On December 3, 2021 Henlius Biotech (Fosun) reported that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA) (Press release, Shanghai Henlius Biotech, DEC 3, 2021, View Source [SID1234605560]). It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Hanbeitai is the company’s fourth monoclonal antibody (mAb) approved in China, following rituximab biosimilar Hanlikang, trastuzumab biosimilar Hanquyou (ZercepacⓇ in the EU), and adalimumab biosimilar Handayuan. The pipeline has been further replenished with widened indication coverage including hematological malignancies, solid tumors, auto-immune diseases, etc.

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Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "We are excited to have Hanbeitai get approved as our fourth product. The credit goes to all the healthcare professionals, patients and regulatory authorities that have contributed to the studies of Hanbeitai. While maximizing the value of biosimilar drugs, we will continue advancing the clinical trial process of its combination with in-house immunotherapy products, such as serplulimab, and growing into a more innovative global biopharmaceutical company."

Mr. Jason Zhu, President of Henlius, said, "Lung cancer and colorectal cancer are ranked second and third with high incidence of cancers in the world, respectively. They are also ranked first and second in China, and there is a huge demand for treatment. The similarity studies showed no statistically significant difference in efficacy, and the safety are highly similar to the originator. It is believed that the approval of Hanbeitai will further improve the accessibility of bevacizumab and provide a high-quality option for patients with lung cancer and colorectal cancer."

Study showed Hanbeitai is highly similar to the originator, addressing significant unmet clinical needs

Hanbeitai was developed in accordance with the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative), and has received support from National Science and Technology Major Project in the 12th & 13th Five-Year Plans of China-Major New Drug Research & Development Project. The approval is mainly supported by a series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies, comparative clinical studies. Different from approved bevacizumab biosimilars in China, the Phase 3 study of Hanbeitai was conducted among Chinese patients with metastatic colorectal cancer (CRC), which helps to accumulate more clinical evidence and experience of bevacizumab in this patient population. The relevant Phase 3 clinical studies were published at the 23rd annual conference of Chinese Society of Clinical Oncology (CSCO) for the first time and awarded an "outstanding study paper". And then the Phase 3 results were published on the world-renowned journal BioDrugs. The Phase 1 clinical study results were also published on Cancer Chemotherapy and Pharmacology.

According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally and accounts for 11.4% of the global cancer incidence in 2020. It is estimated that 810,000 people are diagnosed with LC in China, and LC is the first leading cause of cancer incidence and mortality. NSCLC is the most common type of LC, accounting for 80%-85%. The incidence rate of CRC ranks second among all malignant tumours in China, with over 550,000 new cases in 2020. Clinical studies showed that adding bevacizumab to traditional chemotherapies can significantly delay disease progression and prolong survival for patients with mCRC and is one of the standards of care for advanced CRC.

By specific binding with vascular endothelial growth factor (VEGF), Hanbeitai can block the interaction between VEGF and its receptors. This will inhibit tumour angiogenesis, which is essential for the growth and metastases of tumour. The originator has been approved for CRC, LC, glioblastoma, hepatocellular carcinoma (HCC), ovarian cancer, cervical cancer in China. For global the indications also include renal cell carcinoma and breast cancer, and so on. However, there are still significant unmet needs due to drug accessibility in China. Going beyond, Henlius will explore more indications to benefit more patients.

Exploring more therapies

Building upon the advantages in the field of broad-spectrum anti-tumour of bevacizumab, Henlius is actively developing combo therapies of Hanbeitai and its anti-PD-1 mAb serplulimab for the treatment of various solid tumours. Clinical studies of this combo have been conducted in first-line nsNSCLC and first-line CRC. The first-line nsNSCLC study has entered the pivotal Phase 3 stage. The CRC Phase 2 clinical trial is on track. With the continuous exploration, Henlius aims to benefit patients with immuno-oncology mAbs combination therapies as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC.

According to the requirements of ophthalmic drugs, Henlius is also developing a new ophthalmic preparation product, HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection), based on Hanbeitai, through optimizing the prescription, specifications and production processes of Hanbeitai, with active ingredients remaining unchanged. It is intended to be used for the treatment of wet age-related macular degeneration (wAMD). In the first half of 2021, HLX04-O has been approved to carry out Phase 3 clinical trials in Australia, the United States, Singapore, and EU countries such as Latvia, Hungary and Spain. In addition, the first patient was dosed in a HLX04-O Phase 3 clinical trial in China for the treatment of wAMD.

