Gain insights into Yangzhou Seashine New MaterialsLtd's historical performance by reviewing our past performance report. Where To Now? Dive into all 2605 of the Asian Undiscovered Gems With Strong Fundamentals we have identified here. Are you invested in these stocks already? Keep abreast of every twist and turn by setting up a portfolio with Simply Wall St, where we make it simple for investors like you to stay informed and proactive. Invest smarter with the free Simply Wall St app providing detailed insights into every stock market around the globe. Interested In Other Possibilities? Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. 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 SEHK:9966 SZSE:002167 and SZSE:300885. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
Yahoo
25-07-2025
- Business
- Yahoo
Undiscovered Gems in Asia for July 2025
Amidst a backdrop of mixed performances in global indices, with the small-cap Russell 2000 showing positive movement while other midcap indices falter, the Asian markets are offering intriguing opportunities for discerning investors. In this dynamic environment, identifying stocks that demonstrate resilience and potential for growth becomes essential, particularly those that can navigate economic shifts and capitalize on regional strengths. Top 10 Undiscovered Gems With Strong Fundamentals In Asia Name Debt To Equity Revenue Growth Earnings Growth Health Rating Ampire NA -2.21% 8.00% ★★★★★★ Orient Pharma 17.16% 26.65% 68.11% ★★★★★★ Oriental Precision & EngineeringLtd 39.11% 5.91% 0.76% ★★★★★☆ E J Holdings 21.62% 4.30% 3.77% ★★★★★☆ Tokyo Tekko 8.47% 8.06% 24.39% ★★★★★☆ Zhejiang Jinghua Laser TechnologyLtd 2.85% 4.02% -2.43% ★★★★★☆ Uju Holding 33.18% 8.01% -15.93% ★★★★★☆ Iljin DiamondLtd 2.55% -3.23% 0.91% ★★★★☆☆ Shenzhen Leaguer 63.12% 1.96% -16.52% ★★★★☆☆ ASRock Rack Incorporation 77.35% 311.61% 693.05% ★★★★☆☆ Click here to see the full list of 2605 stocks from our Asian Undiscovered Gems With Strong Fundamentals screener. We're going to check out a few of the best picks from our screener tool. Alphamab Oncology Simply Wall St Value Rating: ★★★★★☆ Overview: Alphamab Oncology is a clinical stage biopharmaceutical company focused on the research, development, manufacture, and commercialization of oncology biologics with a market cap of HK$9.03 billion. Operations: The company generates revenue primarily from its pharmaceuticals segment, amounting to CN¥640.08 million. Alphamab Oncology, a small player in the biotech space, has turned profitable this year and is trading at 77.8% below its estimated fair value. Despite a volatile share price recently, the company shows promise with its innovative treatments like JSKN003 for advanced tumors and KN026 for HER2-positive cancers. The debt to equity ratio slightly rose from 9.5 to 9.9 over five years, but it still holds more cash than total debt, indicating financial stability. Recent executive changes bring experienced leadership on board as Alphamab positions itself for future growth in the competitive biotech industry. Click here to discover the nuances of Alphamab Oncology with our detailed analytical health report. Review our historical performance report to gain insights into Alphamab Oncology's's past performance. Guangdong Orient Zirconic Ind Sci & TechLtd Simply Wall St Value Rating: ★★★★★☆ Overview: Guangdong Orient Zirconic Ind Sci & Tech Co., Ltd focuses on the research, development, production, and sale of zirconium products with a market capitalization of CN¥10.61 billion. Operations: The company generates revenue primarily from producing and selling titanium ore, zirconium series products, and structural ceramics, with total sales reaching CN¥1.40 billion. Guangdong Orient Zirconic, a nimble player in the chemical sector, has seen its debt to equity ratio improve significantly from 129% to 39% over five years. Trading at nearly 90% below estimated fair value, it seems undervalued by market standards. Despite recent volatility in its share price, the company turned profitable this year and boasts high-quality earnings. The net debt to equity ratio stands at a satisfactory 10%, indicating prudent financial management. Recent amendments to its articles of association suggest strategic shifts that may influence future operations positively or negatively depending on execution and market conditions. Take a closer look at Guangdong Orient Zirconic Ind Sci & TechLtd's potential here in our health report. Evaluate Guangdong Orient Zirconic Ind Sci & TechLtd's historical performance by accessing our past performance report. Yangzhou Seashine New MaterialsLtd Simply Wall St Value Rating: ★★★★★★ Overview: Yangzhou Seashine New Materials Co., Ltd. specializes in the design, production, and marketing of powder metallurgy structural parts in China with a market cap of CN¥4.62 billion. Operations: Yangzhou Seashine generates revenue primarily from the sale of powder metallurgy structural parts. The company's financial performance is impacted by its cost structure, which includes expenses related to production and marketing. Yangzhou