On April 15, 2026 Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain, reported that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

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MAIWEIJIAN is the first denosumab biosimilar (120mg) approved to market in China. It was initially approved in March 2024 for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In August 2025, the product received approval from the Drug Regulatory Authority of Pakistan as the country’s first denosumab biosimilar (120mg), and supply has now commenced. Mabwell has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications in 8 countries.

Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. As the first denosumab biosimilar (120mg) launched in China, MAIWEIJIAN possesses early-mover advantages. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages:

Targeted action – It specifically binds to RANKL, blocking the RANKL/RANK/OPG signaling pathway, thereby preventing and treating SREs caused by bone metastases.
Superior clinical efficacy – It demonstrates significantly better clinical efficacy than bisphosphonates and remains effective in patients who have failed bisphosphonate therapy.
Favorable safety profile – It is not cleared by the kidneys, and patients receiving denosumab experience fewer renal toxicity side effects.
Previously, Mabwell published the Phase I and Phase III clinical study results of this product in International Immunopharmacology and the top-tier international journal JAMA Oncology, respectively. Through head-to-head pharmacokinetic comparisons and clinical efficacy studies in patients with bone metastases from solid tumors, the product has been systematically and comprehensively demonstrated to be similar to the reference product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety.

(Press release, Mabwell Biotech, APR 15, 2026, View Source [SID1234664407])

On April 15, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its innovative LILRB4/CD3 TCE bispecific antibody (R&D code: 6MW5311). The drug candidate is being developed for hematologic malignancies, specifically Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM).

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6MW5311 is the world’s first innovative LILRB4/CD3 TCE bispecific antibody for which a clinical trial application has been submitted. It possesses broad prospects for clinical development and significant market potential. The U.S. IND application is currently in the pre-IND phase, with plans to formally submit it to the FDA in the second quarter of 2026.

6MW5311 is developed based on the T Cell Engager (TCE) technology platform and features a "2+1" asymmetric molecular structure. It simultaneously targets LILRB4 and CD3, forming an immunological synapse by bridging tumor cells and T cells, thereby activating T cells to efficiently kill tumors.

The molecule incorporates a unique steric hindrance design. This structure significantly reduces the binding activity of the CD3 antibody to T cells in the absence of tumor cells. T cells are specifically activated only when tumor cells are present, which substantially enhances safety while improving anti-tumor efficacy.

In vitro studies have demonstrated that 6MW5311 exhibits potent cytotoxic activity across multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic studies have shown that 6MW5311 achieves significant tumor inhibition in both LILRB4-high and LILRB4-low expressing AML tumor models. Notably, it achieved complete tumor clearance in high-expression models. Furthermore, 6MW5311 demonstrated a favorable safety profile in cynomolgus monkey safety evaluation models.

As a key technological approach for directly mobilizing T cells to kill tumors, TCE has shown significant clinical value in various lymphoma indications, with multiple products successfully launched. However, current treatments for AML and CMML primarily remain primarily limited to chemotherapy, hematopoietic stem cell transplantation, and targeted therapies for specific mutations; no TCE products have been approved for these indications to date.

About Acute Myeloid Leukemia (AML)
AML is a group of clonal malignant disorders originating from myeloid stem cells, characterized by high heterogeneity and mortality. Globally, approximately 172.4 thousand new cases of AML were diagnosed in 2022, with the number projected to reach 221.4 thousand by 2035, representing a compound annual growth rate (CAGR) of 1.94%. In China, approximately 30.8 thousand new AML cases were diagnosed in 2022, accounting for approximately 17.9% of the global total. The number is expected to reach 36.7 thousand by 2035, representing approximately 16.6% of the global total, with a CAGR of 1.36%.

About Chronic Myelomonocytic Leukemia (CMML)
CMML is a clonal hematopoietic stem cell disorder that shares overlapping features with both myelodysplastic syndrome (MDS) and Myeloproliferative Neoplasm (MPN). It is characterized by significant monocytosis in peripheral blood and carries an inherent risk of transformation to AML (approximately 15-20% within 3-5 years). CMML is a rare disease with an annual incidence of approximately 3-4 per 100,000, and currently lacks effective treatment options.

About Multiple Myeloma (MM)
MM is a clonal plasma cell malignancy characterized by the uncontrolled proliferation of monoclonal plasma cells in the bone marrow. This leads to the overproduction of abnormal immunoglobulins and subsequent end-organ damage, manifested as hypercalcemia, renal impairment, anemia, and bone lesions (collectively known as CRAB features). Globally, MM accounts for approximately 1%-2% of all cancers and about 10% of hematologic malignancies. The median age at diagnosis is approximately 69 years, with higher incidence rates observed in males and individuals of African descent. Over the past two decades, patient survival rates have significantly improved thanks to the application of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. However, MM remains largely incurable, and most patients experience multiple relapses during the course of the disease.

(Press release, Mabwell Biotech, APR 15, 2026, View Source;nmpa-accepts-ind-application-for-mabwells-innovative-lilrb4cd3-tce-bispecific-antibody-6mw5311-302744036.html [SID1234664406])

On April 15, 2026 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Executive Officer, is scheduled to present a corporate update at the 2026 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 21, 2026, at 2:00 p.m. ET at the Metro Toronto Convention Centre (North Building) in Toronto. A copy of the presentation will be available at www.knighttx.com.

