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Alligator Bioscience comments on Henlius dosing first patient in Phase 2/3 breast cancer study of HLX22

On March 2, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on the announcement by Shanghai Henlius Biotech, Inc. that the first patient has been dosed in a Phase 2/3 clinical trial of HLX22 in combination with HLX87 (an antibody-drug conjugate targeting HER2) as a first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer. The trial (NCT07294508) is conducted in Mainland China.

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HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"We are encouraged that Henlius continues to advance the development of HLX22 on a broad front across multiple indications," said Søren Bregenholt, CEO of Alligator Bioscience. "Conducting several clinical trials in parallel, including this Phase 2/3 study in breast cancer, demonstrates a clear strategic commitment and strong confidence in the molecule’s clinical and commercial potential. This further reinforces our view of the program’s long-term value."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, MAR 2, 2026, View Source [SID1234663167])

AIM ImmunoTech Signs Agreement for Planning of a Proposed Phase 3 Clinical Trial of Ampligen in the Treatment of Late-Stage Pancreatic Cancer

On February 2, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s anticipated Phase 3 clinical trial in the use of the Company’s drug Ampligen in the treatment of late-stage pancreatic cancer.

AIM CEO Thomas K. Equels states: "The ongoing Phase 2 DURIPANC clinical trial of Ampligen and AstraZeneca’s durvalumab in the treatment of late-stage pancreatic cancer is producing promising results. Based on the success so far, as well as anticipated final patient enrollment later this year, we believe it is now time to start mapping out the next steps for AIM’s development of Ampligen as a therapy for pancreatic cancer. AIM’s scientific team will work closely with Thermo Fisher’s experts in the design of a Phase 3 study and we look forward to their expertise and guidance in this critical endeavor. Pancreatic cancer is a deadly unmet medical need – and AIM believes that Ampligen could be a gamechanger in the treatment of pancreatic cancer."

AIM recently published an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders.

See: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer: Corporate Presentation – February 2026

AIM has thus far reported positive progress in Progression-Free Survival ("PFS"), Overall Survival ("OS") and safety in the DURIPANC study, which is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands.

See: AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and AstraZeneca’s Durvalumab in the Treatment of Metastatic Pancreatic Cancer

See: DURIPANC, Year-End Interim Clinical Progress Update

(Press release, AIM ImmunoTech, MAR 2, 2026, View Source [SID1234663166])

InnoCare’s next-generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in China

On March 1, 2026 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions. Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

Zurletrectinib has also been included in the "SPARK Program" by the CDE, a pilot initiative to encourage the development of pediatric anti-tumor drugs.

In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively.

In October 2025, the data from the Phase I/II clinical trial of zurletrectinib for the treatment of pediatric and adolescent patients with advanced solid tumors were released at the Congress of International Society of Pediatric Oncology (SIOP) 2025 as an oral presentation. Zurletrectinib demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors. The results highlight zurletrectinib’s strong potential as a next-generation therapy for NTRK/ROS1-driven malignancies, with the ability to overcome resistance to first-generation TRK inhibitors.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%1. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors diagnosed in China each year. There are significant unmet clinical needs in this area due to the lack of effective treatment options.

(Press release, InnoCare Pharma, MAR 1, 2026, View Source [SID1234663148])

XPOVIO® Receives Reimbursement Approval in South Korea for a Second Multiple Myeloma Indication

On March 1, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that South Korea’s National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) after one prior therapy. The reimbursement has taken effect on March 1, 2026. This marks the second XPOVIO indication to be approved for reimbursement in South Korea.

As Antengene continues to expand its footprint across the Asia Pacific region, the Company remains committed to improving patient access to its innovative therapies. To date, XPOVIO has been approved in South Korea for three indications in MM and diffuse large B-cell lymphoma (DLBCL), both major hematological malignancies. Two of these indications have been approved for reimbursement, including XPOVIO in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies, as well as the newly reimbursed indication. With expanded reimbursement coverage, XPOVIO is expected to benefit a broader patient population and further contribute to the management of hematological malignancies in South Korea.

With a novel mechanism of action, XPOVIO is the world’s first approved orally-available, selective XPO1 inhibitor. XPOVIO has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). Moving forward, Antengene will continue to pursue broader access for XPOVIO across APAC markets.

(Press release, Antengene, MAR 1, 2026, View Source [SID1234663147])

Jaypirca® (Pirtobrutinib) Approved in China for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

On March 1, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).[1],[2] Pirtobrutinib received approval from the U.S. FDA in January 2023 as a non‑covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL‑321 study. BRUIN CLL‑321 is the world’s first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator’s choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab). The results demonstrated that pirtobrutinib significantly prolonged median progression‑free survival (PFS) compared with the investigator’s choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment‑related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.[3]

Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL‑321 study in China, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, "BTK inhibitors have become the preferred first‑ or second‑line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis. Studies have shown that the median overall survival for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months.[4] Therefore, there is an urgent clinical need for new treatment. As a next‑generation, non‑covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL. The BRUIN CLL‑321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long‑term disease management in the future."

Dr. Li Wang, Lilly Corporate Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, states, "The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option. Supported by the efficacy and safety demonstrated in the BRUIN CLL‑321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting‑edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival. This is our enduring commitment to patients in China."

Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation. We will fully leverage Innovent’s leading brand presence and commercialization capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need."

About BRUIN CLL-321
BRUIN CLL-321 is a Phase 3, randomized, open-label study of Jaypirca versus investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in covalent Bruton tyrosine kinase (BTK) inhibitor pre-treated patients with relapsed and refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial enrolled 238 patients, who were randomized 1:1 to receive Jaypirca (200 mg orally, once daily) or investigator’s choice of either IdelaR or BR per labeled doses. This trial’s primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC). Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO).

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[2] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[5],[6]

In China, pirtobrutinib was developed by Eli Lilly and Company and is commercialized in mainland China by Innovent Biologics.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes.[7] In China, chronic lymphocytic leukemia (CLL) represents approximately 6%–7% of non-Hodgkin lymphoma cases.[8] SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells. In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes.

(Press release, Innovent Biologics, MAR 1, 2026, View Source [SID1234663146])