Looking forward, with its core values of "Affordable Innovation, Reliable Quality", Henlius is actively accelerating the R&D and commercialisation of more biologics and enriching innovative target layouts. What’s more, the company will continue developing a forward-looking presence in bispecific antibodies and antibody-drug conjugates (ADC), and bringing more high-quality and affordable therapies to patients worldwide.

On 3 December 2021 Recordati announces the signing of a share purchase agreement to acquire EUSA Pharma (UK) Ltd, a global specialty pharmaceutical company with headquarters in the United Kingdom, focused on rare and niche oncology diseases and controlled by funds managed by EW Healthcare Partners (Press release, Recordati, DEC 3, 2021, View Source [SID1234652186]).

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Recordati is acquiring EUSA Pharma for an enterprise value of €750 million; the payment of the consideration will be funded via existing liquidity and bridge financing fully underwritten by J.P. Morgan and Mediobanca.

EUSA Pharma was founded in March 2015 and has grown rapidly into a world-class pharmaceutical company with a portfolio of 4 rare and niche oncology products with approximately €130 million LTM(1) Net Sales at 30 June 2021 and Net Debt of around €26 million at that same date. The company has extensive commercial operations in the EMEA and United States, alongside a presence in other international markets. The company employs more than 200 people with strong patient centric culture and deep disease area expertise. EUSA Pharma’s products include: Qarziba, an anti-GD2 monoclonal antibody indicated for high-risk neuroblastoma approved in Europe and other countries, and with potential for expansion in the US; Sylvant, an anti-IL-6 monoclonal antibody, the first and only ever approved treatment for Idiopathic Multicentric Castleman’s disease (iMCD) in US and in Europe, marketed also in other countries and well positioned in a market with limited options for patients; Fotivda, an oral highly selective small molecule tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor (VEGF) receptors 1,2 and 3, approved for first-line treatment of advanced renal cell carcinoma in Europe and other countries; Caphosol , a medical device for oral mucositis due to chemo and radio therapy, approved in US, EU and other markets. The transaction would provide Recordati with an expanded portfolio of rare disease pharmaceutical products which is expected to contribute in 2023 revenue of over €150 million and EBITDA(2) of approximately €50 million. Non-recurring costs in 2022-2023 from on-going manufacturing technology transfer and acquisition and integration related expenses are estimated to be approximately €35 million (subject to timing of close).

On December 3, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) reported that, following the 2021 negotiations with the China National Healthcare Security Administration ("NHSA"), on January 1, 2022 the updated National Reimbursement Drug List ("NRDL") will continue to include ELUNATE (fruquintinib) and will now include SULANDA (surufatinib) (Press release, Hutchison China MediTech, DEC 3, 2021, View Source [SID1234596427]).

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Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We welcome the addition of SULANDA into the NRDL, along with the renewal of ELUNATE. The NRDL has made it possible for novel therapies to gain wide reach across the country for diseases with large patient populations."

ELUNATE was first included in the NRDL on January 1, 2020, for the treatment of metastatic colorectal cancer ("CRC"). CRC was the third most diagnosed form of cancer by incidence in China in 2020, with an estimated 450,000 to 550,000 new cases each year[1].

SULANDA was approved in China for the treatment of advanced non-pancreatic neuroendocrine tumors ("NETs") in December 2020 and for advanced pancreatic NETs in June 2021. In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.[2]

HUTCHMED’s third oncology drug, ORPATHYS (savolitinib), is the first and only approved MET inhibitor in China for the treatment of patients with non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations. It was also included in the 2021 negotiations with the NHSA, however HUTCHMED and AstraZeneca, its partner on ORPATHYS, declined inclusion in the NRDL for 2022. This position will be reassessed next year ahead of the next NRDL update. In China, there are an estimated 13,000 newly diagnosed NSCLC patients with MET exon 14 skipping alterations each year.1

About the NRDL
In recent years, the government in China has placed great importance on improving the public affordability of drug use. The NHSA regularly convenes a broad network of experts in medicine, pharmacology and pharmaco­economics to identify innovative drugs to be considered for inclusion in the NRDL. This has led to expansion of reimbursement of Category B drugs, which increasingly include novel oncology drugs. Reimburse­ment of Category B drugs requires varying degrees of copayment from patients, depending on their province of residence or type of NHSA insurance scheme enrollment. Agreements for all included drugs are generally renewed every two years.

