--- title: "BIOSTAR PHARM-B intensively releases pipeline value signals: Four studies of Uteplizumab are set to debut at ASCO 2026, and innovative drugs in synthetic biology enter the global validation phase" type: "News" locale: "en" url: "https://longbridge.com/en/news/287999414.md" description: "BIOSTAR PHARM-B announced that the results of four clinical studies of its core product Uteribulin will be presented at the 2026 ASCO Annual Meeting, covering areas such as breast cancer, ovarian cancer, and prostate cancer. The studies show that Uteribulin performs excellently across various indications, marking the company's transformation from Biotech to Biopharma. This presentation has gained recognition in the academic community, indicating the market potential and innovative value of its products" datetime: "2026-05-29T02:37:10.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/287999414.md) - [en](https://longbridge.com/en/news/287999414.md) - [zh-HK](https://longbridge.com/zh-HK/news/287999414.md) --- # BIOSTAR PHARM-B intensively releases pipeline value signals: Four studies of Uteplizumab are set to debut at ASCO 2026, and innovative drugs in synthetic biology enter the global validation phase ——From "single variety commercialization" to "multi-indication globalization," BIOSTAR PHARM-B is completing a key leap from Biotech to Biopharma. **I. Core Event: Four Clinical Data Presentations at ASCO, Accelerating the Value Realization of UTD Platform** BIOSTAR PHARM-B recently released a voluntary announcement that four clinical research results of its core products, UTD1 injection and UTD2 capsules, have been selected for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The relevant results will be disclosed globally in the field of oncology treatment in Chicago from May 29 to June 2. These four studies cover major unmet needs in breast cancer, ovarian cancer, prostate cancer, and several key indicators are quite impressive: **Indication/Regimen** **Phase** **Key Readouts** UTD2 capsules for treating advanced breast cancer Phase II ORR **52.3%**, DCR **88.6%**, mPFS **8.25 months** UTD2 capsules + Furmonertinib for treating platinum-resistant recurrent ovarian cancer Phase II ORR **64.3%**, DCR **100%**, mPFS **7 months**, safety controllable UTD1 injection + Inotuzumab + Pyrotinib for treating HER2+ advanced breast cancer Phase II ORR **82.4%**, mPFS **13.1 months**, good OS rate performance UTD1 injection monotherapy for treating castration-resistant prostate cancer Phase II PSA50 response rate **23.3%**, rPFS 6.7 months, mOS 11.4 months Interpretation Points: ASCO is the "Oscar" of the global oncology community, and being able to present at the annual meeting means the data has been recognized by the academic community. More importantly, these four studies **are not mere tweaks for a single indication, but rather evidence of the "platform expansion" of UTD as a new class of microtubule inhibitors (derived from Epothilone): from injection to oral capsule formulation upgrade, from single tumor type in breast cancer to horizontal expansion across multiple tumor types, and from monotherapy to combination regimens, all three paths are blooming simultaneously.** **II. Why is this pipeline worth serious attention? — The "Differentiated Moat" of UTD** The market often tends to categorize domestic innovative drugs as "me-too internal competition," but BIOSTAR PHARM-B's UTD is a truly rare First-in-Class/Category-defining asset developed in China: Unique Mechanism: UTD is a derivative of Epothilone sourced from natural products of myxobacteria, achieving industrial production through synthetic biology genetic engineering breeding and fermentation processes — this route itself is a barrier The company has obtained the US PCT patent authorization covering its key technologies in synthetic biology and genetic engineering bacteria, with a solid global layout of intellectual property. Validated commercial starting point: UTD1 (injectable form, trade name: YouTiDi) received NMPA approval for its first indication, advanced breast cancer, in March 2021, making it the first and currently the only approved epothilone-based anti-tumor drug in China, classified as a national Class 1 innovative drug and a "major new drug creation" special achievement. Oral capsules break the ceiling: Phase II data for UTD2 (capsule form) show efficacy that is not inferior to, and may even exceed, that of the injectable form, while also demonstrating superior safety and significantly improved compliance—this is of great significance for long-term medication in cancer patients and is a core variable for opening the outpatient market and enhancing peak sales expectations. **Three, Global Clinical Chess Game: From "Going Abroad Narrative" to Substantive Regulatory Progress** If the data presentation at ASCO is a validation from the "academic side," then the company's progress on the regulatory and clinical operation sides is equally noteworthy: The FDA has approved the UTD2 combination regimen for first-line treatment of advanced gastric cancer in a Phase II/III international multicenter registration clinical trial, with the first patient dosing completed—this is a true registration study pathway, not an exploratory Phase I, indicating that HuaHao ZhongTian is advancing US market access under a rigorous NDA-level framework. The UTD1 combination with capecitabine for treating HER2-negative breast cancer brain metastases has completed the first patient dosing in a key US registration clinical trial—breast cancer brain