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Taiho Pharmaceutical Announces the Launch of PI3Kα Inhibitor HAIZEXIN® Tablets 10mg in Japan

On July 15, 2026 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") reported that the PI3Kα inhibitor, HAIZEXIN tablets 10mg (generic name: risovalisib mesilate hydrate), has been listed on the National Health Insurance (NHI) reimbursement price list. The launch of this new product in Japan is scheduled for July 28, 2026.

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In March 2026, Haihe Biopharma K. K., a fully owned affiliate of Haihe Biopharma Co., Ltd. (hereinafter "Haihe"), obtained approval to manufacture and market HAIZEXIN in Japan for the treatment of a patient with ovarian clear cell carcinoma (hereinafter "OCCC") harboring PIK3CA gene mutations that has progressed after chemotherapy. Taiho will be responsible for sales and medical information activities for HAIZEXIN in Japan pursuant to an exclusive license agreement with Haihe, entered into in October 2025, for the development, manufacture, and commercialization of HAIZEXIN.

HAIZEXIN is a small-molecule PI3Kα inhibitor developed by Haihe. HAIZEXIN binds to the ATP-binding site of PI3Kα and inhibits its kinase activity, thereby inhibiting the phosphorylation of AKT, a downstream molecule in the PI3K signaling pathway¹, which is believed to result in antitumor effects.

Taiho and Haihe together will work with healthcare professionals to serve patients with OCCC by providing HAIZEXIN as a new treatment option.

Summary of Product Information in Japan
Brand name HAIZEXIN tablets 10mg
Generic name Risovalisib mesilate hydrate
Indications Ovarian clear cell carcinoma (OCCC) harboring PIK3CA gene mutations that has progressed after chemotherapy
Dosage and administration Normally, for adults, oral administration in fasting condition of 40mg of risovalisib once daily. Dosage should be reduced based on the patient’s condition.
Date of manufacturing and marketing approval March 23, 2026
Date listed in NHI reimbursement price listing July 15, 2026
Scheduled launch date in Japan July 28, 2026
NHI reimbursement price JPY 7,313.40 / tablet
Packaging PTP Packaging: 28 tablets (14 tablets x 2)
Manufacturer and distributor Haihe Biopharma K. K.
Distributor Taiho Pharmaceutical Co., Ltd.
About Ovarian Clear Cell Carcinoma with PIK3CA Gene Mutations
Ovarian cancer is one of the leading causes of cancer-related death in women, with approximately 320,000 new cases diagnosed worldwide in 2022, making it the third most common gynecologic cancer.2 In Japan, the number of registered ovarian cancer cases was reported to be 16,590 in 2023.3 OCCC is a histological subtype of epithelial ovarian cancer and accounts for approximately 21.9% of ovarian cancers in Japan.4 OCCC has a high prevalence of PIK3CA gene mutations, which are observed in approximately 30% to 40% of cases5,6; based on this prevalence, the annual number of patients with OCCC harboring PIK3CA gene mutations is estimated to be approximately 650 to 950. OCCC is a rare cancer with limited treatment options, and there remains a need to develop new therapies.

(Press release, Taiho, JUL 15, 2026, View Source [SID1234669206])

InnoCare Announces Publication in STTT (IF=81.2) of Phase 3 Results Showing Orelabrutinib Significantly Prolonged Progression-Free Survival in Treatment-Naïve CLL/SLL

On July 14, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported that Signal Transduction and Targeted Therapy (STTT), a Nature Portfolio journal, published a paper titled "Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial." The paper concludes that orelabrutinib significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death by 68%. Orelabrutinib achieves deeper and more durable responses, demonstrates a higher overall response rate (ORR), and exhibits an excellent safety profile, positioning it as an effective first-line treatment option for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The co-corresponding authors of the paper are Professor Jianyong Li from Jiangsu Province Hospital and Professor Lugui Qiu from the Chinese Academy of Medical Sciences, Institute of Hematology & Blood Disease Hospital. The co-first authors are Professor Fei Li from the First Affiliated Hospital of Nanchang University, Professor Keshu Zhou from Henan Cancer Hospital, and Professor Wei Xu from Jiangsu Province Hospital.

The primary endpoint was PFS as assessed by independent review committee (IRC). Secondary endpoints included overall response rate (ORR) and duration of response (DoR) assessed by both IRC and investigators, safety, etc.