In this latest update of the NRDL, the NHSA is adding or renewing over 30 Category B oncology drugs, including ELUNATE and SULANDA. Effective January 1, 2022, included NRDL drugs are expected to be made available in all state-run hospital pharmacies in China and reimbursement will commence for patients included in NHSA insurance schemes.

About fruquintinib (ELUNATE in China)
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors ("VEGFRs") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib is marketed in China under the brand name ELUNATE for the treatment of metastatic CRC. It is currently under clinical development for the treatment of gastric cancer and metastatic breast cancer, and in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.) and sintilimab (TYVYT in China, IBI308, developed by Innovent Biologics, Inc.). The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation for the development of fruquintinib for treating metastatic CRC in June 2020. A Phase III registration study of fruquintinib in metastatic CRC, FRESCO-2, is currently underway in the U.S., Europe, Japan and Australia.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company. Since October 2021, HUTCHMED has been responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About surufatinib (SULANDA in China)
Surufatinib is a novel, oral inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Surufatinib is marketed in China under the brand name SULANDA for the treatment of patients with advanced NETs. It is currently under clinical development in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab and toripalimab (TUOYI, developed by Shanghai Junshi Biosciences Co., Ltd.). A U.S. FDA New Drug Application (NDA) submission was accepted in June 2021, followed by a Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA) validated in July 2021. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic NETs in April 2020, and Orphan Drug Designation for pancreatic NETs in November 2019.

HUTCHMED currently retains all rights to surufatinib worldwide.

About savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective MET inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

On December 3, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the publication of preclinical research of zunsemetinib in pancreatic cancer in the peer-reviewed journal Science Translational Medicine, on December 1, 2021 (Press release, Aclaris Therapeutics, DEC 3, 2021, View Source [SID1234596443]).

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The article, entitled "The MK2/Hsp27 axis is a major survival mechanism for pancreatic ductal adenocarcinoma under genotoxic stress," presents the results from a preclinical study using patient-derived cell lines and an autochthonous pancreatic ductal adenocarcinoma mouse model that evaluated the role of MK2, as well as the impact of zunsemetinib (ATI-450), Aclaris’ investigational oral MK2 inhibitor, in pancreatic cancer. This study was a multi-year collaboration between Aclaris and Washington University School of Medicine, led by the laboratory of Dr. Kian-Huat Lim, MD, PhD, Associate Professor in Oncology and Dr. Patrick Grierson, MD, PhD, Assistant Professor in Oncology.

In the study, Dr. Lim and his team identified the MK2/HSP27 axis as an important resistance mechanism resulting in pancreatic tumor cell survival following exposure to components of FOLFIRINOX chemotherapy – the current standard-of-care treatment for pancreatic cancer. His team also demonstrated that DNA damage induced by FOLFIRINOX chemotherapy components upregulated tumor necrosis factor alpha (TNFa) in pancreatic cancer cells, which had the dual effect of impacting cell death and cell survival, and that the selective inhibition of MK2 downstream of TNFa signaling abrogated survival through blocking HSP27 activation and beclin1 mediated autophagy, which allowed TNFa to execute its pro-death mechanism. With this understanding, his team then showed that mouse survival in an autochthonous KPPC model of pancreatic cancer was statistically significantly (p<0.001) extended when dosed with zunsemetinib in combination with FIRINOX (a murine version of FOLFIRINOX).

"This study introduces a new MK2-targeted approach for the treatment of pancreatic cancer," said Dr. Lim. "We are very excited about the potential of this therapeutic combination and believe it should be advanced into clinical trials to determine whether MK2 inhibition can strengthen the effect of mainstay FOLFIRINOX chemotherapy in patients with pancreatic cancer without incurring additional side effects."

Based on these results and clinical data generated from Aclaris’ clinical development program with zunsemetinib, Aclaris is considering a future clinical program for the treatment of patients with pancreatic cancer using one of Aclaris’ other MK2 inhibitor drug candidates.

The authors of the article are Patrick M. Grierson, Paarth B. Dodhiawala, Yi Cheng, Timothy Hung-Po Chen, Iftikhar Ali Khawar, Qing Wei, Daoxiang Zhang, Lin Li, John Herndon, Joseph B. Monahan, Marianna B. Ruzinova, and Kian-Huat Lim, and the article can be accessed here: View Source

On December 3, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in virtual investor meetings and present at The JMP Securities Hematology and Oncology Summit that will be held December 6-7, 2021 (Press release, Hookipa Biotech, DEC 3, 2021, View Source [SID1234596444]).

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Corporate Presentation: Tuesday, December 7, 2021 at 1:20 PM EST

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.