On June 19, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of neurofibromatosis type 2 (NF2) for the anti-cancer agent/humanized anti-VEGF*1 monoclonal antibody Avastin Intravenous Infusion 100 mg/4 mL and 400 mg/16 mL [generic name: bevacizumab (genetical recombination)] (hereinafter, "Avastin"). Avastin is the first drug approved in the world for the treatment of this disease.

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"We are very pleased to deliver Avastin as the world’s first therapeutic drug for neurofibromatosis type 2 in Japan. NF2 is a rare disease that causes symptoms such as hearing loss and dizziness, significantly impacting patients’ daily lives, and there has been a strong need for effective treatment options. Avastin represents a new therapeutic option, suggesting potential for the maintenance or improvement of hearing and a trend toward tumor reduction. We will continue our efforts to promptly provide appropriate use information so that we can contribute to patient treatment and improvement in quality of life," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from the investigator-initiated Japanese Phase II clinical study, the BeatNF2 study, which evaluated the efficacy and safety of Avastin in NF2.

Approval Information *Relevant sections only, with modifications underlined

Indications:
◯ Unresectable advanced or recurrent colorectal cancer
◯ Unresectable advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma
◯ Inoperable or recurrent breast cancer
◯ Malignant glioma
◯ Ovarian cancer
◯ Advanced or recurrent cervical cancer
◯ Unresectable hepatocellular carcinoma
◯ Neurofibromatosis type 2

Dosage and Administration:

The usual adult dosage is 5 mg/kg (body weight) of bevacizumab (genetical recombination) administered by intravenous infusion every two weeks.

[Reference Information]

Chugai Files for Additional Indication of Avastin for the Treatment of Neurofibromatosis Type 2 (News release dated September 24, 2025)
View Source

About the BeatNF2 study

The BeatNF2 study (FMU2019-01-NF2 study / jRCT2080224914) is an investigator-initiated, multicenter, domestic Phase II, placebo-controlled, double-blind, randomized clinical study conducted in Japan to evaluate the efficacy and safety of Avastin in patients with NF2, a rare hereditary disease. Twelve institutions in Japan, including Fukushima Medical University Hospital, participated in the study.
The study enrolled 62 patients. During the initial treatment period, Avastin or placebo was administered every two weeks through week 22. From week 24 to week 46, all patients received Avastin every two weeks. During the follow-up period, Avastin could be administered up to six times if the attending physician judged disease progression.
The primary endpoint, "the proportion of patients with improved hearing at 24 weeks after treatment initiation compared to baseline, based on the evaluation using maximum speech discrimination score*2," was 16.1% (5/31; 95% CI: 5.5-33.7) in the Avastin group and 3.2% (1/31; 95% CI: 0.1-16.7) in the placebo group, with no statistically significant difference (P = 0.0858). Meanwhile, improvement in hearing measures and a trend toward reduction in tumor volume, a secondary endpoint, were suggested during the treatment period. Regarding safety, adverse reactions were observed in 57.4% (35/61) of patients who received Avastin, and hypertension was the most common adverse reaction at 18.0% (11/61).

*1 VEGF：Vascular Endothelial Growth Factor
*2 Maximum speech discrimination score is an indicator of speech comprehension ability. It refers to the percentage of correct answers in a monosyllabic word recognition test at the volume level that yields the highest accuracy while adjusting sound intensity. The higher this value, the better one’s ability to accurately understand speech when sounds are audible. It also serves as a measure for evaluating the effectiveness of hearing aids.

About the Neurofibromatosis Type 2 (NF2)1

NF2 is an autosomal dominant hereditary disease characterized by bilateral acoustic nerve tumors (vestibular schwannomas). Symptoms associated with these tumors include hearing loss, dizziness, unsteadiness, and tinnitus. Additionally, symptoms related to spinal schwannomas may include numbness, sensory impairment, and weakness in the limbs.
Management of vestibular schwannomas includes observation, surgery, and radiation therapy. While these tumors are benign and may show minimal growth, surgical removal may be performed when symptoms develop or tumor growth is evident, which may affect long-term prognosis. Preservation of hearing through surgery is difficult, and there remains a risk of postoperative neurological complications.
According to overseas reports, NF2 is a rare disease with an incidence of approximately 1 in 25,000 to 60,000 individuals. In Japan, approximately 800 patients submitted clinical registry data between 2009 and 2013. Onset is most common in individuals in their teens to twenties.

About Avastin

Avastin is an antibody medicine that binds specifically to VEGF2, which plays an important role in angiogenesis essential for tumor growth and metastasis, thereby inhibiting its activity. In Japan, Avastin was launched in June 2007 and is positioned as one of the standard therapies in treatment guidelines for various cancers. It has been approved for seven indications: unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent non-squamous non-small cell lung cancer, inoperable or recurrent breast cancer, malignant glioma, ovarian cancer, advanced or recurrent cervical cancer, and unresectable hepatocellular carcinoma.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 19, 2026, View Source [SID1234668811])

On June 19, 2026 Fapon Biopharma, a clinical-stage biotech company innovating therapeutic antibodies and fusion proteins, and MOTE Therapeutics, a preclinical-stage biotech company developing a novel targeted LNP delivery platform and in vivo CAR-T therapies, reported their participation in the BIO International Convention 2026, taking place June 22–25 at the San Diego Convention Center. Both companies are members of Fapon Group. They will present their dual-targeting (CD19×BCMA), dual-platform (TCE + in vivo CAR-T) franchise designed to achieve deep and durable B-cell depletion through complementary therapeutic modalities, with both assets advancing toward human trials in the next six months.