Results assessed by the IRC demonstrated that orelabrutinib significantly prolongs PFS, with a hazard ratio (HR) of 0.32 (p < 0.0001). The research team observed consistent trends across all prespecified subgroups. Orelabrutinib showed superior survival benefits over the control group in patients with advanced age, Rai stage III/IV, or presented with high-risk factors such as del(11q), unmutated IGHV, or bulky disease.

The ORR in the orelabrutinib group reached 90.1%, significantly higher than the 79.2% in the control group. A post-hoc updated analysis at 30-month follow-up showed a complete response (CR) rate of 12.1% in the orelabrutinib group. The DoR in the orelabrutinib group was also significantly longer than in the control group, with an HR of 0.30.

From a safety perspective, the incidence of any-grade treatment-related adverse events (TRAEs) with orelabrutinib was comparable to that of the control group, despite a median treatment duration in the orelabrutinib group (nearly 19.3 months) being nearly four times longer than that in the control group (5.2 months).

Orelabrutinib demonstrated an excellent safety profile, with most TRAEs being Grade 1-2. The incidence of Grade≥3 TRAEs was significantly lower in the orelabrutinib group than in the control group, and no treatment-related atrial fibrillation, major bleeding, or second primary malignancies were observed.

Patients-reported quality of life (Qol) data indicated that the overall health status of the orelabrutinib group was superior to that of the control group. From cycle 16 onward, more patients had clinically meaningful improvement with orelabrutinib versus the control group, with the numerical difference increasing over time.

Orelabrutinib has been approved for the first-line treatment of CLL/SLL in China and included in the National Reimbursement Drug List in 2025, benefiting more patients.

Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia in adults. In the last few years, the advent of BTK inhibitors has revolutionized the treatment landscape of CLL/SLL, replacing highly intensive and toxic chemoimmunotherapy regimens as the standard-of-care.

Signal Transduction and Targeted Therapy (STTT) is a Nature Portfolio journal, publishing original research, reviews, and clinical advances. The SCI impact factor released in June 2026 reached 81.2.

(Press release, InnoCare Pharma, JUL 14, 2026, View Source [SID1234669224])

FDA Grants Fast Track Designation to SOTIO’s SOT109, a CDH17-targeting ADC for Colorectal Cancer

On July 14, 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 SOT109, the company’s potentially best-in-class antibody-drug conjugate (ADC), for the treatment of patients with advanced unresectable or metastatic colorectal cancer (CRC) who have exhausted standard treatment options.

SOT109 targets CDH17, a highly prevalent antigen expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies, supporting the potential for broad clinical utility and a favorable therapeutic index.

"Advanced colorectal cancer remains an area of profound unmet need, particularly for patients whose disease has progressed after standard therapies," said Vivi Boura, M.D., chief medical officer of SOTIO. "SOT109 is designed to capitalize on the unique biology of CDH17, a highly prevalent target that is broadly and consistently expressed across colorectal tumors, while having limited expression in healthy tissues. We believe Fast Track Designation underscores both the urgent need for new treatment options and the potential of SOT109 to expand the benefits of targeted ADC therapy to a substantially broader patient population."

FTD enables more frequent interactions with the FDA regarding development strategy, clinical trial design and data requirements and may provide eligibility for accelerated approval and priority review, subject to applicable criteria.

SOTIO expects to initiate a Phase 1/2 trial of SOT109 in patients with advanced unresectable or metastatic CRC in Q3 2026.

(Press release, SOTIO, JUL 14, 2026, View Source [SID1234669223])

Ernexa Therapeutics CEO Corner Highlights Differentiated ERNA-101 Platform as Company Advances Toward Planned First-in-Human Phase 1 Study in 2026

On July 14, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther discussing the significant unmet need in ovarian cancer, the Company’s differentiated approach with ERNA-101 and Ernexa’s progress toward advancing its lead cell therapy candidate into the clinic in the fourth quarter of 2026.

Ovarian cancer remains one of the deadliest cancers affecting women worldwide. While treatment options have improved over time, many patients eventually experience disease recurrence and progression, leaving limited options for women with platinum-resistant ovarian cancer. In the discussion, Mr. Luther explains how the ability of many ovarian tumors to evade immune detection represents one of the greatest scientific challenges in the disease and why ERNA-101 is designed to help overcome this barrier.

