Shanghai Ark Biopharmaceutical Co., Ltd announced today that China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for AK0406 injection, the company’s first antiviral drug-Fc conjugate (AFC) candidate designed for long-acting influenza prevention. The approval makes AK0406 the first influenza-focused AFC candidate in China to progress into clinical development.

AK0406 is a next-generation, long-acting antiviral candidate discovered and developed by ArkBio. The molecule combines a highly potent antiviral small-molecule agent with an antibody Fc fragment through targeted conjugation, with the aim of delivering sustained protection before and after exposure and potentially offering therapeutic benefits.

This approach is intended to address the continuing need for effective influenza prevention, particularly during periods of high seasonal transmission. Preclinical studies indicate that AK0406 has potent and broad activity against both influenza A and influenza B viruses, while retaining immune effector activity and achieving prolonged systemic exposure. Its molecular design is intended to provide a balanced profile suitable for both influenza prophylaxis and treatment.

ArkBio is also advancing AK0406 through international clinical development. In February 2026, the company received authorization from an Australian Human Research Ethics Committee (HREC) to begin a Phase I study. Recruitment and dosing of healthy adult participants across all planned cohorts in Australia have been completed, and the study has subsequently moved into the follow-up stage.

Influenza continues to represent a substantial global public health burden. Existing prevention strategies rely heavily on seasonal vaccination, but these approaches have inherent challenges. These include the difficulty of accurately anticipating and matching circulating viral strains each year, the effects of ongoing antigenic drift, and lower levels of vaccine protection in certain vulnerable groups, including older adults and people with compromised immune systems. Consequently, significant unmet needs remain in influenza prevention.

ArkBio plans to work closely with China’s Center for Drug Evaluation (CDE) to support the continued clinical development of AK0406 in China while completing follow-up activities associated with the Phase I study in Australia. Through a coordinated development strategy spanning China and international markets, the company intends to advance the program efficiently and ultimately develop a safe, effective, and convenient option for influenza prevention worldwide.

Mabwell (688062.SH), an innovation-focused biopharmaceutical company with an integrated value chain, has announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its novel LILRB4/CD3 T cell engager (TCE) bispecific antibody, 6MW5311. This candidate is being developed to treat hematologic cancers, including Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM).

6MW5311 is the first LILRB4/CD3 TCE bispecific antibody worldwide to reach the clinical trial application stage, highlighting its strong development potential and promising commercial outlook. In the United States, the IND process is currently at the pre-IND stage, with a formal submission to the FDA planned for the second quarter of 2026.

Built on a T cell engager platform, 6MW5311 features a “2+1” asymmetric design that enables it to bind simultaneously to LILRB4 on tumor cells and CD3 on T cells. This dual targeting facilitates the formation of an immune synapse, activating T cells to effectively attack cancer cells.

The molecule also incorporates a distinctive steric hindrance mechanism that limits CD3 binding in the absence of tumor cells. As a result, T cells are primarily activated only when tumor cells are present, which enhances safety while maintaining strong anti-tumor activity.

Preclinical in vitro studies have shown that 6MW5311 demonstrates robust cytotoxic effects across various tumor cell lines and patient-derived samples. In vivo studies further indicate significant tumor suppression in both high and low LILRB4-expressing AML models, with complete tumor elimination observed in high-expression cases. Additionally, safety evaluations in cynomolgus monkeys suggest a favorable safety profile.

T cell engager therapies represent an important strategy for directing immune cells to target cancer, and they have already shown meaningful clinical success in several lymphoma indications, with multiple approved products. However, treatment options for AML and CMML are still largely limited to chemotherapy, stem cell transplantation, and mutation-specific targeted therapies. To date, no TCE therapies have been approved for these diseases.