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The companies will exhibit at Booth 5435-2 in the Shanghai Pudong Pavilion, highlighting their complementary technology platforms, innovative pipeline across immuno-oncology and autoimmune diseases, and global partnership opportunities.

Two proprietary technology platforms serve as the engine behind this pipeline. Fapon Biopharma brings its proprietary VHH human-cynomolgus cross-binding T-cell engager platform, an innovative approach designed to overcome developability and therapeutic window constraints associated with traditional multi-specific immune cell engagers, featuring human-cynomolgus cross-reactivity, scalable GMP manufacturing with proven cell line development, and versatile molecular design. MOTE Therapeutics’ breakthrough mobilize targeted LNP (tLNP) platform is a next-generation in vivo gene delivery system that enables cell-specific targeted delivery and extrahepatic tissue distribution through a non-covalent, modular surface functionalization approach that requires no chemical conjugation.

The companies’ B-cell depletion franchise takes center stage at BIO 2026. This franchise features two differentiated programs targeting CD19 and BCMA, designed to deliver potent and sustained B-cell depletion: FPE024, a potential best-in-class CD19×BCMA×CD3 tri-specific T-cell engager for autoimmune indications, with IND filing targeted Q1 2027; and MTX001, a CD19×BCMA in vivo CAR-T program powered by the mobilize tLNP platform, with an investigator-initiated first-in-human study expected in Q4 2026.

In addition to the B-cell depletion franchise, the companies have built a robust pipeline spanning discovery, preclinical and clinical stages. Leading the clinical-stage pipeline is FP008, a global first-in-class PD1×IL10M fusion protein for immuno-oncology, currently in Phase I development with key readout anticipated in 2026. FP012 is a global first-in-class TL1A×IL10MM fusion protein for inflammatory bowel disease and other inflammatory and autoimmune indications. FPE021 is a potential best-in-class CDH17-targeting T-cell engager with a second co-stimulation signal for gastrointestinal tract cancers. Both FP012 and FPE021 are entering IND-enabling CMC/GLP toxicology in 2026.

Attendees interested in the science behind these programs can gain deeper insights during a dedicated company presentation, titled "Building a Dual-Targeting / Dual-Platform Franchise for B-Cell Immunotherapy" on Monday, June 22 at 4:30 PM PT in Room 3. The session will detail the technical design, development roadmap and commercial potential of the companies’ integrated dual-platform strategy for B-cell immunotherapy.

(Press release, Fapon Biopharma, JUN 19, 2026, View Source [SID1234668812])

On June 19, 2026 Incyte Biosciences Japan G.K. reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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"This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. "We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer."

DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant.1

The approval is based on results from the MOR208C203 Trial: L-MIND (NCT02399085), an international Phase II trial, and INCMOR 0208-102 Trial Part 4 (Group 6): J-MIND (NCT04661007), a domestic Phase Ib/II trial in Japan, both of which evaluated the safety and efficacy of Minjuvi in combination with lenalidomide in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).2,4 In the L-MIND trial, based on an independent review committee assessment (data cutoff date: November 20, 2018), the overall response rate (ORR) was 58.8% (primary endpoint), with a complete response (CR) rate of 41.3% and a partial response (PR) rate of 17.5%.3 The median duration of response (mDOR) had not been reached at a median follow-up of 44 months or more.3 Furthermore, based on the independent review committee’s assessment in the J-MIND trial (data cutoff date: August 31, 2023), the response rate was 71.4%, with a complete response (CR) rate of 45.2% and a partial response (PR) rate of 26.2%.4 The main adverse events included neutropenia and thrombocytopenia.4,5 Overall, Minjuvi in combination with lenalidomide demonstrated a clinically meaningful response, and the side effects were manageable.4,5

This approval represents the second regulatory approval for Minjuvi in Japan. Minjuvi in combination with rituximab and lenalidomide was previously approved by the MHLW for the treatment of adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

About L-MIND
L-MIND was a single-arm, open-label Phase 2 study evaluating tafasitamab in combination with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma who had received at least one, but no more than three, prior lines of therapy (including an anti-CD20 therapy such as rituximab) and who were not eligible for, or refused, high-dose chemotherapy followed by autologous stem cell transplant.2 The primary endpoint was overall response rate; secondary endpoints included duration of response, progression-free survival, and overall survival.2

