On August 22, 2026 Ixcell reported it has obtained implied approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for the clinical trial application of its independently developed IxCell PB-ZRAK Injection. The novel cell therapy product is indicated for the treatment of unresectable or metastatic advanced hepatocellular carcinoma (HCC) in patients with disease progression following standard-of-care therapies.

As a long-term strategic collaborator of IxCell, Medicilon provided comprehensive pharmacodynamic research services for IxCell PB-ZRAK Injection relying on its professional Cell and Gene Therapy (CGT) service platform. Through rigorous technical collaboration and joint efforts, the two parties have overcome multiple key technical challenges, facilitating a significant clinical advancement of cell therapy interventions for advanced liver cancer.

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Unmet Clinical Needs in Liver Cancer Treatment and Breakthrough Potential of Cellular Immunotherapy
Liver cancer poses a severe global public health burden, with China accounting for nearly 50% of newly diagnosed cases worldwide. According to the 2024 National Cancer Report, the country records 367,700 new liver cancer cases and 316,500 cancer related deaths annually, ranking the disease the fourth highest in incidence and the second highest in mortality across all malignancies. In terms of market prospects, the global liver cancer therapeutic market is projected to expand steadily from USD 4.6 billion in 2026 to USD 16.7 billion by 2035.
Conventional therapeutic regimens, including surgical resection, radiotherapy, chemotherapy and targeted therapy, have encountered inherent efficacy limitations in the treatment of advanced liver cancer. Cellular immunotherapy has emerged as a state-of-the-art therapeutic modality for advanced HCC, characterized by precise anti-tumor specificity, reliable safety profiles and broad patient applicability. The research innovation and clinical translation of novel immune cell therapeutics are of profound clinical significance for addressing unmet medical needs, while possessing considerable industrial and market value.
Dual-Mechanism Synergy: A Novel Therapeutic Solution for Advanced Liver Cancer
IxCell PB-ZRAK Injection is an innovative mixed immune cell formulation independently developed by IxCell based on its proprietary immune cell technology platform. The product exerts dual anti-tumor mechanisms: T cells achieve precise recognition and elimination of tumor cells, while NK cells deliver broad-spectrum cytotoxic effects, yielding superior therapeutic efficacy against liver cancer. PB‑ZRAK complements the company’s iPSC‑NK and other immune‑cell pipelines from both technical and product perspectives, further refining IxCell’s product portfolio in the field of tumor immunotherapy. Meanwhile, leveraging its iPSC‑based technology platforms, IxCell continues to expand into indications such as immune‑mediated diseases.
To date, IxCell has built three core R&D and technical systems for cell‑based therapeutics: mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and immune cells. These are backed by a compliant cGMP‑compliant manufacturing infrastructure. The company’s core pipelines are among China’s first‑tier cell‑therapy programs. Multiple cell‑therapy candidates have entered clinical development, with its lead MSC product advancing into late‑stage clinical trials.
The implied approval of IxCell PB-ZRAK Injection fully validates IxCell’s profound technical reserves and independent innovation capabilities in the cell therapy sector. Furthermore, this milestone marks the company’s strategic advancement from regenerative medicine to tumor immunotherapy, offering a promising novel therapeutic option for patients suffering from advanced liver cancer.
Medicilon’s Professional CGT Platform Accelerates Preclinical R&D of Innovative Cell Therapies
During the preclinical research phase of IxCell PB-ZRAK Injection, Medicilon’s pharmacodynamic R&D team systematically addressed core technical difficulties, including the biological heterogeneity of living cell therapeutics, immunosuppressive microenvironment characteristics of solid tumors, and insufficient clinical correlation of traditional animal models. The team successfully constructed an orthotopic Hep G2 liver cancer animal model and completed standardized, systematic pharmacodynamic evaluation studies, establishing a solid preclinical theoretical and experimental foundation for the product’s clinical approval.
As a pioneering CRO specializing in cell and gene therapy, Medicilon has built a mature and comprehensive CGT R&D service platform covering mainstream immune cell therapy technologies, including CAR-T, TCR-T, CAR-NK and TIL. The company provides one-stop integrated preclinical research services encompassing pharmacological and pharmacodynamic assessment, pharmacokinetic analysis, bioanalysis and drug safety evaluation. As of the end of June 2026, Medicilon has supported a total of 9 cell therapy drug candidates to obtain clinical trial approvals.

