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China’s First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent’s TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval

On December 25, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the New Drug Application (NDA) for TABOSUN (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China’s National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN (ipilimumab N01 injection) is the world’s first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer.

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Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis

MSI-H/dMMR colon cancer accounts for around 15% of all resectable colon cancer cases[ii]. Due to its unique biological characteristics, this class of tumor shows limited sensitivity to chemotherapy and generally responds poorly[iii]. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in advanced MSI-H/dMMR colon cancer, but a gap remains in the neoadjuvant setting. For locally advanced MSI-H/dMMR colon cancer, the current standard of care is direct surgery followed by adjuvant chemotherapy. Under this regimen, approximately 10%-30% of patients experience disease recurrence or metastasis after surgery, while chemotherapy-related toxicities may negatively affect quality of life[iv]. Thus in the neoadjuvant setting, there remains an urgent need for more effective therapies to improve outcomes for patients with locally advanced MSI-H/dMMR colon cancer.

The world’s first dual-IO neoadjuvant therapy: TABOSUN (ipilimumab N01 injection) combined with TYVYT (sintilimab injection) markedly enhances pathological complete response rates

Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed cancer treatment. The combination of DABOSUN (ipilimumab N01 injection) and TYVYT (sintilimab injection) as neoadjuvant therapy can significantly improve pathological complete response(pCR) rates and allow the majority of patients to avoid adjuvant chemotherapy.

Previously, results from a randomized, controlled Phase 1b trial evaluating ipilimumab N01 plus sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were published in the top-tier journal Cancer Cell[i].

As of June 17, 2025, 101 patients were enrolled and randomized to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49).
In the per-protocol population, the pCR rate in the ipilimumab N01-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm (80.0% vs 47.7%, p=0.0007).
With median follow-up of 21.4 months, no patient experienced disease recurrence.
Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pCR rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the NeoShot trial met its primary endpoint.

As of November 28, 2024, among the first 50 patients in the treatment arm, 41 achieved pathological complete response after neoadjuvant treatment, yielding a pCR rate of 82%.
Neoadjuvant treatment with ipilimumab N01 combined with sintilimab did not significantly increase safety risks compared with direct surgery.
Detailed results will be presented at future academic conferences or published in academic journals.

The Principal Investigator of the NeoShot study, Academician of the Chinese Academy of Engineering, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "Achieving R0 resection remains challenging for certain patients with locally advanced colon cancer, who also face substantial surgical trauma and poor prognosis. Results from the FOxTROT study indicated that neoadjuvant chemotherapy provides limited benefit in MSI-H/dMMR colon cancer, with a pCR rate of only around 5%[v]. The NeoShot trial is the first randomized, controlled Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Interim analysis suggests that ipilimumab N01 with sintilimab as short-term neoadjuvant treatment can lead to pathological complete response in 82% of treated patients. In addition, NeoShot Ph1b and Ph3 interim results both show the R0 resection under this regimen could reach 100% and spare patients from adjuvant chemotherapy. In NeoShot-1b, the dual-immunotherapy neoadjuvant regimen combining ipilimumab N01 and sintilimab significantly improved the pCR rate, which serves as a surrogate endpoint for long-term prognosis. Based on the existing data, this regimen shows promising potential to reduce recurrence risk and improve long-term survival outcomes. We look forward to observing continued reductions in recurrence with longer-term follow-up. The approval of this dual-immunotherapy regimen is expected to change clinical practice, fill a critical gap in neoadjuvant treatment of colon cancer and benefit more patients with MSI-H/dMMR colon cancer."

Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "There remains a substantial unmet clinical need for neoadjuvant therapies for stage IIB-III resectable MSI-H/dMMR colon cancer in China. Interim analysis has shown that the NeoShot trial met its primary endpoint. Through Innovent’s efficient and high-quality clinical development, ipilimumab N01 has become China’s first domestically developed innovative CTLA-4 inhibitor approved by the NMPA, offering a new treatment option for patients in China with stage IIB-III resectable MSI-H/dMMR colon cancer."

About Ipilimumab N01

Ipilimumab N01 (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab N01 specifically binds cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4-mediated inhibition of T cell activity, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. [vi]

The NDA for ipilimumab N01 in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer has recently been approved by the NMPA.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[vii]

In China, sintilimab has been approved and included in the updated NRDL for eight indications. The updated NRDL reimbursement scope for TYVYT (sintilimab injection) includes:

For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; and
In combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.
The NDA for sintilimab’s ninth indication, in combination with ipilimumab N01 as neoadjuvant treatment for stage IIB-III resectable MSI-H/dMMR colon cancer is recently approved by the NMPA.

The NDA for sintilimab’s tenth indication, in combination with fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma who previously failed systematic treatment, has been accepted by the Center for Drug Evaluation (CDE) of NMPA.

In addition, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; and
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy.

(Press release, Innovent Biologics, DEC 25, 2025, View Source [SID1234661627])

ABL Bio Receives Upfront Payment for License, Research and Collaboration Agreement for Grabody Platform and Equity Investment from Lilly

On December 25, 2025 ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, reported that ABL Bio will receive a USD 40 million upfront payment for the license, research and collaboration agreement for its Grabody platform, and a USD 15 million equity investment from Eli Lilly and Company ("Lilly").

