On April 8, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release full year 2020 results and corporate update on Thursday, April 15, 2021 (Press release, Affimed, APR 8, 2021, View Source [SID1234577741]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time.

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The conference call will be available via phone and webcast. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 4271307 approximately 15 minutes prior to the call.

To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on the Affimed website for 30 days after the call.

On April 8, 2021 Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) reported that they entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA1 (tocilizumab) (Press release, Biogen, APR 8, 2021, View Source [SID1234577726]).

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ACTEMRA’s primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. In 2020 global sales of ACTEMRA were 2.8 billion CHF.2 Biogen will gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen will expand its global biosimilars footprint with the potential approval of BAT1806.

Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they offer cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

"We are excited about this new transaction with Bio-Thera Solutions, a leading commercial-stage biopharmaceutical company in China, and how BAT1806 will augment our expanding portfolio of biosimilars assets," said Chirfi Guindo, Head of Global Product Strategy and Commercialization at Biogen. "Biosimilars deliver sustainable value for patients, physicians, healthcare systems and society by expanding access to leading biologic therapies worldwide."

"Bio-Thera Solutions is pleased to work with Biogen, one of the world’s first and leading global biotechnology companies, to commercialize BAT1806, our tocilizumab biosimilar program in all countries outside of China," said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. "This agreement allows Bio-Thera Solutions and Biogen to bring a potentially new biosimilar option to patients."

Under the terms of the agreement, Biogen will make an upfront payment of $30 million to Bio-Thera Solutions, contingent upon Bio-Thera Solutions’ Phase 3 for BAT1806 achieving satisfactory results. Should certain commercial milestones be achieved, Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.

Closing of the transaction is contingent upon completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. The transaction is expected to close in the second quarter of 2021.

On April 8, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported the official launch of BRUKINSA (zanubrutinib) in Canada for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) (Press release, BeiGene, APR 8, 2021, View Source [SID1234577742]). BRUKINSA was authorized for sale by Health Canada in this indication on March 1, 2021, following the previous grant of priority review in September 2020.

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"On behalf of the Waldenström’s Macroglobulinemia Foundation of Canada (WMFC), we are pleased to see BeiGene’s launch of BRUKINSA as a WM treatment in Canada following the approval last month. We hope this will help expand access to an important treatment option for Canadian WM patients"

In tandem with the commercial launch of BRUKINSA, the myBeiGene patient support program is available in Canada to support patients, caregivers, and healthcare providers with access to BRUKINSA.

"We are thrilled to officially launch BRUKINSA in Canada, making this potentially best-in-class BTK inhibitor available to Canadian WM patients. Since the approval in Canada five weeks ago, our team has been working to set up distribution channels across the country for a speedy launch," said Peter Brenders, General Manager of Canada at BeiGene. "Together with the myBeiGene patient support program with comprehensive financial assistance, disease education, and emotional support, we are striving to ensure access for patients in Canada."

"On behalf of the Waldenström’s Macroglobulinemia Foundation of Canada (WMFC), we are pleased to see BeiGene’s launch of BRUKINSA as a WM treatment in Canada following the approval last month. We hope this will help expand access to an important treatment option for Canadian WM patients," commented Paul Kitchen, Chair of the Board at WMFC.

The approval in Canada for BRUKINSA was based on efficacy results from the Phase 3 ASPEN clinical trial, a randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met.

The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials.

The recommended total daily dose of BRUKINSA is 320mg.

"Zanubrutinib is a newly approved treatment in Canada. We are glad to learn that this second-generation BTK inhibitor is now available for Canadian patients," said Christine Chen, M.D., Med, FRCPC, Associate Professor at the University of Toronto and Clinical Investigator at Princess Margaret Cancer Centre.

About myBeiGene Patient Support Program

The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA. It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well provide practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Nurse Advocates are available Monday through Friday from 8 a.m. to 5 p.m. Eastern Time at 1-833-234-4366.

About Waldenström’s Macroglobulinemia

Waldenström’s macroglobulinemia (WM) is a rare indolent B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin’s lymphoma (NHL). The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.1 In Canada and the United States, the incidence rate of WM is about five cases per million people per year.2

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); and
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021).
In Canada, a new drug submission for BRUKINSA for the treatment of patients with MCL who have received at least one prior therapy has been accepted and is currently under review. Currently, more than 20 marketing applications for BRUKINSA have been submitted, covering more than 40 countries and regions globally, including the United States, China, and European Union.

On April 8, 2021 Ryvu Therapeutics (WSE:RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States (Press release, Ryvu Therapeutics, APR 8, 2021, View Source [SID1234577759]). Patients who are currently taking RVU120 may continue treatment in the study. No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.

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Ryvu received the clinical hold letter from the FDA on April 8th and plans to work diligently with the agency to address the comments and request, in order to resolve the partial clinical hold.

The partial clinical hold was initiated following Ryvu’s recent report to the FDA of a Serious Adverse Event involving a patient death that may possibly be related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis. The other patient in the same study cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.

"Patient safety is Ryvu’s priority," said Pawel Przewiezlikowski, CEO of Ryvu. "Based on the totality of the data we have for RVU120, we believe that it continues to be a promising treatment option for cancer patients, and we will continue to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. We remain on track to present detailed interim safety and efficacy data at upcoming scientific conferences."

Ryvu will host a conference call to discuss today’s announcement for addressing investor’s questions, on Friday, April 9th 2021, at 8:00am CET. The conference will be open for everyone to participate: View Source

On April 8, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the issuance of US$100 million of shares at a price equivalent to US$30.5 per American Depositary Share ("ADS") via a private placement to funds affiliated with Baring Private Equity Asia ("BPEA") (Press release, Hutchison China MediTech, APR 8, 2021, View Source [SID1234577711]).

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Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We expect significant growth of our business this year as we look to accelerate our oncology revenues from ELUNATE, SULANDA and the potential upcoming approval of savolitinib, likely to be a first-in-class selective c-MET inhibitor in China. We are rapidly expanding global development of our ten oncology assets, all of which were discovered in-house at HUTCHMED, and are planning to initiate 8-10 registration and registration-intent studies in 2021. This is the right time to welcome BPEA to our existing shareholder base, a firm with a long history of supporting innovative globally-focused businesses. We look forward to partnering with BPEA in the next stage of our development."

Mr. Jean Eric Salata, Chief Executive Officer and Founding Partner of BPEA, said, "With this strategic investment, BPEA is demonstrating our long-term commitment to HUTCHMED, an emerging biopharma leader in Asia. The healthcare sector in China is a core area of investment focus for BPEA. HUTCHMED is developing and delivering highly differentiated oncology therapies to patients around the world and we look forward to working with the CEO and management team to support the company’s innovation and global growth aspirations".

Founded in 1997, BPEA is one of the largest and most established independent private equity firms in Asia with approximately $23 billion of assets under management. BPEA has a well-established track record investing in the healthcare sector with a diverse portfolio across different verticals, providing strategic capital to and working closely with industry leaders to grow their businesses over the long-term.

HUTCHMED will receive all proceeds from this private placement of the equivalent of 3,278,689 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

HUTCHMED has agreed to issue 16,393,445 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by BPEA. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. BST on April 14, 2021.

Following admission of the Shares to trading on AIM, the issued share capital of HUTCHMED will consist of 744,515,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 744,515,660 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 744,515,660 ordinary shares were converted in their entirety, they would be equivalent to 148,903,132 Nasdaq-traded ADSs (each equating to five ordinary shares).