Medicilon extends its sincere congratulations to IxCell on the successful clinical approval of IxCell PB-ZRAK Injection. In the future, Medicilon will continue to iterate and upgrade its one-stop CGT preclinical R&D service system, accelerate the industrial translation of innovative cell therapy achievements, and facilitate the high-quality innovative development of global cell therapy pharmaceuticals.

(Press release, Shanghai Medicilon, AUG 22, 2026, View Source [SID1234670904])

On August 21, 2026 Werewolf Therapeutics, Inc. (Nasdaq: HOWL) and Ambros Therapeutics, Inc., reported that they entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Ambros Therapeutics’ neridronate development program in Complex Regional Pain Syndrome Type 1 ("CRPS-1", formerly known as Reflex Sympathetic Dystrophy). Upon completion of the merger, the combined company will operate as Ambros Therapeutics, headquartered in San Diego, California, and is expected to trade under the Nasdaq ticker symbol "AMBX".

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In connection with the proposed merger, the companies secured commitments for an oversubscribed concurrent private placement of $150 million from a syndicate of leading healthcare-dedicated investors co-led by RA Capital Management and Janus Henderson Investors. The private placement includes participation from Aberdeen Investments, Adage Capital Partners, L.P., ADAR1 Capital Management, Affinity Asset Advisors, LLC, Arkin Bio Capital, Balyasny Asset Management, Patient Square Capital’s platform Enavate Sciences, SilverArc Capital, Sphera Healthcare, and Woodline Partners LP as well as other new and existing investors. The private placement is expected to close concurrently with the proposed merger, at which time Werewolf Therapeutics will issue common stock and pre-funded warrants for aggregate gross proceeds of $150 million. Ambros Therapeutics expects the combined company to be fully funded through topline results from the pivotal CRPS-RISE Phase 3 clinical trial expected in 2028 and a planned New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("FDA") for potential approval of neridronate in patients with CRPS-1, with cash runway into the first half of 2029.

"We are uniquely positioned to be advancing neridronate, a differentiated bisphosphonate with extensive prior clinical experience, in an FDA-aligned single Phase 3 trial supporting potential regulatory approval in patients with CRPS-1, a debilitating orphan disease with no currently FDA-approved therapy," said Jay Hagan, Chief Executive Officer of Ambros Therapeutics. "With the capital raised through this financing from a leading investor syndicate, we expect to be fully funded through potentially value-generating topline results of our pivotal CRPS-RISE Phase 3 trial and have the resources to advance a potential NDA submission and commercial preparations. Our strengthened foundation resulting from today’s transformative announcement positions us to deliver value on behalf of patients, investors and all other stakeholders."

"Following a comprehensive review of strategic options, management and the board of directors believe a merger with Ambros Therapeutics is in the best interest of Werewolf Therapeutics’ stockholders. The Ambros management team’s extensive track record, drug development expertise and the potential of neridronate to deliver a meaningful treatment to patients with CRPS-1 is very compelling," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Neridronate, which has received the FDA’s Breakthrough Therapy, Fast Track, and Orphan Drug designations, is a differentiated bisphosphonate with the potential to redefine the standard of care for patients with CRPS-1."

Proceeds from the proposed transaction will be used to advance the clinical development of neridronate, a differentiated bisphosphonate that has demonstrated lasting pain reduction along with improvement in other CRPS-related symptoms.

Neridronate is advancing in the pivotal CRPS-RISE Phase 3 clinical trial ("CRPS-RISE"), a multicenter, randomized, triple-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of neridronate in patients with warm CRPS-1. CRPS-RISE leverages a precision medicine approach focused on diagnosed CRPS-1 patients in the warm-phase of the disease with positive triple-phase bone scans ("TPBS"), whose disease biology most closely aligns with neridronate’s proposed mechanism and where prior clinical evidence suggests the treatment effect may be greatest. The primary efficacy endpoint is change in pain intensity from baseline to week 12 as measured on an 11-point Numerical Rating Scale. Key secondary endpoints include other measures of pain reduction and patient reported outcomes. The program includes a registry for long-term outcomes and an opportunity for CRPS-RISE participants with active disease who completed the study to receive neridronate. Based on interactions with the FDA, Ambros Therapeutics believes that positive results from a single pivotal trial such as CRPS-RISE could support potential U.S. approval. Ambros Therapeutics anticipates reporting topline data from CRPS-RISE in 2028. Along with Orphan Designation, Ambros Therapeutics’ intellectual property portfolio supports the potential for neridronate’s U.S. market exclusivity through 2045.