For more information about the study, please visit View Source

About J-MIND
J-MIND Trial Part 4 (Group 6) (NCT04661007) is a Japanese Phase Ib/II clinical trial evaluating the efficacy and safety of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients enrolled in this trial had received one to three prior systemic therapies, including CD20-targeted therapy, and were deemed by the principal investigator to be ineligible for or unresponsive to autologous hematopoietic stem cell transplantation.4

The primary endpoint of this trial was the objective response rate (ORR) as assessed by an independent review committee based on the Lugano criteria; secondary endpoints included complete response (CR), progression-free survival (PFS), and overall survival (OS).4

For more information about the study, please visit View Source

About Minjuvi (tafasitamab)
Minjuvi (tafasitamab) is a humanized, Fc-modified, cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).6 Additionally, Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).6

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.7 Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one line of systemic therapy in Europe.7

In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Japan.8 Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

Important Safety Information
Please refer to the Minjuvi Product Information (PI) for indications, dosage and administration, precautions, and safety information in Japan, as well as the Pharmaceuticals and Medical Devices Agency (PMDA) website.

(Press release, Incyte, JUN 19, 2026, View Source [SID1234668813])

On June 19, 2026 Sanofi reported that the Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

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A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration.

In recent years, new MM diagnoses have increased steadily in Japan, creating a need for new treatment approaches particularly in the front-line setting. MM is the third most common hematologic malignancy in Japan.

"Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan," said Olivier Nataf, Global Head of Oncology at Sanofi. "This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration – with the potential to become Japan’s first anticancer therapy to be administered via an on-body injector."

The approval is based on results from the IRAKLIA phase 3 study in R/R MM (clinical study identifier: NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector for subcutaneous delivery of Sarclisa.

In the IRAKLIA study, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126; p=0.0006), in adult patients with R/R MM who had received at least one prior line of treatment. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common grade ≥3 non hematologic adverse events were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%).

In Japan, Sarclisa IV is currently approved across five indications, including in combination with VRd in NDMM, as well as four different treatment regimens in R/R MM (in combination with Pd, in combination with carfilzomib and dexamethasone (Kd), in combination with dexamethasone alone, or as a monotherapy). Sarclisa SC administered via both the CirCLIQ OBI and manual injection was approved in the EU for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in June 2026. An application for Sarclisa SC administered via both OBI and manual injection is currently under review in the US.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa plasma concentrations.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa SC is approved in the EU and the UK in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration.

Sarclisa SC is approved in Japan in combination with VRd, for the treatment of adult patients with NDMM, as well as Pd and Kd for the treatment of patients with R/R MM.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

(Press release, Sanofi, JUN 19, 2026, View Source [SID1234668814])

On June 18, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB) ("Alvotech" or the "Company"), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported the closing on June 17, 2026 of its previously announced underwritten public offering (the "Offering") of 26,066,667 of its ordinary shares at an offering price of $3.75 per share, which includes 3,400,000 ordinary shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional ordinary shares in the Offering. All ordinary shares sold in the Offering were offered by Alvotech. Before deducting the underwriting discounts and commissions and offering expenses, the aggregate gross proceeds to the Company were approximately $98 million.

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Concurrent with the Offering, Alvotech entered into Subscription Agreements with certain investors that are professional clients or eligible counterparties in the European Economic Area falling within article 1(4) of Regulation (EU) 2017/1129, pursuant to which Alvotech will issue and sell 17,826,666 ordinary shares to such investors at a price of $3.75 per ordinary share, which represents the per share public offering price, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The gross proceeds from the concurrent private placement, before deducting any transaction-related expenses, are expected to be approximately $67 million. The concurrent private placement is expected to close on or about June 25, 2026, subject to customary conditions. The consummation of the Offering was not contingent on the consummation of the concurrent private placement.

The board of directors of Alvotech has resolved to issue 43,893,333 ordinary shares to be delivered to investors participating in the Offering and the concurrent private placement and following closing of the concurrent private placement the issued share capital of Alvotech will amount to 390,431,480 ordinary shares in total.

The total gross proceeds from the Offering, including gross proceeds from the underwriters’ exercise in full of their option to purchase additional shares, and the concurrent private placement are expected to be approximately $165 million, before deducting underwriting discounts and commissions and estimated offering expenses payable.

Alvotech intends to use the net proceeds from this Offering and the concurrent private placement to fund the continued development of its biosimilar assets, as well as working capital and general corporate purposes, which may include, among others, intellectual property protection and enforcement, commercial expenditures, capital expenditures, acquisitions or collaborations, pre-clinical and clinical development of its product candidates, research and development and product development, pre-commercialization activities and repayment or refinancing of indebtedness or other corporate borrowings.

BofA Securities, Jefferies and Evercore ISI acted as joint book-running managers for the Offering.

The Offering was made pursuant to a registration statement on Form F-3, including a base prospectus, that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on October 20, 2023, and declared effective on October 30, 2023. The ordinary shares referred to in this press release were offered in the United States only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement. Copies of the final prospectus supplement and the accompanying prospectus related to this Offering may be obtained from: BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

(Press release, Alvotech, JUN 18, 2026, View Source [SID1234668809])