"Every ovarian cancer diagnosis impacts far more than a single patient. It affects families, loved ones and futures, which is why we believe there remains an urgent need for new therapeutic approaches," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "At Ernexa, we believe ERNA-101 has the potential to address one of the greatest scientific challenges in ovarian cancer by helping transform immunologically ‘cold’ tumors into tumors the immune system can recognize. This CEO Corner provides additional insight into the science behind our approach, the encouraging preclinical data supporting ERNA-101 and the progress we are making as we advance toward our planned first-in-human Phase 1 study in the fourth quarter of this year."

The discussion also highlights ERNA-101, Ernexa’s lead cell therapy candidate, which is designed to deliver a proprietary immune-activating cytokine directly within the tumor microenvironment with the goal of transforming immunologically "cold" tumors into tumors the immune system can recognize. Mr. Luther also discusses the Company’s proprietary off-the-shelf induced mesenchymal stem cell (iMSC) platform, which the Company believes has the potential to improve manufacturing consistency, increase scalability and ultimately make advanced cell therapies more broadly accessible to patients.

The CEO Corner also reviews encouraging preclinical findings demonstrating complete tumor clearance and 100% long-term survival in preclinical ovarian cancer models when ERNA-101 was combined with PD-1 blockade. Mr. Luther also discusses findings demonstrating remodeling of the tumor microenvironment and increased immune cell infiltration, which further support the scientific rationale behind ERNA-101. He concludes by reviewing the Company’s ongoing manufacturing, regulatory and clinical development activities as Ernexa advances toward its planned IND submission expected in Q3 2026 and anticipated first-in-human clinical study anticipated to start in Q4 2026.

The Ernexa CEO Corner is now accessible on the Company’s website and social media channels. Access it here.

(Press release, Ernexa Therapeutics, JUL 14, 2026, View Source [SID1234669222])

CancerVax Develops Novel Smart mRNA to Harness Pre-Existing Immunity in 99% of World Population

On July 14, 2026 CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that "tricks" the body’s immune system into fighting cancer, reported that it has successfully developed a single Polyepitope Smart mRNA that can disguise cancer cells as multiple viral infections.

The CancerVax platform is designed to harness the body’s existing immunity to detect, mark, and kill cancer cells with precision. At the core of the platform is a Smart mRNA that activates selectively in cancer cells. When activated, this Smart mRNA instructs cancer cells to produce proteins associated with viruses that are highly prevalent in the human population. This effectively disguises cancer cells as familiar viral infections and "tricks" the immune system into recognizing and killing them.

"Our earlier work focused on individual viral epitopes, such as measles," explained Dr. George Katibah, Chief Scientific Officer. "With our Polyepitope Smart mRNA design, we have expanded that concept by encoding multiple viral epitopes with broad population immunity, including measles, influenza, CMV and others, into a single mRNA construct. This approach is designed to increase the probability that a patient’s existing T-cell immunity will recognize at least one of these viral signals and direct an immune response against the cancer cell. Our recent in vitro results provide encouraging validation of this strategy and represent an important step toward a broadly applicable cancer immunotherapy platform."

Dr. Adam Grant, Principal Scientist, added, "Using large-scale immune epitope datasets and AI-assisted analysis, we identified and combined the most viable viral epitopes for our design to maximize the broadest population coverage. With every epitope we add, we increase the likelihood of activating existing T-cells. However, given the physical size constraints of practical mRNA design, we had to be selective. Using computational analysis, we designed a Version 1 Polyepitope Smart mRNA that provided a global population coverage of 96.26%. Since then, we’ve expanded our dataset and generated Version 2, which has a population coverage of 99.50%! This is truly a one of a kind mRNA design and we believe this broad and universal approach will be the winner we take to the clinic."

The Immune Epitope Database ("IEDB") population coverage algorithm was used to generate the following analysis of V1 and V2 Polyepitope Smart mRNA designs. IEDB, funded by the National Institute of Allergy and Infectious Diseases (NIAID), is the gold standard repository for experimentally validated immune epitope data.

(Press release, CancerVax, JUL 14, 2026, View Source [SID1234669221])