About the Proposed Merger

Under the terms of the merger agreement, Werewolf Therapeutics will issue to pre-merger Ambros Therapeutics stockholders shares of Werewolf Therapeutics common stock (or pre-funded warrants in lieu thereof) as merger consideration in exchange for the cancellation of shares of capital stock of Ambros Therapeutics, and Ambros Therapeutics will become a wholly owned subsidiary of Werewolf Therapeutics. Stockholders of Ambros Therapeutics will receive newly issued shares of Werewolf Therapeutics common stock (or pre-funded warrants in lieu thereof) pursuant to a formula set forth in the merger agreement. The exchange ratio is based on an implied value of Ambros Therapeutics of $500 million (before giving effect to the concurrent private placement) and an implied value of Werewolf Therapeutics of $47.5 million. Pre-merger Werewolf Therapeutics stockholders (other than those investors participating in the private placement) are expected to own approximately 6.8% of the combined company, pre-merger Ambros Therapeutics stockholders are expected to own approximately 71.7% of the combined company and investors participating in the private placement are expected to own approximately 21.5% of the combined company. The percentage of the combined company that pre-merger Ambros Therapeutics stockholders and pre-merger Werewolf Therapeutics stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Werewolf Therapeutics’ net cash at the time of closing. In connection with the closing of the proposed transactions, Werewolf Therapeutics stockholders (other than those investors participating in the private placement) will also be issued a contingent value right representing the right to receive certain payments from net proceeds received by the combined company, if any, related to dispositions of Werewolf Therapeutics’ pre-transaction legacy assets.

The merger agreement has been approved by the boards of directors of both companies. The transaction is expected to close by the first quarter of 2027, subject to certain closing conditions, including the approval by the stockholders of each company, the shares of Werewolf Therapeutics common stock issuable in the transaction having been approved for listing on Nasdaq, effectiveness of the registration statement on Form S-4 (the "Form S-4") and the satisfaction of other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Werewolf Therapeutics with the Securities and Exchange Commission (the "SEC") and will be available at www.sec.gov.

Leerink Partners, Piper Sandler, Cantor and Wells Fargo Securities are serving as placement agents for the concurrent private placement. LifeSci Capital is also serving as a placement agent. Cooley LLP is serving as legal counsel to Ambros Therapeutics. Piper Sandler is serving as the exclusive financial advisor, and Sidley Austin LLP is serving as legal counsel, to Werewolf Therapeutics. Latham & Watkins LLP is serving as legal counsel to the placement agents.

Management and Organization

Upon closing of the proposed transaction, the combined company will be led by current members of the Ambros Therapeutics leadership team including:

Joseph (Jay) Hagan, Chief Executive Officer
Cris Calsada, Chief Financial Officer
Gail Cawkwell, M.D., Ph.D., Chief Medical Officer
Christopher Aker, General Counsel
Kunal Kishnani, SVP of Corporate Development
Members of Ambros Therapeutics’ existing board of directors will become directors of the combined company.

About Neridronate

Neridronate is a differentiated bisphosphonate that was developed by Abiogen Pharma S.p.A. Neridronate is approved and marketed in Italy for the treatment of Complex Regional Pain Syndrome ("CRPS"); clinical studies have demonstrated lasting pain reduction along with improvements in other CRPS related symptoms. Beyond CRPS, neridronate is also approved in Italy for osteogenesis imperfecta and Paget’s disease and has been administered to approximately 600,000 patients across approved indications. Its well-established safety and tolerability profile and therapeutic benefits make it a potential promising treatment for patients with CRPS-1 worldwide. Recognizing its potential, the FDA has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for the treatment of CRPS.

About CRPS-1

CRPS-1 is a severely painful, debilitating orphan disease typically following a limb injury affecting an estimated 65,000 newly diagnosed people in the United States each year. There are currently no FDA-approved medicines available to treat this high unmet need patient population. The condition is characterized by intense pain that can be continuous in the affected limb such as the arm, leg, hand or foot. Patients with CRPS-1 often experience an evolving condition commencing with a "warm" phase that typically predominates in the first year after onset where inflammation and other mechanisms cause the affected limb to become red, swollen, warm, and hypersensitive to pain. In many patients, the disease progresses to a chronic "cold" phase, where the affected limb changes its presentation and patients face ongoing, debilitating pain.