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(Press release, Knight Therapeutics, APR 15, 2026, View Source;Co–Healthcare-Investor-Conference/default.aspx [SID1234664405])

On April 15, 2026 Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, reported the closing of a $108 million Series C financing round. The round includes new investors RA Capital Management, Deep Track Capital, Osage University Partners (OUP), and BeOne Medicines, and participation from existing investors OrbiMed, Third Rock Ventures, Novo Holdings, and Cormorant Asset Management.

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"Proceeds from this financing enable us to advance our lead AKT1-selective inhibitor programs through Phase 1 clinical development for patients with cancer and rare diseases such as hereditary hemorrhagic telangiectasia," said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto. "We are grateful for the support from new and existing investors as we work to unlock the full potential of selective AKT1 inhibition and bring more effective and better tolerated treatment options to patients with significant unmet need."

Terremoto’s lead oncology program, TER-2013, is currently in Phase 1 clinical development for solid tumors harboring genetic alterations in PIK3CA, AKT, or PTEN, which are implicated in a significant proportion of cancers, including more than half of patients with HR-positive breast cancer. The company is also advancing TER-4480, a program targeting hereditary hemorrhagic telangiectasia (HHT), a rare, inherited bleeding disorder characterized by abnormal blood vessel formation and significant morbidity, with currently no approved therapies. TER-4480 is expected to enter the clinic later this year.

AKT is a key regulatory protein implicated in driving disease progression in both cancer and HHT. Among the three structurally similar isoforms (AKT1, AKT2, AKT3), AKT1 has been shown in preclinical studies to be the predominant disease driver, while AKT2 is linked to adverse effects such as rash and dysregulation of glucose homeostasis. While there has been considerable advancement of other PI3K/AKT pathway inhibitors, the efficacy of these treatments has often been limited by toxicities – primarily due to PI3Kα or AKT2 inhibition. Using advanced medicinal chemistry capabilities, Terremoto has developed a novel class of AKT1-selective inhibitors to overcome these limitations, aiming to achieve deeper and more durable treatment response with an improved tolerability profile.

(Press release, Terremoto Biosciences, APR 15, 2026, View Source [SID1234664404])

On April 15, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the publication of clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating its tumor-targeted IL-12 immunocytokine, PDS01ADC, in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances.

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The clinical trial, led by Dr. Jonathan Hernandez, MD, Investigator in the Surgical Oncology Program at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), combined subcutaneous injection of PDS01ADC with floxuridine (FUDR), delivered via hepatic artery infusion pump (HAIP), in patients with MSS or pMMR metastatic colorectal cancer with liver metastases who had failed at least one round of prior treatment (NCT05286814). Immune checkpoint inhibitors have been ineffective to date in about 95% of mCRC patients with MSS or pMMR disease1. Patients interested in enrolling in this study may contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or visit the web site: View Source and/or email NCIMO [email protected].

The open-label, single-center, non-randomized Phase 2 trial utilizes a Simon two-stage design and includes three disease cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. The publication reports data from the metastatic colorectal cancer cohort of the trial.

Key findings from Stage 1 (N=9) of the 22-patient study*

In colorectal cancer patients with liver metastases previously treated with at least one line of chemotherapy, who had failed prior treatment, the addition of PDS01ADC to HAIP therapy appears to enhance the immune response and clinical responses.:

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Objective response rate by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)

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24-month survival rate: Approximately 85%; in the parallel study without PDS01ADC, the 2-year survival rate was approximately 40%

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Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months

*No head-to-head trials have been performed.

"HAIP was approved by the FDA in 2024 and is gaining prominence at leading oncology centers. Despite many meaningful advances in oncology, metastatic colorectal cancer remains an area of significant unmet need. These early results showing strong tumor response rates and promising patient survival are encouraging and support our approach of subcutaneously administering PDS01ADC to activate the immune system against the cancer," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe these findings represent a meaningful step toward more precise immune-based treatments without the significant side effects that have historically limited traditional recombinant cytokine therapies."

The data were published in an article titled Tumor-Targeted IL-12 (PDS01ADC) With Hepatic Artery Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Nonrandomized Phase II Trial in the March 10, 2026 issue of JCO Oncology Advances (JCO Oncol Adv 3, e2500173(2026).

About PDS01ADC
PDS01ADC is a tumor-targeted immunocytokine designed to deliver Interleukin-12 (IL-12), a potent immune-activating agent, directly to the tumor while minimizing exposure to the rest of the body. The therapy uses the NHS76 antibody, which binds to DNA exposed in areas of tumor cell death, concentrating the drug where it is needed most. This targeted approach prevents the presence of free IL-12 in the body, and is designed to improve tolerability while enhancing anti-tumor potency. In clinical studies, PDS01ADC has been shown to:

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Promote the development of stem-like T cells, including memory T cells with self-renewing properties, which may support durable anti-tumor responses2

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Activate a subtype of natural killer cells associated with potent tumor-killing capability3

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Inhibit immune-suppressive cells, such as regulatory T cells and myeloid-derived suppressor cells, that can otherwise protect tumors from immune attack4

About Metastatic Colorectal Cancer
Colorectal cancer is the second leading cause of cancer-related deaths in the United States, according to the American Cancer Society. More than 150,000 new cases are diagnosed in the U.S. each year. Approximately 20% of patients have metastatic disease at the time of diagnosis, and an additional 25% of those with initially localized disease will eventually progress to metastatic cancer (Biller LH, 2021;325;(7):669-685). Globally, colorectal cancer causes nearly 2 million deaths annually, according to the World Health Organization.

(Press release, PDS Biotechnology, APR 15, 2026, View Source [SID1234664403])