On July 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter of fiscal year 2025 (Press release, Chugai, JUL 24, 2025, View Source [SID1234654499]).

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Chugai reported increased revenue and operating profit year-on-year for the second quarter (Core-basis).

Regarding revenue, domestic sales increased by 2.8%. In the oncology field, sales decreased by 1.9%. While new products Phesgo performed well and Lunsumio steadily penetrated the market, this was offset by the decline in Perjeta and Herceptin along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. In the specialty field, sales increased by 8.4%, driven by significant growth of the mainstay product Vabysmo and successful market penetration of the new product PiaSky. Overseas sales increased by 7.3%, driven by a substantial increase in exports of Actemra to Roche. Other revenue decreased by 0.4%, despite the increase in royalty income related to Hemlibra, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 1.3 percentage points year-on-year to 34.3%, mainly due to changes in the product mix. Research and development expenses increased by 2.7% due to investments into drug discovery and early development, and increase associated with the progress of development projects, while selling, general and administrative expenses decreased by 2.6% due to efficient management of various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥272.0 billion (+3.5%).

Chugai made good progress in both early and late-stage development activities.

In early-stage development of in-house projects that will drive mid to long-term growth, GYM329 (for obesity) and Hemlibra (for von Willebrand disease) have initiated Phase II and Phase III clinical trials, respectively. Additionally, AUBE00 (for solid tumors), the second clinical-stage project following LUNA18 in our mid-size molecule pipeline, has initiated Phase I clinical trials. In late-stage development, Alecensa has been filed for approval for additional tumor agnostic indication in ALK fusion / rearrangement gene-positive solid tumors, including pediatric patients. In-house projects out-licensed to third parties excluding Roche also progressed steadily, with AVMAPKI, out-licensed to Verastem Oncology, receiving approval from the U.S. Food and Drug Administration (FDA) for use in combination with FAKZYNJA for KRAS-mutated recurrent low-grade serous ovarian cancer, under the accelerated approval pathway* based on overall response rate and duration of response.

Chugai has made the management decision to discontinue our development of five projects from early-stage in-house clinical development pipeline; LUNA18, SAIL66, SOF10, STA551, and AMY109. Since the launch of TOP I 2030 in 2021, we have continuously generated new projects and built technological foundations through enhanced RED functions. The number of early-stage projects has been increasing, with nine in-house projects entering clinical development over the four-year period. For early-stage clinical development pipeline, we have prioritized in-house projects after considering obtained data and the current portfolio situation, resulting in the decision to discontinue these five projects. Through this decision, we aim to maximize the success rate of achieving TOP I 2030 goals through dynamic and strategic allocation of resources to priority projects.

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, Elevidys has obtained regulatory approval as a regenerative medicine product for the treatment of Duchenne muscular dystrophy under the conditional and time-limited approval pathway in Japan. Vabysmo has received approval for an additional indication for angioid streaks, and Evrysdi has launched a new formulation in Japan. Lunsumio has been filed for an additional indication in combination with Polivy for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and Tecentriq has been filed for an additional indication for unresectable thymic cancer. Additionally, Vabysmo (for non-proliferative diabetic retinopathy) and inavolisib (for PIK3CA mutated breast cancer) have initiated new clinical trials.

[2025 second quarter results]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Core results
Revenue 578.5 552.9 +4.6%
　Sales 511.4 485.5 +5.3%
　Other revenue 67.0 67.3 -0.4%
Operating profit 272.0 262.8 +3.5%
Net income 193.5 189.5 +2.1%
IFRS results
Revenue 578.5 552.9 +4.6%
Operating profit 273.3 258.2 +5.8%
Net income 194.4 186.3 +4.3%
[Sales breakdown]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Sales 511.4 485.5 +5.3%
Domestic sales 223.3 217.2 +2.8%
　Oncology 116.6 118.8 -1.9%
　Specialty 106.7 98.4 +8.4%
Overseas sales 288.1 268.4 +7.3%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Tecentriq 29.9 31.1 -3.9%
Polivy 17.0 15.7 +8.3%
Alecensa 15.8 14.9 +6.0%
Phesgo 15.4 8.6 +79.1%
Avastin 13.0 17.4 -25.3%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Jun 2024
Jan – Jun % change
Hemlibra 29.1 27.4 +6.2%
Actemra 23.8 22.4 +6.3%
Enspryng 13.3 11.6 +14.7%
Vabysmo 12.0 9.1 +31.9%
Evrysdi 7.9 7.5 +5.3%
[Progress in R&D activities from Apr 25th, 2025 to Jul 24th, 2025]

2025 Q2 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On July 23, 2025 Boston Scientific Corporation reported the company generated net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234656859]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.