About CRPS-RISE

CRPS-RISE is a Phase 3, multicenter, randomized, triple-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of neridronate in patients with warm CRPS-1. The trial will evaluate approximately 270 participants randomized 1:1 to receive either intravenous ("IV") neridronate or placebo. To be eligible for the trial, participants must have a confirmed CRPS-1 diagnosis per the Budapest Clinical Criteria, a known precipitating event (e.g. fracture, sprain, contusion), CRPS-1 duration of 6 months or less and moderate to severe pain. Additionally, participants must have characteristics that Ambros Therapeutics believes make them more likely responders to neridronate treatment: a positive triple phase bone scan and specific attributes of the warm CRPS-1 subtype. Following an initial screening period of two to six weeks, participants will receive four IV infusions over 10 days of either 100 mg neridronate (400 mg total dose) or placebo followed by a post-treatment period through week 12. The primary efficacy endpoint is change in pain intensity from baseline to week 12 as measured on an 11-point Numerical Rating Scale. Key secondary endpoints include other measures of pain reduction and patient reported outcomes. The program includes a registry for long-term outcomes and an opportunity for CRPS-RISE participants with active disease who completed the study to receive neridronate.

(Press release, Werewolf Therapeutics, AUG 21, 2026, View Source [SID1234670281])

On August 21, 2026 Johnson & Johnson reported that the European Commission (EC) has approved an indication extension for TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.

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Complementary mechanisms of action underpin this immunotherapy doublet

Teclistamab and daratumumab work in a complementary manner, with daratumumab modulating the immune system to enhance T-cell fitness and activation, thereby amplifying teclistamab-mediated killing of myeloma cells.1,2

Expert and company perspectives on advancing the standard of care in RRMM

"Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important," said María-Victoria Mateos, M.D., Director of the Myeloma Unit at the University Hospital of Salamanca, Spain. "Today’s approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line."

"This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma," said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients."

"Today’s approval reflects our ongoing commitment to addressing the diverse needs of patients with multiple myeloma, giving them more options at every stage of their disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By continuing to invest in scientific innovation and practice-changing research, we aim to redefine what is possible for patients today, while moving closer to a future where long-term disease control, and ultimately cure, becomes an achievable goal."

Unprecedented Phase 3 study data demonstrate significant survival benefits versus standard of care, representing a potential new benchmark in RRMM

The EC approval is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), which evaluated the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with RRMM who have received 1–3 prior lines of therapy.3

Source: Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine 2025; Full article and supplementary material. Available at: View Source Last accessed: August 2026.

The study demonstrated clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS).1 At nearly three years of follow-up, teclistamab plus daratumumab SC reduced the risk of disease progression or death by 83.4% compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.001).1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, highlighting the durability of response observed with this regimen.1 OS favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.1,2 At three years, OS rates were 83.3% for the combination compared with 65.0% for standard of care.1

Teclistamab combination demonstrated manageable safety profile

The safety profile of teclistamab plus daratumumab SC was consistent with the well-known profiles of the individual therapies and no new safety signals were identified.1,4,5 All cases of cytokine release syndrome were Grade 1/2 and did not lead to treatment discontinuation.1 Cytopenia and infection were the most commonly observed Grade 3/4 treatment-emergent adverse events (TEAEs).1 Treatment discontinuations due to TEAEs were low and occurred at similar rates between study arms (4.6% [teclistamab] vs. 5.5% [DPd/DVd]).1

About the MajesTEC-3 Study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.1,3 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.3 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.3

About Teclistamab

Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.4,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.1,5 Teclistamab is currently being evaluated in several combination studies.4,9,10,11

To date, more than 30,700 patients have been treated worldwide with teclistamab.12

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.4

About Daratumumab and Daratumumab SC

Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide.13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.5

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.5 Daratumumab may also have an effect on normal cells.5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, AUG 21, 2026, View Source [SID1234670280])

On August 21, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi (durvalumab), and AVT87, a proposed biosimilar to Hemlibra (emicizumab).