ABL Bio and Lilly are currently conducting joint research and development on multiple therapeutic candidates leveraging the Grabody platform across various modalities.

In parallel with strengthening its collaboration with Lilly, ABL Bio plans to accelerate R&D on its core technologies—including the bispecific antibody platform ‘Grabody’, bispecific ADCs, and dual-payload ADCs—using the newly secured funding.

Sang Hoon Lee, CEO of ABL Bio said, "With the completion of the relevant administrative procedures, including the HSR Act, ABL Bio will receive the upfront payment and equity investment from Lilly. The company plans to use the newly secured funding to expand the indications of its Grabody platform into high-unmet-need areas such as obesity and muscle disorders. ABL Bio also intends to extend clinical development of its bispecific immuno-oncology candidates into combination therapies and focus on advancing next-generation ADC programs."

Meanwhile, on November 12 and 14, ABL Bio signed a license, research and collaboration agreement for Grabody platform with Lilly valued at USD 2.602 billion (including a USD 40 million upfront payment), as well as a USD 15 million equity investment agreement. Based on these agreements, ABL Bio explores a broad range of collaborative opportunities with Lilly to develop therapies from a long-term perspective.

(Press release, ABL Bio, DEC 25, 2025, View Source [SID1234661626])

Italfarmaco and JCR Pharmaceuticals Announce Commercialisation Agreement for Givinostat in Japan and Strategic Collaboration in Rare Disease

On December 24, 2025 Italfarmaco S.p.A. and JCR Pharmaceuticals Co., Ltd. (TSE 4552; "JCR"), reported an exclusive licensing agreement for the development and commercialisation of givinostat in Japan.

Under the terms of the agreement, JCR receives exclusive rights to commercialise givinostat for the treatment of Duchenne muscular dystrophy (DMD) in Japan and will be responsible for the local execution of clinical development activities, as well as regulatory submissions.

Givinostat (marketed as Duvyzat in the US, UK and EU) is an orally administered histone deacetylase inhibitor developed by Italfarmaco to treat DMD, regardless of the underlying dystrophin gene mutation. It has obtained regulatory authorisation across several major markets, including the US, EU and the UK; it is currently not approved in Japan.

The agreement also establishes a broader strategic collaboration between the two companies to explore joint opportunities for the treatment of rare diseases.

"This partnership is a key milestone in our global strategy to expand access to givinostat and deepen our impact in rare diseases," said Antonio Nardi, Vice President and Head of Business & Portfolio Development of Italfarmaco. "JCR’s commitment to innovation, strong local expertise, and focus on patient-centred science make them an ideal partner for the expansion of our rare disease portfolios, not only in Japan, but also globally."

"Partnering with Italfarmaco is an important step for JCR as we enter the next phase of our growth and may be the first step in a long-lasting relationship between both companies that may extend into future research and development partnerships and cross-licensing opportunities," said Shin Ashida, Chairman, President and CEO of JCR Pharmaceuticals. "We remain dedicated to developing therapies for the rare disease community, and givinostat extends this commitment to an even broader group of patients with rare diseases in Japan."

Francesco De Santis, Chairman of Italfarmaco Group, added: "By joining forces with JCR, we are expanding access to an important DMD therapy for the Japanese Duchenne community and also laying the groundwork for future innovations in rare diseases. Together, we are committed to delivering meaningful solutions where they are needed most."

About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy (DMD) is a rare, progressive neuromuscular disorder caused by mutations in the dystrophin gene. These mutations prevent the production of functional dystrophin, causing the dystrophin-associated protein complex (DAPC) to break down. This makes muscle fibres more vulnerable to damage and increases histone deacetylase (HDAC) levels in the muscle cells, blocking the activation of important genes needed for muscle maintenance and repair. As a result, muscle fibres experience ongoing damage, leading to chronic inflammation and poor regeneration. Over time, muscle cells die and are replaced by scar tissue and fat.1-4 DMD primarily affects males, with symptoms typically appearing between the ages of two and five years. As the condition progresses, muscle weakness worsens, leading to difficulty walking and eventually loss of ambulation. Over time, the heart and respiratory muscles are also affected, which are the leading causes of premature death.5 DMD is one of the most severe and common forms of childhood muscular dystrophy, with a global birth incidence of approximately 1 in 5,050 boys.6 DMD affects an estimated 3,500 patients in Japan.7

About Givinostat
Givinostat (Duvyzat) was discovered through Italfarmaco’s research and development efforts in collaboration with Telethon and Duchenne Parent Project (Italy). Givinostat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle. Givinostat’s mechanism of action inhibits HDAC pathological overactivity in an effort to address the cascade of events leading to muscle damage, thereby counteracting the disease pathology and slowing down muscle degeneration.

(Press release, Italfarmaco, DEC 24, 2025, View Source [SID1234661624])

Repare Therapeutics Announces Acquisition of Polθ ATPase Inhibitor, RP-3467, by Gilead Sciences for Up To $30 Million in Total Consideration

On December 24, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported a definitive asset purchase agreement for Gilead Sciences, Inc. to acquire Repare’s polymerase theta (Polθ) ATPase inhibitor, RP-3467 (the "Gilead Agreement").