metastases represent a typical "no treatment available" blind spot, and if successful, it will have a clear position in the second-line setting, with pricing logic at the Orphan Drug level. This project was previously selected as one of the "Top Ten Studies in Breast Cancer for 2025." The Phase II/III international multicenter clinical trial for UTD2 treating platinum-resistant ovarian cancer has also initiated patient dosing—platinum-resistant ovarian cancer is one of the most challenging scenarios for gynecological oncologists. These are not "PPT pipelines," but real registration clinical trials running in the US with actual financial backing. **Four, Positive Signals from the Capital Side: Strategic Shareholder Increase + Proposed Buyback, Dual "Voting with Feet" Confidence Expression** Another noteworthy recent news is that Baiyang subscribed for HKD 100 million to become a strategic shareholder holding 7.49% of HuaHao ZhongTian, and the relationship between the two has upgraded from "cornerstone investor/promotional cooperation" to covering ADC platform construction + innovative project transformation. Baiyang is not just a simple financial PE—it has a mature prescription drug commercialization network and hospital channels, and its increase in capital essentially endorses the product YouTiDi's volume curve + the commercialization potential of subsequent pipelines. The use of raised funds is clearly directed towards accelerating the development of the ADC technology platform and international cooperation. At the same time, the company's board has resolved to propose a buyback of no more than 10% of the total issued H shares in the open market, with a straightforward reason—"to demonstrate the company's confidence in its business outlook and prospects" and "existing financial resources are sufficient to support the buyback while maintaining stability." In the current environment where the Hong Kong stock 18A sector is generally under pressure, daring to propose a buyback itself is a rare attitude **V. How to View the Financial Aspect? - The "Efficiency Turning Point" Behind the Narrowing Losses** Full-year data for 2025: Revenue of 33.364 million yuan, net loss of 131 million yuan, but losses narrowed by 8.6% year-on-year, and R&D expenses decreased by 28.6% year-on-year (from 116 million to approximately 83 million), which is not a reduction in innovation investment, but rather a structural improvement brought about by optimized clinical advancement pace + government subsidies and other non-operating factors. For Biotech companies in the "single listed product volume × multi-pipeline clinical advancement" stage, key financial indicators are never about current profitability, but rather: (1) Is the cash runway sufficient? - Cash and cash equivalents are approximately 457 million yuan; (2) Is the core product in a growth channel? - The volume increase of Yutiandi in hospitals + expansion of new indications are the main drivers; (3) Is the next catalytic node clear? - ASCO 2026 presentation, international clinical advancement of gastric cancer phase II/III, key clinical trials for brain metastasis, and progress on the ADC platform constitute a dense catalyst matrix for the next 12 months. **VI. Conclusion: What is the Market Underestimating?** The reality facing Huahao Zhongtian is that as an 18A target, it is caught in the double squeeze of shrinking liquidity in the Hong Kong stock market and a gloomy sentiment in the innovative drug sector (the stock price hovers around 4 HKD, with a market value of approximately 1.3 billion HKD and low investment bank coverage). However, from a fundamental perspective, the narrative of this company is precisely moving towards "anti-involution": It is not a multitude of PD-1s crossing a narrow bridge, but rather an innovative drug developed in China that has established a diversified global clinical layout for breast cancer → ovarian cancer → gastric cancer → prostate cancer → brain metastasis, leveraging synthetic biology barriers, and has successively obtained FDA registration pathway green lights and data certifications from top academic conferences. The four posters at ASCO 2026 are merely a "phase performance report." What is truly worth tracking is whether the UTD2 oral formulation can produce registrational data in key indications, whether Baiyang's commercialization empowerment can push Yutiandi into an accelerated volume growth phase, and whether the ADC platform can incubate the next differentiated molecule. For investors willing to examine the value of innovative drugs from a 12-24 month perspective, the current pipeline visibility of Huahao Zhongtian may have already exceeded the market expectations reflected in its market value ### Related Stocks - [02563.HK](https://longbridge.com/en/quote/02563.HK.md) - [300839.CN](https://longbridge.com/en/quote/300839.CN.md) ## Related News & Research - [Beijing Biostar Pharmaceuticals Plans Discretionary H-Share Buy-Back to Signal Confidence](https://longbridge.com/en/news/285579919.md) - [CStone’s CS2009 Posts Strong ASCO Data as Company Prepares Global Phase III Trial](https://longbridge.com/en/news/288238438.md) - [A Look At Sichuan Kelun-Biotech Biopharmaceutical’s (SEHK:6990) Valuation After Positive 2026 ASCO Lung Cancer Data](https://longbridge.com/en/news/289004316.md) - [](https://longbridge.com/en/news/288700390.md) - [Hengrui Pharma Presents More Than 90 Oncology Studies at ASCO 2026, Highlighting Progress Across Multiple Tumor Types](https://longbridge.com/en/news/289034709.md)