On August 26, 2026 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SOT106, the company’s potentially best-in-class investigational antibody-drug conjugate (ADC), for the treatment of soft tissue sarcoma, underscoring the urgency of developing new treatment options and the potential of SOT106 to address a significant unmet medical need.

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SOT106 targets leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across multiple highly prevalent sarcoma subtypes, positioning it to potentially address a broad population of patients with limited therapeutic options.

"Soft tissue sarcomas (STS) remain a major unmet medical need, where decades of therapeutic progress have yet to translate into meaningful improvements for patients with advanced or recurrent disease," said Vivi Boura, M.D., chief medical officer of SOTIO. "Receiving Fast Track Designation for SOT106 is an important regulatory milestone that reinforces this program’s potential to improve outcomes for patients facing these difficult-to-treat cancers. As we advance SOT106 toward the clinic, we aim to translate its differentiated design and LRRC15-targeting strategy into a novel therapeutic approach with the potential to offer a new treatment option for patients across multiple soft tissue sarcoma subtypes."

Fast Track Designation is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs. The designation provides opportunities for more frequent interactions with the FDA and may support an accelerated pathway through eligibility for rolling review and Priority Review, if applicable criteria are met.

SOT106 has also received FDA Orphan Drug Designation for the treatment of osteosarcoma, further highlighting its potential across high-need sarcoma indications. SOTIO expects to initiate a first-in-human clinical trial later this year, marking the next key milestone in clinical development of SOT106.

(Press release, SOTIO, AUG 26, 2026, View Source [SID1234670375])

On August 26, 2026 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported its 2026 interim financial results and provided corporate updates.

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FINANCIAL HIGHLIGHTS

As of June 30, 2026, the company’s total revenue was approximately RMB1,696 million for the first half of 2026 (2026H1), a 45% increase compared to 2025, which was made possible by the rise in sales revenue of pharmaceutical products. In particular, the domestic sales revenue of our core product, toripalimab, reached approximately RMB1,299 million, around 36% more than in 2025. In addition, out-licensing revenue also increased by approximately RMB152 million, an approximately 149% improvement from 2025.
Total research and development ("R&D") expenses of the company were approximately RMB644 million for 2026H1, which was primarily used to advance the construction of our R&D technology platforms, explore potential drug targets and strengthen our clinical pipelines.
Profit attributable to owners of the company increased to RMB26 million for 2026H1, representing an increase of approximately RMB439 million compared to 2025. When excluding the effects of share-based payment, profit attributable to owners of the company reached RMB153 million, representing an increase of approximately RMB566 million compared to 2025.
Net cash inflow from financing activities was approximately RMB1,643 million, which fully covered the cash outflows in operating and investing activities, leading to an increase in bank balances and cash. A successful issuance of the 2026 first tranche of technology innovation bonds generated a net cash inflow of approximately RMB1,000 million for the company.
As of June 30, 2026, the company’s aggregate of bank balances, cash, and financial products reached approximately RMB3,670 million, providing a relatively sufficient cash position for further development.
BUSINESS HIGHLIGHTS

During 2026H1, we remained steadfast in tackling patients’ "unmet medical needs" and realizing our goal of "improving quality, reducing cost and enhancing efficiency." We continued to ensure all-rounded, high-quality compliance, and made breakthrough progress in discovery, clinical development and commercialization of innovative drugs and business operations with accelerating international development.

Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, antibody drug conjugates ("ADC"), bi-specific or multi-specific antibodies, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies including those for cancer and autoimmune diseases. To date, a total of four drugs (TUOYI, JUNMAIKANG, MINDEWEI and JUNSHIDA) have been commercialized, five products are in phase 3 clinical studies (including two products currently awaiting new drug application [the "NDA"] acceptance), and various innovative drugs that are competitive in the international market are undergoing accelerated clinical trials.

In February 2026, the indications of toripalimab for the first-line treatment of nasopharyngeal carcinoma ("NPC") and the first-line treatment of esophageal squamous cell carcinoma ("ESCC") were approved for marketing in Oman and Qatar.
In March 2026, the NDA for JS001sc (toripalimab injection [subcutaneous injection]) for 12 indications in the treatment of tumors were accepted by the National Medical Products Administration (the "NMPA").
In April 2026, the indication expansion of toripalimab for the first-line treatment of ESCC was approved for marketing in Singapore.
In May 2026, the supplemental new drug application ("sNDA") for the new indication of TUOYI in combination with disitamab vedotin for the treatment for patients with human epidermal growth factor receptor 2 ("HER2")-expressing (which is defined as achieving score of 1+, 2+ or 3+ in HER2 immunohistochemistry test) locally advanced or metastatic urothelial carcinoma ("UC") was approved by the NMPA.
In May 2026, the phase 3 clinical study of TUOYI in combination with chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer ("NSCLC") patients met the primary endpoint in the final analysis. In July 2026, the supplemental application for the indication of TUOYI in combination with chemotherapy as perioperative treatment for resectable stage II-III NSCLC patients was accepted.
In May 2026, the indications of toripalimab for the first-line and second-line or later treatment of NPC were approved for marketing in Malaysia and South Africa.
In June 2026, the indications of toripalimab for the first-line treatment of NPC and first-line treatment of ESCC were approved for marketing in Peru.
In June 2026, the indications of toripalimab for the first-line and second-line or later treatment of NPC were approved for marketing in Brazil.
Updates on external collaborations

