On August 28, 2025 Novotech, a globally recognized full-service clinical research organization (CRO), reported to have partnered with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Pharma) in achieving a significant regulatory milestone: the approval of Anlotinib Hydrochloride Capsules for a new indication as a first-line treatment for unresectable locally advanced or metastatic soft tissue sarcoma (STS) in combination with chemotherapy (Press release, Jiangsu Chia-tai Tianqing, AUG 28, 2025, View Source [SID1234655569]). This approval marks the ninth indication for Anlotinib in China and represents the world’s first official approval of an Anlotinib-chemotherapy combination for first-line treatment of advanced or metastatic STS.

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Previously recommended as a second-line monotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines, Anlotinib was the only Grade I targeted therapy for STS. This new indication represents a significant advancement for patients who have not previously received systemic treatment, expanding access to more effective and targeted first-line therapeutic options.

Novotech provided a comprehensive suite of regulatory-compliant biostatistics services in support of the development program, including protocol review and design, statistical analysis plans, CDISC datasets generation, and post-database lock outputs of TFL (Tables, Figures, and Listings). These contributions enhanced data transparency, improved result interpretability, and played a critical role in the successful NDA submission.

The Phase III study demonstrated compelling results:

Anlotinib combination therapy improved median progression-free survival by 5.6 months.
Delivered an objective response rate of 17.8% compared to 2.9% in the control group.
The disease control rate climbed to 79.3%, underscoring the clinical potential of the new regimen.
Novotech’s expert biostatisticians and programmers provide end-to-end services, from protocol design and statistical consultation to comprehensive reporting, supporting clinical programs from first-in-human through Phase IV.

Our collaboration with CTTQ Pharma reflects a shared commitment to advancing outcomes for patients facing difficult-to-treat cancers. The expanded use of Anlotinib in combination with chemotherapy opens new possibilities for advancing care in soft tissue sarcoma and highlights the role Novotech’s partnership model plays in shaping the future of oncology research.

On August 28, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025, at 9:45 a.m. ET in NYC (Press release, Nuvalent, AUG 28, 2025, View Source [SID1234655568]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On August 28, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported that Dr. Steven Quay, Chairman and Chief Executive Officer, will participate in a fireside chat with biotech research analyst, Emily Bodnar, at the H.C. Wainwright (HCW) 27th Annual Global Investment Conference on Monday, September 8, 2025, at 3:00 p.m. ET, at the Lotte New York Palace Hotel in New York City (Press release, Atossa Therapeutics, AUG 28, 2025, https://www.prnewswire.com/news-releases/atossa-therapeutics-ceo-to-discuss-clinical-progress-and-upcoming-milestones-at-27th-annual-hc-wainwright-global-investment-conference-302540635.html [SID1234655567]).

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Dr. Quay will provide an update on Atossa’s lead program, (Z)-endoxifen, a highly potent Selective Estrogen Receptor Modulator (SERM) with dual mechanisms of action that may offer a differentiated solution for women in both prevention and treatment settings of breast cancer. This includes progress across multiple clinical studies and encouraging feedback recently received by regulatory advisors that could accelerate the Company’s path forward.

The live presentation will be webcast, with a replay available for approximately 90 days on the Company’s investor website: View Source

In addition, a 60-second video message from Dr. Quay previewing the presentation is now available here, offering a personal invitation to learn more of Atossa’s vision and upcoming catalysts.

Investors interested in scheduling meetings with Atossa management may do so through the HCW conference portal, via their HCW representative, or directly by contacting a Company representative.

On August 28, 2025 Foresee Pharmaceuticals (6576.TWO), ("Foresee") reported that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer (Press release, Foresee Pharmaceuticals, AUG 28, 2025, View Source [SID1234655565]).

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"The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder, Chairman, and CEO of Foresee. "It is also a key step in our efforts to build Foresee as a profitable and growing business. We want to thank the team and all stakeholders for their tireless work, which has made this approval possible.

The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

As it was the case for CAMCEVI 42 mg, we anticipate the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by our partner will seek to find a balance between near term uptake and the optimization of mid/long term growth.

CAMCEVI ETM is exclusively licensed to Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. for commercialization in the U.S.

On August 28, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that management will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Compugen, AUG 28, 2025, https://www.prnewswire.com/news-releases/compugen-to-present-at-the-hc-wainwright-27th-annual-global-investment-conference-302540915.html [SID1234655564]).

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The fireside chat will be available on demand on the Investor Relations section of Compugen’s website at www.cgen.com from Friday, September 5, 2025, 7:00 AM ET for 90 days.