On July 23, 2025 Boston Scientific reported second quarter 2025 financial results (Presentation, Boston Scientific, JUL 23, 2025, View Source [SID1234656858]).

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On July 23, 2025 Lithea Pharma reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead investigational therapy, LIT1001, intended for the treatment of osteosarcoma (Press release, Lithea Pharma, JUL 23, 2025, View Source [SID1234656338]).

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This designation marks a key regulatory milestone and reinforces the potential of LIT1001 to address a critical unmet medical need in oncology. The ODD status provides significant development incentives, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, waived FDA fees, and protocol assistance from the FDA.

"We are proud that the FDA acknowledges the potential of LIT1001 to outperform current standard-of-care treatments," said Ludvig Sjöberg, CEO of Lithea. "Our preclinical data demonstrate that LIT1001’s targeted delivery of doxorubicin significantly improves tumor control while reducing systemic toxicity – a promising advancement for young patients with osteosarcoma."

LIT1001: An innovative localized chemotherapy approach
LIT1001 is a next-generation chemotherapeutic formulation designed to deliver doxorubicin directly into the tumor environment, bypassing systemic exposure and enhancing local efficacy. Built on Lithea’s proprietary bone mineral platform – a biocompatible matrix of hydroxyapatite and calcium sulfate – LIT1001 enables sustained, controlled release of doxorubicin at the tumor site, with the goal of minimizing toxic side effects while maximizing therapeutic impact.

"Osteosarcoma is highly aggressive and unforgiving. In preclinical studies, LIT1001 has shown the ability to suppress local tumor growth while preserving healthy tissue," said Dr. Mathias Lidgren, Chief Medical Officer at Lithea. "By delivering chemotherapy directly to the tumor, we are pioneering a new paradigm for localized cancer treatment."

Osteosarcoma – a life-threatening diagnosis with no new treatments in over 40 years
Osteosarcoma is the most common primary bone cancer in children and young adults. Despite aggressive multimodal treatment, including surgery and systemic chemotherapy, survival rates have remained stagnant for decades. While localized disease has a 5-year survival rate of around 60–70%, metastatic or recurrent osteosarcoma has a 5-year survival rate below 30%. Critically, no new drugs have been approved for this indication in over 40 years.

A platform for future oncology therapies
Lithea’s proprietary platform is based on over 40 years of academic research, initially developed at Lund University and now validated across multiple preclinical oncology models. The underlying bone mineral matrix can be loaded with various anticancer agents and is designed to address a broad range of solid tumor indications. In addition, its unique ability to be "recharged" by systemically administered drugs offers further treatment flexibility and opens the door to combination therapies.

Multiple pipeline programs based on this platform are in development, targeting other hard-to-treat solid tumors with tailored, localized drug delivery.

On July 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel immuno-oncology payload antibody drug conjugates (ADCs) for the treatment of cancer, reported its commitment to ongoing research to better understand the multiple effects of its novel spliceosome modulator, PH1, having demonstrated it may also act to inhibit key drivers in cancer tumors (Press release, Akari Therapeutics, JUL 23, 2025, View Source [SID1234654668]).

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"We are excited to build on the scientific data already established for our novel PH1 spliceosome modulator payload with continued, ongoing research," commented Abizer Gaslightwala, President and CEO of Akari Therapeutics. "In addition to the cytotoxic and immuno-oncology modes of action for this payload, we have also demonstrated its ability to induce cytotoxicity in cancer cells under the influence of key oncogenic drivers such as KRAS, BRAF, and FGFR3 (Patent WO2024220546A2). As such, we are continuing to further investigate how this novel payload may impact other key drivers relevant to cancer tumors, and we look forward to releasing this key data in the near future."

Akari’s ADCs utilize its novel spliceosome modulator payload, PH1, and have the potential to significantly improve future oncology therapies based on current preclinical data demonstrating the following:

• Killing cancer cells while activating the immune system: In addition to killing cancer cells, spliceosome modulation by the PH1 payload causes the accumulation of mis-spliced proteins, generating neoantigens that activate the immune system to further attack the cancer tumor.

• Reducing off-target toxicity: Linker is engineered to only release PH1 payload intracellularly within targeted cancer cells to mitigate off-target toxicity.

• Circumventing traditional cancer resistance mechanisms: PH1 is resistant to standard efflux transporters that can cause cancer cells to become resistant to current payloads used on ADCs.

Akari continues to build on this key data for its spliceosome modulator payload with further research ongoing on how the payload can also disrupt key drivers responsible for cancer cell growth. Preliminary data from additional preclinical research experiments testing activity of PH1 against an established oncogenic driver unique to a major tumor are expected before year-end.