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Trastuzumab botidotin is a HER2-targeted ADC composed of a cytotoxic drug (Duostatin-5, anti-microtubule agent) with site-specific conjugation to trastuzumab via a stable protease-cleavable valine-citrulline linker. The unique linker is stable in plasma and selectively cleaved by lysosomal cathepsin B that is up-regulated in cancer cells.
In this study, a total of 365 patients with HER2+ unresectable or metastatic BC who had received at least one prior anti-HER2 therapy were randomized (1:1) to receive trastuzumab botidotin or T-DM1. 53% of patients had received ≥2 lines of anti-HER2 therapy, 61% of patients had HER2 Immunohistochemistry (IHC) 3+, and 60% of patients had been treated with TKIs, particularly pyrotinib (56%). As of April 26, 2025, median follow-up was 14.9 months.
Median PFS was significantly longer in trastuzumab botidotin than in T-DM1 (11.1 months vs 4.4 months; HR: 0.39, 95% CI, 0.30-0.51, p<0.0001). PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy (HR 0.36, 95% CI, 0.25-0.53, for 1 prior line; HR 0.39, 95% CI, 0.28-0.56, for ≥2 prior lines).
ORR by blinded independent central review (BICR) was 76.9% vs 53.0%.
A trend toward benefit in OS was observed in trastuzumab botidotin (HR 0.62; 95% CI, 0.38-1.03).
Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 69.8% of patients in trastuzumab botidotin and 63.7% in T-DM1. The most common TEAEs associated with dose reduction were ocular AEs for trastuzumab botidotin, and were platelet count decreased for trastuzumab emtansine. Only two patients permanently discontinued trastuzumab botidotin due to TEAE. No on-treatment deaths were observed in trastuzumab botidotin, compared with 1.6% in T-DM1, all of which were considered unrelated to treatment.
As a conclusion, this second head-to-head trial comparing T-DM1 with other anti-HER2 regimens demonstrated that trastuzumab botidotin statistically improved PFS with an ORR of 76.9% vs 53.0%. PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy. Ocular AEs were also manageable.
“Professor Xichun Hu, National Lead Principal Investigator from Fudan University Shanghai Cancer Center:”Trastuzumab botidotin effectively balances safety and efficacy through its unique molecular design, reducing the incidence of interstitial lung disease and hematologic toxicity. According to research data, trastuzumab botidotin demonstrated significant survival benefits in the pivotal Phase III trial, with an overall manageable safety profile, providing a new important treatment option for pretreated HER2+ BC patients. These positive results also offer robust evidence-based support for personalized treatment and updates to clinical practice guidelines.”
About Trastuzumab botidotin
Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.
Based on the results of a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study, trastuzumab botidotin was approved for marketing by the NMPA in for adult patients with unresectable or metastatic HER2 positive BC who have received one or more prior anti-HER2 therapy. At a pre-specified interim analysis, trastuzumab botidotin demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1[; the beneficial trend for OS of trastuzumab botidotin was also observed.
Currently, the Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 projects are in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 1 ADC project approved for marketing and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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AVITA Medical has appointed Cary Vance as Interim CEO following the sudden departure of Jim Corbett, along with a Board reshuffle. The company also announced preliminary third-quarter revenue guidance of about $17 million and is renegotiating financial covenants with OrbiMed.
See our latest analysis for AVITA Medical.
AVITA Medical’s share price has experienced a steep drop, with a 1-day return of -25.84% that extends a longer downtrend; its share price return is now down 68.8% year-to-date and the total shareholder return over the past year is -62.46%. Although new leadership and ongoing financial negotiations have triggered heightened volatility, these developments highlight how shifts in management and guidance can dramatically alter risk perceptions and momentum. Longer-term returns also remain deeply negative.
If recent leadership changes have you rethinking your portfolio, it’s worth broadening your search and discovering fast growing stocks with high insider ownership.
With the share price at multiyear lows and uncertainty clouding the outlook, investors now face a pivotal question: is AVITA Medical undervalued after recent events, or does the current price already reflect limited growth prospects?
Market watchers are comparing AVITA Medical’s last close of $3.99 to a narrative fair value estimate of $8.26 per share, highlighting a sharp disconnect between recent price action and what analysts believe the company is worth. The narrative points to several potential catalysts that could change the trajectory for AVITA and shift sentiment.
“Launch and rapid initial uptake of Cohealyx and PermeaDerm, supported by their integration with RECELL in a comprehensive wound care portfolio, positions AVITA to capture new indications and patient segments beyond burns (e.g., trauma), increasing the company’s total addressable market and diversifying future revenue streams.”
Read the complete narrative.
Want to know what bold growth assumptions power this deeply discounted fair value? Find out which future milestones and transformative launches could unlock the upside. The secret behind this projection is a set of aggressive profit margin and sales targets. What exactly are they?
Result: Fair Value of $8.26 (UNDERVALUED)
Have a read of the narrative in full and understand what’s behind the forecasts.
However, persistent Medicare reimbursement delays and continued reliance on RECELL for growth could significantly undermine the bullish narrative and extend uncertainty for investors.
