On February 20, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the TD Cowen 45th Annual Healthcare Conference on Monday, March 3, 2025, at 10:30 a.m. ET (Press release, Agios Pharmaceuticals, FEB 20, 2025, View Source [SID1234650406]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

On February 20, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported the sale of its China subsidiary to AstraZeneca for approximately $160 million (Press release, FibroGen, FEB 20, 2025, View Source [SID1234650405]).

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"Today, we announced the sale of FibroGen China to AstraZeneca, our long-time strategic partner for roxadustat in China, bolstering our company on several fronts. It strengthens our financial position, meaningfully extending our cash runway into 2027, and enables us to continue progressing the clinical development program for FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, in mCRPC," said Thane Wettig, Chief Executive Officer of FibroGen. "After a thorough evaluation of alternatives, we believe selling our China operations and repaying our term loan is in the best interest of FibroGen’s stakeholders. We are grateful for our China colleagues, and in particular Christine Chung, our Head of China Operations, for their unwavering commitment to patients and successful commercialization of roxadustat in China. Now, we turn the page to the next exciting chapter for FibroGen."

Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million, totaling approximately $160 million. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China. Following the close of the transaction, FibroGen will repay its term loan facility to investment funds managed by Morgan Stanley Tactical Value, further simplifying the Company’s capital structure. The combined transactions are expected to extend the Company’s cash runway into 2027.

Upon closing, AstraZeneca will obtain all rights to roxadustat in China. Roxadustat is the category leader in brand value share for the treatment of anemia in chronic kidney disease with a pending regulatory decision for chemotherapy-induced anemia.

FibroGen maintains its rights to roxadustat in the U.S. and in all markets not licensed to Astellas. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), a high-value indication with significant unmet medical need. The Company is planning for an FDA meeting in the second quarter of 2025 to determine the potential next steps for the development program for roxadustat in the U.S.

In addition, FibroGen continues to advance the clinical development of its lead asset, FG-3246, and its companion PET imaging agent, FG-3180, with the initiation of the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC expected in the second quarter of 2025.

BofA Securities, Inc. is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal advisor to FibroGen on this transaction.

Conference Call and Webcast Presentation
FibroGen management team will host a conference call and webcast presentation today, February 20, 2025 at 8:30 a.m. ET to discuss the sale of FibroGen China. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

On February 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval today from the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable alveolar soft part sarcoma (Press release, Chugai, FEB 20, 2025, View Source;category= [SID1234650398]). Tecentriq is the first immune checkpoint inhibitor in Japan for the treatment of this disease.

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"We are very pleased that we can offer Tecentriq as a new treatment for unresectable alveolar soft part sarcoma in adults and children over 2 years. This very rare disease, which occurs most often in the adolescents and young adults (AYA) generation, is known to have a poor prognosis with no standard treatment if it becomes unresectable. We will continue our efforts to provide information on the proper use of Tecentriq in order to contribute to the patients with unresectable alveolar soft part sarcoma," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from a phase II ALBERT study initiated by investigators in Japan including National Cancer Center Hospital and an overseas phase II clinical study conducted by the National Cancer Institute (NCI), which evaluated the efficacy and safety of Tecentriq in patients with unresectable alveolar soft part sarcoma.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

Approval Information *Newly added description
Indications: unresectable alveolar soft part sarcoma
Dosage and administrations: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. The usual dose for children over 2 years old is 15 mg/kg (weight) (max 1200 mg) atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

About the ALBERT study1
The ALBERT study is a domestic Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital in Japan to evaluate the efficacy and safety of Tecentriq in patients aged 16 years and older with unresectable alveolar soft part sarcoma. The study enrolled 20 patients to investigate safety and efficacy.

The ALBERT study is being conducted as a substudy of the MASTER KEY project, which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital.

About alveolar soft part sarcoma
Alveolar soft part sarcoma is one of the ultra-rare cancers accounting for less than 1% of soft tissue sarcomas. It is estimated to occur in 15-40 Japanese people annually. It most commonly affects the limbs, mainly the thighs, and is more common among adolescents and young adults (15-35 years old, AYA (Adolescent and Young Adult) generation). Unresectable alveolar soft part sarcoma has a poor prognosis, and no standard treatment has been established.

About Tecentriq
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 4 indications (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma).

On February 19, 2025 Orano reported exceptional 2024 results driven by Back End export contracts. Solid outlook for 2025 (Press release, Orano, FEB 19, 2025, View Source;orano-2024-annual-results.pdf?sfvrsn=90050233_6&_gl=1*183v0pa*_gcl_au*NDY0NzQ5OTM3LjE3NTE2MDU1ODk. [SID1234654232]).

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On February 19, 2025 Radiance Biopharma, Inc., ("Radiance" or the "Company"), a biotechnology company, reported that it has entered into an exclusive License agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for development and commercialization of RB-164 (SYS6005): a novel clinical stage antibody drug conjugate (ADC) targeting ROR-1 (Press release, Radiance Biopharma, FEB 19, 2025, View Source [SID1234653104]). The agreement covers exclusive commercialization rights to RB-164 in the United States of America (USA), Canada, the European Union, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, and Australia. CSPC will retain all rights to SYS6005 in the remaining global markets.

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ROR-1 is highly expressed in embryonic tissue, and a variety of hematological malignancies and solid tumors. ROR-1 expression is low in healthy adult cells but is closely related to disease progression and treatment response in cancer. This makes ROR-1 an attractive therapeutic target for anti-cancer drug development. RB-164 employs a novel Fc-silenced monoclonal antibody targeting ROR-1, site specific conjugation to deliver a homogeneous Drug-to-Antibody distribution and prevent retro-Michael elimination (high stability) which provides an improved pharmacokinetic and toxicology profile.

An Investigational New Drug (IND) application for RB-164 has been cleared by China’s regulatory agency, the National Medical Products Administration (NMPA). RB-164 is currently being investigated by CSPC in a Phase 1 dose escalation clinical trial in advanced liquid and solid tumors in China. Radiance and CSPC will work collaboratively to file an IND application with the USA Food & Drug Administration (FDA) to execute the clinical development of RB-164. Radiance will be responsible for the clinical development of RB-164 in the US and other licensed territories.

"We are excited to add RB-164, a promising clinical-stage Antibody Drug Conjugate targeting ROR-1, to our pipeline. This provides multiple shots on goal for potential therapeutic indications and strengthens Radiance’s development into a significant biopharma company," said Dr. Marc Lippman, MD, Chairman of the Board of Radiance.

Under the terms of the Exclusive License, Radiance will pay CSPC an upfront payment of $15 million, and up to $150 million in potential development and regulatory milestone payments and over $1 Billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales.

"We believe that RB-164 has the potential to be a best-in-class ADC against the clinically validated target of ROR-1 for the treatment of liquid and solid malignancies," said Robert Brooks, JD, Chief Executive Officer of Radiance. "We look forward to expand our pipeline with a novel clinical stage medicine for patients with cancer and high unmet needs."

"This collaboration with Radiance exemplifies our commitment to bringing our innovative treatments to patients worldwide. We look forward to working together in advancing this ADC as a promising treatment option to those battling cancer," said Zhang Cuilong, Chief Executive Officer of CSPC.