Seashine New Materials, a small player in the Asian market, has shown impressive performance with earnings growth of 33.6% over the past year, outpacing its industry peers. Despite a volatile share price recently, this company remains debt-free for five years and boasts high-quality earnings. Its free cash flow turned positive at CNY 70.54 million by the end of 2024, reflecting efficient capital management with capital expenditure dropping to CNY 9.01 million. Revenue is projected to grow annually by 21.43%, indicating promising future prospects amidst recent dividend increases for shareholders in June 2025. Click to explore a detailed breakdown of our findings in Yangzhou Seashine New MaterialsLtd's health report. Gain insights into Yangzhou Seashine New MaterialsLtd's historical performance by reviewing our past performance report. Where To Now? Dive into all 2605 of the Asian Undiscovered Gems With Strong Fundamentals we have identified here. Are you invested in these stocks already? Keep abreast of every twist and turn by setting up a portfolio with Simply Wall St, where we make it simple for investors like you to stay informed and proactive. Invest smarter with the free Simply Wall St app providing detailed insights into every stock market around the globe. Interested In Other Possibilities? Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. 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 SEHK:9966 SZSE:002167 and SZSE:300885. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Yahoo
03-06-2025
- Business
- Yahoo
Alphamab Oncology Presented Multiple Clinical Data of Anti-HER2 Biparatopic ADC JSKN003 at the 2025 ASCO Annual Meeting
SUZHOU, China, June 3, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: announced that multiple clinical data updates for anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 were presented as posters at the 2025 Annual Meeting of American Society of Clinical Oncology (2025 ASCO Annual Meeting) from May 30 to June 3, 2025, in Chicago, IL, U.S.. The results covered platinum-resistant ovarian cancer, HER2-positive breast cancer, and HER2-overexpressing gastrointestinal tumors. Title: JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trialsAbstract Number for Publication: 5557Session Type and Title: Poster Session - Gynecologic CancerSession Date and Time: 6/1/2025 9:00 AM-12:00 PM CDTPresenter: Xiaohua Wu, Fudan University Shanghai Cancer Center Methods JSKN003-101 (NCT05494918) is a Phase I study in Australia and JSKN003-102 (NCT05744427) is a Phase I/II study in China. Both trials enrolled patients with advanced solid tumors who were to receive JSKN003 monotherapy at various dose levels. Pooled results have demonstrated that JSKN003 monotherapy has promising efficacy signals in patients with PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor. Preliminary data from the pooled analysis of these two studies were presented at the 2024 European Society for Medical Oncology (ESMO) Congress for the first time. The latest findings for non-primary platinum-refractory PROC patients at a longer follow-up time were reported at this ASCO Annual Meeting. Results As of February 28, 2025, 46 PROC patients were enrolled and received JSKN003 every three weeks across five doses levels, among which 2 patients at the dose of 4.2 mg/kg, 2 patients at the dose of 5.2 mg/kg, 40 patients at the dose of 6.3 mg/kg (RP2D), 1 patient at the dose of 7.3mg/kg, and 1 patient at the dose of 8.4mg/kg. Efficacy: With a median follow-up time of 9.3 months, 46 patients were efficacy evaluable. 42 patients (91.3%) exhibited tumor shrinkage. The objective response rate (ORR) was 63.0%, the median progression-free survival (PFS) was 7.7 months, and the 9-month overall survival (OS) rate was 89.9%. Efficacy was observed across different HER2-expression subgroups. The ORR was 52.4% and the median PFS was 6.6 months in patients with HER2 IHC 0. The ORR reached 72.2% and the median PFS was 9.4 months in patients with HER2 expression (IHC 1+/2+/3+). Safety: Grade 3-4 treatment-related adverse events (TRAEs) occurred in 9 patients (19.6%). Serious TRAEs were reported in 6 patients (13.0%). No TRAEs leading to death. Interstitial lung disease (ILD) was observed in 5 patients (10.9%), all were Grade 1/2. Conclusions With extended follow-up, JSKN003 demonstrated robust PFS improvement in PROC, along with early signals of OS benefit. A confirmatory trial (JSKN003-306, NCT06751485) is currently enrolling all comers regardless of HER2 expression to validate JSKN003 as a treatment option for this patient population. Title: JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studiesAbstract Number for Publication: 1028Session Type and Title: Poster Session - Breast Cancer - MetastaticSession Date and Time: 6/2/2025 9:00 AM-12:00 PM CDTPresenter: Yiqun Du, Fudan University Shanghai Cancer Center Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-positive (IHC 3+ or 2+/ISH+) advanced breast cancer from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, the median follow-up duration was 6.1 months. A total of 88 patients with