"We are pleased to announce this transaction which combines Gilead’s leading expertise in oncology research and development with RP-3467, a potential best-in-class Polθ ATPase inhibitor," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "This marks the third and most significant portfolio transaction for Repare this year."

Under the terms of the Gilead Agreement, Repare will receive up to $30 million in total consideration, including a $25 million upfront payment, subject to customary holdbacks and adjustments, and an additional $5 million payment upon completion of specified technology transfer activities.

On November 14, 2025, Repare announced that it had entered into a definitive arrangement agreement (the "Arrangement Agreement") with XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly, "Xeno"), pursuant to which Xeno will acquire (the "Arrangement Transaction") all of the issued and outstanding common shares of Repare (the "Common Shares"). Under the terms of the Arrangement Agreement, Repare shareholders will receive a cash payment per Common Share that will be determined based upon Repare’s cash balance at closing of the Arrangement Transaction (the "Arrangement Closing") after deducting certain transaction costs and the aggregate amount of outstanding liabilities (the "Closing Net Cash Amount").

The upfront portion of the consideration payable under the Gilead Agreement has increased Repare’s cash balance and, therefore, has also increased the estimated Closing Net Cash Amount. Based on Repare’s revised estimate of the Closing Net Cash Amount, it is now currently estimated that each Repare shareholder will receive a cash payment of approximately US$2.20 per Common Share at the Arrangement Closing.

About RP-3467.

RP-3467 is a highly potent, small molecule inhibitor of Polθ that is a synthetic lethality target associated with BRCA mutations and other genomic alterations. RP-3467 is being evaluated in the POLAR Phase 1 clinical trial to evaluate its safety, pharmacokinetics, pharmacodynamics and preliminary activity alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer or pancreatic adenocarcinoma.

(Press release, Repare Therapeutics, DEC 24, 2025, View Source [SID1234661623])

Sanofi to Acquire Dynavax, Adding a Marketed Adult Hepatitis B Vaccine and Phase 1/2 Shingles Candidate to the Pipeline

On December 24, 2025 Sanofi reported that it has entered into an agreement to acquire Dynavax Technologies Corporation (Nasdaq: DVAX), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B) and a differentiated shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s vaccines with Sanofi’s global scale, development capabilities and commercial reach.

Dynavax’s adult hepatitis B vaccine HEPLISAV-B is currently marketed in the US and is differentiated by its two-dose regimen over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses over six months.

The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in phase 1/2 clinical development, and additional vaccine pipeline projects.

"Dynavax enhances Sanofi’s adult immunization presence by adding differentiated vaccines that complement Sanofi’s expertise," said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. "Its marketed adult hepatitis B vaccine and shingles candidate bring new options to our portfolio and underscore our commitment to providing vaccine protection across the lifespan."

"Joining Sanofi will provide the global scale and expertise needed to maximize the impact of our vaccine portfolio," said Ryan Spencer, Chief Executive Officer, Dynavax. "We believe Sanofi’s commercial reach, development capabilities and commitment to evidence-based immunization will amplify the opportunity for HEPLISAV-B and our innovative pipeline to address important public health needs, further advancing our mission to help protect the world against infectious disease. We are confident that this transaction – and the compelling value it provides – is in the best interests of the Company and its stockholders."

Dynavax believes hepatitis B and shingles represent a significant public unmet health need and adult vaccination opportunities. In the US alone, nearly 100 million adults born before 1991 remain unvaccinated, with many potentially at risk for infection. Chronic infection with the hepatitis B virus can cause liver damage and lead to cirrhosis and liver cancer. Shingles, which is caused by the varicella zoster virus, affects one in three adults over their lifetime, according to the World Health Organization. In most people shingles causes a painful, itchy rash, but in some cases it can lead to long-term nerve pain, serious eye infections that can damage the vision and, rarely, dangerous inflammation of the brain.

Financial considerations
Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion.

The offer price represents a premium of approximately 39% over the closing price of Dynavax on December 23, 2025 and a premium of approximately 46% over the 3-month volume-weighted average price (VWAP) of Dynavax as of December 23, 2025.

The transaction has been unanimously approved by the Dynavax board of directors. The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Dynavax common stock that represent at least a majority of the outstanding shares of Dynavax common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, certain foreign regulatory filings and clearances and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer.

Sanofi plans to fund the acquisition with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close in the first quarter of 2026.

Centerview Partners LLC and Goldman Sachs & Co. LLC are acting as financial advisors to Dynavax, and Cooley LLP is acting as its legal counsel.

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s vaccine adjuvant, a toll-like receptor (TLR) 9 agonist, to enhance the immune response.

HEPLISAV-B is a shot given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV-B is usually given in the arm muscle. HEPLISAV-B is given in two doses, one month apart, by a healthcare provider.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV-B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.

It is not known whether HEPLISAV-B is excreted in human milk.

Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.

Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.

(Press release, Sanofi, DEC 24, 2025, View Source [SID1234661622])