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Imfinzi is an oncology biologic used in the treatment of multiple cancers, which generated global sales of approximately $6.1 billion in 2025¹. Hemlibra is a biologic for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A that generated global sales of approximately CHF4.8 billion (approximately $5.8 billion) in 2025².

Under a semi-exclusive agreement in the United States, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through Alvogen, its U.S.-based wholly owned subsidiary. Alvotech will retain responsibility for product development, and for obtaining and maintaining marketing authorizations in the United States, and will serve as the exclusive supplier of the products for all markets.

In Asia, Lotus will have exclusive commercialization rights in eight selected markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. Lotus will be responsible for local regulatory submissions and commercialization in these markets.

The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, in addition to ongoing revenues from the supply of commercial product.

"This agreement represents an important evolution of Alvotech’s commercial strategy," said Lisa Graver, Chief Executive Officer of Alvotech. "For the first time, we will have the opportunity to participate directly in the future commercialization of our products in the United States, allowing us to retain a greater share of the value we create through our development and manufacturing platform. At the same time, our partnership with Lotus extends the potential reach of these two important pipeline assets across key Asian markets. We look forward to working together to bring these medicines to patients and broaden access to high-quality biologics."

"We are pleased to partner with Alvotech on two important biosimilar candidates that meaningfully advance Lotus’ global growth strategy," said Petar Vazharov, Chief Executive Officer of Lotus. "By combining Alvotech’s integrated biosimilar development and manufacturing capabilities with Alvogen’s established U.S. commercial platform and Lotus’s deep market presence across Asia, we are building a strong foundation for the future commercialization of AVT34 and AVT87 across key global markets. These candidates expand the scale and reach of our biosimilar portfolio in oncology and rare diseases, and reinforces our commitment to broadening access to high-quality medicines."

Imfinzi and Hemlibra are registered trademarks and the property of their respective owners.

(Press release, Alvotech, AUG 21, 2026, View Source [SID1234670279])

On August 21, 2026 Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the latest clinical data on its novel epidermal growth factor receptor (EGFR) inhibitor ZEGFROVY (sunvozertinib) in non-small cell lung cancer (NSCLC) will be presented at the 2026 World Conference on Lung Cancer (WCLC) from September 12 to 15 in Seoul, Republic of Korea.

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ZEGFROVY is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. In addition, with positive results from WU-KONG28, a multinational randomized Phase 3 study in treatment naïve patients, the Supplemental New Drug Application (sNDA) of ZEGFROVY as first-line treatment has been submitted to China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA). On July 14, Dizal announced that it entered into an exclusive license agreement granting AstraZeneca global rights to develop and commercialize ZEGFROVY. The transaction is expected to close in the second half of 2026.

At WCLC 2026, Dizal will present the latest findings from a study evaluating ZEGFROVY as adjuvant treatment in patients with resected stage IB-IIIB EGFR exon20ins NSCLC. Promising efficacy results strengthen its potential as an earlier treatment option. No new safety signals have been observed. Based on these findings, a randomized pivotal study is ongoing.

In addition, Dizal will report updated data from a Phase 2 study evaluating ZEGFROVY in combination with Anlotinib as first-line treatment for NSCLC with EGFR sensitizing mutations and co-mutations. This oral chemotherapy-free combination regimen continues to exhibit robust anti-tumor activity and a manageable safety profile.

The details of the presentation are shown below:

Lead Author

Abstract Title

Presentation Details

Prof. Chang Chen

Efficacy and Safety of Sunvozertinib as Adjuvant
Treatment in Resected Stage IB-IIIB EGFR Exon 20
Insertion Mutated NSCLC

Abstract Number: P1.159

Poster Session

10:30 AM – 12:00 PM (KST /
UTC +9), Sep 13, 2026

Prof. Yongchang Zhang

Sunvozertinib Plus Anlotinib as First-line Treatment for
NSCLC with EGFR Sensitive Mutations and Co-
mutations: Updated Phase II Data

Abstract Number: P3.207

Poster Session

9:30 AM – 11:00 AM (KST /
UTC +9), Sep 15, 2026

About ZEGFROVY (sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by the results of WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. The sNDA for ZEGFROVY as first-line treatment in NSCLC patients with EGFR exon20ins has been submitted to the China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. Both China CDE and the US FDA have granted Breakthrough Therapy Designation to ZEGFROVY in this setting.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable.

(Press release, Dizal Pharma, AUG 21, 2026, View Source [SID1234670278])