HER2-positive breast cancer were enrolled, with the majority receiving 6.3 mg/kg or 8.4 mg/kg doses. The median age was 55 years (range: 32-79), with 77.3% ECOG PS 1. All patients had stage IV disease, with 76.1% having visceral metastases. All patients had prior anti-HER2 therapy, including 85.2% with prior ADCs or TKIs, and 55.7% having at least three prior lines treatment. Efficacy: A total of 80 T-DXd-naïve patients were enrolled, of whom 75 were evaluable for efficacy. In this population (N=75), JSKN003 demonstrated a confirmed ORR of 54.7% (95% CI: 42.7-66.2). The disease control rate (DCR) and clinical benefit rate (CBR) were 94.7% and 66.7%, respectively. Among 30 patients treated at the RP2D of 6.3 mg/kg, the confirmed ORR was 73.3%, and CBR reached 83.3%. Subgroup analyses by line of therapy showed ORRs of 66.7% in the prior first line group of 15 patients and 63.2% in the prior second line group of 19 patients, respectively. In addition, 8 patients who had previously received T-DXd were enrolled, among whom 7 had evaluable efficacy data. One patient achieved a partial response (PR), four had stable disease (SD), and tumor shrinkage was observed in four patients. These patients were analyzed separately for exploratory purposes. The median duration of response (DoR) in the overall population was 18.4 months (95% CI: 9.9-NE). Median PFS was not mature at the time of data cutoff. The 3-month and 6-month PFS rates were 88.4% (95% CI: 78.8–93.8) and 75.4% (95% CI: 62.3–84.4), respectively. Safety: 15.9% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 5.7% of patients. Dose reductions due to TRAEs occurred in 12.5% of patients, and one patient discontinued due to a TRAE. No TRAEs led to death. The most common TRAEs (≥20%) were nausea, increased alanine aminotransferase, decreased white blood cell count, vomiting, anemia, decreased appetite, thrombocytopenia, fatigue, neutropenia, and diarrhea. ILD was reported in 4 patients (4.5%), mostly Grade 1-2; one case was Grade 3. Conclusions JSKN003 demonstrated promising antitumor activity and manageable safety in heavily pretreated HER2-positive breast cancer, including patients previously treated with T-DXd. Its biparatopic HER2 antibody design may enhance target binding and contribute to the observed clinical benefit. A pivotal Phase III trial (JSKN003-301, NCT06846437) is ongoing to compare JSKN003 with T-DM1 in patients with HER2-positive advanced breast cancer who were previously treated with trastuzumab. Title: A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumorsAbstract Number for Publication: 3022Session Type and Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor BiologySession Date and Time: 6/2/2025 1:30 PM-4:30 PM CDTPresenter: Dan Liu, Beijing Cancer Hospital Methods The pooled analysis was performed to evaluate the efficacy and safety of JSKN003 in HER2-overexpressing (IHC 3+) metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJC) and colorectal cancer (CRC) patients from the Phase I clinical trial (JSKN003-101, NCT05494918) in Australia and the Phase I/II clinical trial (JSKN003-102, NCT05744427) in China. Results As of February 28, 2025, a total of 50 patients with HER2-overexpressing gastrointestinal tumors (27 patients in GC/GEJC and 23 patients in CRC) were enrolled and treated with JSKN003 monotherapy across 7 dose levels: 1 patient at the dose of 2.1 mg/kg, 1 patient at the dose of 4.2 mg/kg, 1 patient at the dose of 5.2 mg/kg, 43 patients at the dose of 6.3 mg/kg, 1 patient at the dose of 7.3 mg/kg, 2 patients at the dose of 8.4 mg/kg and 1 patient at the dose of 10.5 mg/kg. The median age was 60 years (range: 52-66), with 86.0% ECOG PS 1. Most patients were heavily pretreated: 38.0% had at least three lines of prior therapies, 68.0% received anti-HER2 therapy, 48.0% received Irinotecan. Efficacy: Among 48 patients who had at least one tumor assessment after baseline, JSKN003 demonstrated the ORR of 62.5% and the DCR was 93.8%. Among 27 patients with GC/GEJC, the ORR was 63.0% and DCR reached 92.6%. Among 21 patients with CRC, the ORR was 61.9% and DCR reached 95.2%. Among twenty patients with BRAF V600E-wild type, the ORR was 65.0%. Additionally, among 24 patients (4 patients in GC/GEJC and 20 patients in CRC) who were pretreated with irinotecan, the ORR achieved 58.3%. The median DoR in GC/GEJC patients was 9.6 months (95% CI: 3.0-NE), while the median DoR in CRC patients was 12.1 months (95% CI: 5.8-NE). Median PFS was 9.6 months (95%CI: 4.3, 11.6) with 70.4% PFS rate at 6 months in GC/GEJC patients. Median PFS was 13.8 months (95% CI: 6.8, NE) with 88.9% PFS rate at 6 months in CRC patients. Safety: 18.0% of patients experienced Grade 3 or higher TRAEs. Serious TRAEs were reported in 6.0% of patients. Dose reduction due to TRAEs occurred in 20.0% of patients and 16.3% at RP2D. No TEAEs led to discontinuation or death. The most common TRAEs (≥20%) were nausea, diarrhea, decreased appetite, decreased white blood cell count, anemia, fatigue, decreased neutrophil count, decreased platelet count and vomiting. ILD was reported in 3 patients (6.0%), with Grade 1 in 2 patients and Grade 2 in 1 patient. Conclusions JSKN003 demonstrated promising efficacy in heavily pretreated HER2-overexpressing (IHC3+) gastrointestinal tumors including patients previously treated with irinotecan, with a manageable and predictable safety profile. The HER2 biparatopic ADC design may contribute to the observed clinical benefit. About JSKN003 JSKN003 is a bispecific ADC developed based on KN026 using Alphamab's proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three Phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory Phase II clinical studies are currently undergoing smoothly. In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003. About Alphamab Oncology Alphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. View original content: SOURCE Alphamab Oncology Sign in to access your portfolio
Yahoo
29-05-2025
- Business
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Bispecific Antibody Drug Conjugates Clinical Trials Bispecific ADC Market Size Insight
Chinese Pharmaceutical Companies Dominating Global Research & Development Landscape Of Bispecific ADC Market Says Kuick Research In New Report Delhi, May 29, 2025 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals and Future Market Opportunity Outlook 2029 Report: Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates First Bispecific Antibody Drug Conjugates Commercial Approval Expected By 2029 Insight On Bispecific Antibody Drug Conjugates In Clinical Trials : > 60 Drug Conjugates China Dominating Bispecific Antibody Drug Conjugates Clinical Trials: > 35 Drug Conjugates Majority Of Bispecific Antibody Drug Conjugates For Breast Cancer Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase Bispecific Antibody Drug Conjugates In Combination Therapy By Indication and Clinical Phase Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates Download Report: Bispecific antibody drug conjugates (BsADCs) are an innovative class of therapeutics that combine the dual-targeting capabilities of bispecific antibodies with the cytotoxic payloads characteristic of traditional antibody drug conjugates (ADCs). Unlike conventional ADCs, which typically target a single antigen, BsADCs engage two different antigens simultaneously, enhancing specificity and efficacy against cancer cells. This unique mechanism enables BsADCs to not only deliver cytotoxic agents directly to the tumor site but also improve selectivity for cancer cells, potentially reducing off-target effects. The development of BsADCs is supported by various advanced technology platforms. For instance, Alphamab Oncology has developed a proprietary ADC platform that allows for the precise construction of bispecific constructs. Similarly, Bi-Cygni Therapeutics employs its BiVictriX platform to enhance the efficacy and safety profiles of its bispecific antibodies. Debiopharm's Multilink™ platform is another example that enables the creation of multifunctional biotherapeutics. These technology platforms play a crucial role in optimizing the design and development of BsADCs, streamlining the path from research to clinical application. One of the most advanced bispecific antibody drug conjugates currently in development is BL B01D1, created by Sichuan Baili Pharmaceutical and its subsidiary, SystImmune. This candidate is undergoing clinical trials in China, showcasing the country's rapid advancements in this therapeutic area. With a focus on addressing unmet medical needs, BL B01D1 exemplifies the potential of BsADCs to provide effective treatment options for patients facing challenging cancers. The ongoing trials will provide valuable data on its safety and efficacy, contributing to the broader understanding of bispecific therapies. China has emerged as a dominant force in the development of BsADCs, with a significant number of clinical trials underway. This landscape is marked by intense competition, as various companies strive to launch their candidates and establish themselves as leaders in this burgeoning field. Notable players include ABL Bio, Bristol Myers Squibb, Amgen, Debiopharm, Doma Bio, ProEn Therapeutics, AstraZeneca, and Innovent Biologics. Each of these companies is racing to bring their innovative therapies to market, aiming to be the first in their class. As the market for bispecific antibody drug conjugates becomes increasingly competitive, the ongoing research and development will likely yield numerous advancements that could redefine cancer treatment paradigms. The potential of BsADCs to deliver targeted therapy more effectively than conventional ADCs makes them an exciting prospect in oncology. With continued investment and innovation, these therapeutics could significantly improve patient outcomes, offering new hope in the fight against cancer. The landscape is rapidly evolving, and as clinical data emerges, the true impact of bispecific antibody drug conjugates will begin to take shape, highlighting their role in the future of cancer treatment. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ 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