Find out about the key risks to this AVITA Medical narrative.
Ingrid de Swart has been nominated to succeed Jos Baeten as CEO and Chair of the Executive Board (EB) of ASR Nederland N.V. (a.s.r.) following the end of his term at the Annual General Meeting (AGM) on 20 May 2026.
Joop Wijn, Chair of the SB of a.s.r., stated : “The Supervisory Board is delighted to nominate Ingrid de Swart as Chair of the Executive Board of a.s.r. Ingrid brings a unifying presence, the experience necessary to ensure continuity in a.s.r.’s strategy, and a forward-looking vision to drive the company’s sustainable growth.
“Although Jos Baeten’s departure will take place at a later date, we would already like to express our profound appreciation for everything he has contributed to a.s.r. over more than 45 years. His dedication and leadership have been invaluable. Under his guidance, a.s.r. successfully navigated the financial crisis, completed a successful IPO, achieved growth both organically and through acquisitions, and became one of the leading insurers in the Netherlands.”
Ingrid de Swart is a seasoned veteran of the financial services industry with over 28 years of experience. She has been a member of a.s.r’s EB since December 1, 2019, serving as COO/CTO, and playing a key role in the company’s strategic direction.
In addition, de Swart has been leading the integration of Aegon Nederland into a.s.r. since October 2022. Prior to joining a.s.r., she served as Chair of the Retail Division on the Statutory Board of Aegon Nederland. Her career also includes leadership roles at Delta Lloyd, and ABN AMRO Verzekeringen.
Jos Baeten, CEO of a.s.r., said: “I have had the privilege of leading a.s.r. for more than 20 years. To this day, I continue to do so with great energy and pleasure, and I will carry on until the AGM. I am very proud of what we have achieved with a.s.r.
“We have a strong team, a strategy focused on growth and a robust balance sheet making a.s.r. a company ready for the future. For me personally, the time has come to hand over the leadership. That is why I have informed the Supervisory Board that I am not available for a new term. I am pleased and proud that Ingrid is my intended successor.”
According to the announcement, Baeten who began his career at the company in 1980, will remain involved until his retirement on 1 December 2026.
The intended appointment of Ingrid de Swart is subject to approval by the regulators and vote at the upcoming AGM.
The a.s.r. Works Council has issued a positive recommendation, and the SB intends to proceed with the appointment for a period of four years.
a.s.r plans to address the EB vacancy arising from de Swart’s intended appointment at a later date/
This article first appeared on GuruFocus.
Revenue Growth: 7.6% increase in Q2 FY26, reaching INR 181.7 crores from INR 168.9 crores in Q1 FY26.
EBITDA: Increased by 7.1% to INR 43.6 crores in Q2 FY26 from INR 40.7 crores in Q1 FY26, with an EBITDA margin of 24.0%.
Domestic Formulation Business Growth: 17.2% growth in Q2 FY26 over Q2 FY25, outpacing the Indian pharmaceutical market growth of 7.7%.
H1 Revenue Growth: 3.8% increase over H1 last year.
Net Cash Surplus: Approximately INR 223 crores, maintaining a debt-free status.
Naprosyn Brand Growth: 16% year-over-year growth in H1 FY26, on track to become the first INR 100 crore brand.
Immunosuppressant Portfolio Growth: 12% growth in H1 FY26.
API Business Contribution: 9% of total business, with recovery efforts following a fire incident.
Sales Force Productivity: INR 6.5 lakhs per rep per month, up from INR 6.1 lakhs last year.
Specialty Productivity: INR 17 lakh PCPM in Q2.
Release Date: October 17, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
RPG Life Sciences Ltd (BOM:532983) reported a robust growth of 17.2% in its domestic formulation business for Q2 FY26, significantly outpacing the Indian pharmaceutical market growth of 7.7%.
The company advanced its IPM ranking by 6 places, moving from 62 to 56, driven by volume expansion, strategic brand building, and disciplined execution.
RPG Life Sciences Ltd’s largest brand, Naprosyn, grew 16% year-over-year in H1 FY26 and is on track to become the company’s first INR100 crore brand.
The company remains debt-free with a high cash surplus of approximately INR223 crores, despite significant CapEx investments in modernizing and enhancing its plants.
RPG Life Sciences Ltd was recognized as the leading mid-corporate of India 2025 by Dun & Bradstreet, reflecting its strong operational and quality focus.
The company faced headwinds in its API business due to a fire incident at its factory in January, leading to a sales loss of INR16 crores.
Gross margin compression was noted, partially due to reliance on third-party suppliers and the inability to produce captive API following the fire incident.
RPG Life Sciences Ltd does not currently have any exposure to the U.S. market, which could limit its growth opportunities in one of the largest pharmaceutical markets.
There is ongoing margin pressure in the MABs (monoclonal antibodies) segment due to increased competition and price erosion.
Despite the company’s strong domestic performance, the international formulation business only grew by 7.0% in Q2, indicating slower growth compared to the domestic market.
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(END) Dow Jones Newswires
October 20, 2025 00:15 ET (04:15 GMT)
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