In June 2026, JunTop Biosciences, a controlling subsidiary of the company, reached a collaborative agreement with the Institute of Microbiology, Chinese Academy of Sciences. JunTop Biosciences was granted the exclusive global license rights for quadrivalent recombinant dengue vaccine.
In June 2026, the company entered into a license agreement with Fosun Wanbang, a wholly-owned subsidiary of Fosun Pharma. The company granted Fosun Wanbang the right to develop, register, manufacture and commercialize roconkibart ("JS005" or "anti-IL-17A monoclonal antibody") in the Greater China region. Under the agreement, the company will receive an upfront payment of RMB215 million, which shall be non-deductible and non-refundable, and will be eligible to receive milestone payments for product development and sales of RMB1,125 million, as well as double-digit tiered royalties based on net sales in the Greater China region.
Updates on other significant events

From November 2025 to March 2026, Mr. Xiong Jun, one of the controlling shareholders and actual controllers, and the chairman of the Board of the Directors of Junshi Biosciences, increased his shareholding of the company by 3,259,495 A shares and H shares in aggregate, accounting for 0.32% of the total share capital of the company, with a total transaction amount of RMB100,638,052.19.

(Press release, Shanghai Junshi Bioscience, AUG 26, 2026, View Source [SID1234670373])

On August 26, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing tumors. This follows a positive recommendation from the Safety and Monitoring Committee (SMC), an independent multidisciplinary committee, to advance to the 70 mCi dose of RV-01.

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RV-01 is a 177Lutetium-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

The Phase 1/2a clinical trial is a dose escalation and expansion trial designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity of RV-01 in B7-H3 expressing tumors. The trial will determine the recommended dose of RV-01 to move forward in future studies. The Phase 1/2a study is currently being conducted at clinical centers across the U.S.

"Dosing the first patient in the second dose cohort of our Phase 1/2a RV-01 study marks an important clinical and operational milestone for Radiopharm and reflects the continued advancement of this first therapeutic radiopharmaceutical program from our joint venture with MD Anderson Cancer Center," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The recommendation to proceed to the 70 mCi dose level provides an important early indication of the program’s progression through dose escalation and reinforces our confidence in RV-01’s development pathway."

"B7-H3 remains one of the most compelling targets in oncology due to its broad expression across multiple solid tumor types, and we believe RV-01 has the potential to emerge as a differentiated therapeutic approach for patients with significant unmet needs. We remain focused on enrolling patients in the current cohort and look forward to reporting initial clinical data later this year," commented Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.

About RV-01

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

About the Phase 1/2a Clinical Trial
The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-Betabart (RV-01). The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.

(Press release, Radiopharm Theranostics, AUG 26, 2026, View Source [SID1234670372])

On August 26, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported that Roger M. Perlmutter, M.D., Ph.D., Chairman and Chief Executive Officer, and Freddie Bowie, Ph.D., Chief Financial Officer, will participate in two upcoming investor conferences taking place in September:

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Event:12th Annual Cantor Global Healthcare Conference
Location: New York, NY
Date & Time: September 10, 2026 at 2:10 pm ET
Format: Fireside Chat

Event: The Morgan Stanley 24th Annual Global Healthcare Conference
Location: New York, NY
Date & Time: September 15, 2026 at 4:05 pm ET
Format: Fireside Chat

Live audio/video webcasts of these presentations will be accessible through Eikon’s investor relations website at www.investors.eikontx.com, with an archived edition of the session available later that day and accessible for approximately 30 days after the live event.

(Press release, Eikon Therapeutics, AUG 26, 2026, View Source [SID1234670371])

On August 26, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported comments following the recent FDA approval of a new second-line pancreatic cancer treatment.

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"Approval of this new treatment is good news for the subset of pancreatic cancer patients who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy," said Ben Zeskind, Ph.D., CEO of Immuneering. "The top priority for the pancreatic cancer field now turns to the development of treatments for first-line metastatic pancreatic cancer patients. Immuneering is focused on treating these patients, and our Phase 3 MAPKeeper 301 study is enrolling them now. Atebimetinib is designed to help cancer patients live longer through a balance of attacking tumors and protecting patients. From the beginning, we have sought to control disease in parallel with maintaining body weight and minimizing harsh side effects such as rash, diarrhea, stomatitis, and fatigue. Our goal is to give first-line pancreatic cancer patients a choice that can help them live long, stay strong, and feel well."

MAPKeeper 301 (NCT07562152) is a global, randomized pivotal trial evaluating atebimetinib in combination with chemotherapy in patients with first-line metastatic pancreatic cancer. More than 35 trial locations are already listed on ClinicalTrials.gov.

As previously reported, Immuneering’s open-label, single-arm Phase 2a trial achieved 17.3 months median overall survival in 55 first-line metastatic pancreatic cancer patients treated with atebimetinib 320 mg once daily plus modified gemcitabine/nab-paclitaxel (mGnP), as of the April 24, 2026 data cutoff, with median follow-up of 11.6 months. Notably, 84% of evaluable patients maintained or gained weight at three months. The only treatment-related adverse events observed at Grade 3 or higher in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related.

(Press release, Immuneering, AUG 26, 2026, View Source [SID1234670370])