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BASEL, Switzerland & CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--BeiGene (NASDAQ: BGNE; HKEX: 06160) announced today that the European Commission (EC) approved BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenstrms macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible.

BTK inhibition is an established mode of treatment for patients with WM, and the approval of BRUKINSA provides an important new option for patients with WM that may offer improved outcomes, said Prof. Christian Buske, Medical Director at the University Hospital Ulm, Germany, and a trial investigator of the ASPEN study. Patients and their physicians in the EU will soon have access to an innovative medicine that has potential to offer deep and durable responses and improved tolerability, as seen in the ASPEN trial.

The EC approval for BRUKINSA follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the results of the ASPEN trial. Although the primary endpoint of statistical superiority related to deep response, very good partial response (VGPR) or better, was not met, BRUKINSA demonstrated clinical benefit with advantages in safety compared to ibrutinib.1 Read more about the positive CHMP opinion and ASPEN trial results here.

With BRUKINSA now approved in the EU, we continue to execute on our commitment of making this potentially best-in-class BTK inhibitor available for more patients around the world who may benefit, said Jane Huang, M.D., Chief Medical Officer, Haematology at BeiGene. BRUKINSA was designed to maximize BTK occupancy and minimize off-target effects and has demonstrated efficacy and advantages in safety and tolerability over ibrutinib in the ASPEN trial. We believe BRUKINSA will become the preferred treatment option among patients with WM and their physicians.

We have built a strong team in Europe that is committed to creating access to BRUKINSA for patients living with WM, said Gerwin Winter, Senior Vice President, Head of Commercial, Europe at BeiGene. This approval by the European Commission is a significant milestone for BeiGenes expansion in the region, representing another step towards BeiGenes goal of increasing access to innovative oncology medicines globally.

About Waldenstrms Macroglobulinemia

Waldenstrms macroglobulinemia (WM) is a generally indolent and relatively rare B-cell malignancy characterized by bone marrow infiltration with monoclonal immunoglobulin M (IgM) secreting lymphoplasmacytic cells. WM represents approximately one percent of all non-Hodgkins lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately seven out of every one million men and four out of every one million women.4

About the ASPEN trial

The Phase 3 randomized, open-label, multicentre ASPEN clinical trial (NCT03053440) evaluated BRUKINSA (zanubrutinib) versus ibrutinib in patients with relapsed or refractory (R/R) WM or treatment-nave (TN) WM considered unsuitable for treatment with chemoimmunotherapy. The primary objective was to establish superiority of BRUKINSA compared to ibrutinib as demonstrated by the proportion of patients achieving complete response or very good partial response. Secondary endpoints included major response rate (MRR), duration of response (DoR) and progression-free survival (PFS), and safety, measured by incidence, timing and severity of treatment-emergent adverse events. The pre-specified analysis populations for the trial included the overall population (n=201), of which the majority were R/R patients (n=164). Exploratory endpoints included quality of life measures.

As assessed by an independent review committee (IRC) based on the modified Sixth International Workshop on Waldenstrms Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the combined rate of complete response (CR) and VGPR in the overall intention-to-treat (ITT) population was 28% with BRUKINSA (95% CI: 20, 38), compared to 19% with ibrutinib (95% CI: 12, 28). While this difference was not statistically significant, BRUKINSA did achieve numerically higher VGPR rates and trends towards increased response quality.1

In the ASPEN trial, BRUKINSA demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of adverse reactions that have raised concern with BTK inhibitors, including atrial fibrillation or flutter (2% vs. 15%), minor bleeding (49% vs. 59%) and major hemorrhage (6% vs. 9%). Despite higher rates of grade 3 neutropenia, patients on BRUKINSA did not demonstrate higher rates of infection as compared to those receiving ibrutinib. Of the 101 patients with WM treated with BRUKINSA, 4% of patients discontinued due to adverse events, and adverse events leading to dose reduction occurred in 14% of patients.1

The study includes three arms in two cohorts, a randomized cohort (Cohort 1, N=201) consisting of patients with a MYD88 mutation (MYD88MUT) and a non-randomized cohort (Cohort 2, N=28) in which patients with MYD88 wild-type (MYD88WT) received BRUKINSA because historic data indicated they were unlikely to benefit from ibrutinib. The randomized Cohort 1 enrolled 102 patients (including 83 R/R patients and 19 TN patients) in the BRUKINSA arm and 99 patients (including 81 R/R patients and 18 TN patients) in the ibrutinib arm. Patients in the BRUKINSA arm were assigned to receive BRUKINSA 160 mg twice daily (BID) and patients in the ibrutinib arm received 420 mg of ibrutinib once daily (QD).

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Brutons tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is now approved in the United States, China, the European Union and nine other countries and regions. To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.

Safety Information

The most commonly occurring adverse reactions (20%) were neutropenia (56.2%), thrombocytopenia (45.1%), upper respiratory tract infection (44.3%), hemorrhage/hematoma (32.2%), rash (29.8%), bruising (29.1%), anemia (28.9%), musculoskeletal pain (24.3%), diarrhea (23.6%), pneumonia (22.1%) and cough (21.7%).

The most common Grade 3 or higher adverse reactions (>5%) were neutropenia (28.0%), pneumonia (11.6%), thrombocytopenia (11.4%), and anemia (6.9%).

Of the 779 patients treated with zanubrutinib, 3.6% of patients discontinued treatment due to adverse reactions. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (1.8%). Adverse reaction leading to dose reduction occurred in 4.9% of patients.

The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily (four 80 mg capsules) or divided into two doses of 160 mg twice daily (two 80 mg capsules).

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 90 ongoing or planned clinical trials involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Haematology-oncology and solid tumour targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,700 colleagues across five continents. To learn more about BeiGene, please visit http://www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the planned commercialization and market access of BRUKINSA in the European Union and additional development, regulatory filings and potential approvals in other markets, the potential for BRUKINSA to be a best-in-class BTK inhibitor, the potential for BRUKINSA to provide improved clinical benefits with advantages in safety, the potential for BRUKINSA to become the preferred treatment option among patients with WM and their physicians, the potential commercial opportunity for BRUKINSA, and BeiGenes plans, commitments, aspirations and goals under the headings BeiGene Oncology and About BeiGene. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

* BRUKINSA is approved in the following indications and regions:

a. This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

b. This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

References:

1. Tam, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrm macroglobulinemia: the ASPEN study. Blood. October 2020. 136(18): 2038-2050.

2. Lymphoma Research Foundation. Getting the Facts: Waldenstrm Macroglobulinemia. Available at https://lymphoma.org/wp-content/uploads/2020/09/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf. Updated 2020.

3. Lymphoma Research Foundation. Available at https://lymphoma.org/aboutlymphoma/nhl/wm/. Accessed December 2020.

4. Buske, C, et al. Treatment and outcome patterns in European patients with Waldenstrms macroglobulinaemia: a large, observational, retrospective chart review. The Lancet Haematology 2018; 5: e0299-309.

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BeiGene Announces Approval of BRUKINSA (zanubrutinib) in the European Union for Treatment of Adults with Waldenstrm's Macroglobulinemia - Business...

Operators may request a binding information decision from the relevant customs authorities in the EU, in order to obtain certainty about the application of customs legislation in respect of the tariff classification or the origin of imported goods across the EU. Currently, EU customs legislation does not facilitate the issuing of a binding information decision in respect the value of imported goods. This can present real challenges for importers where customs authorities across the EU adopt differing approaches on customs valuation matters, which is not uncommon, particularly for the most complex valuation matters (e.g. treatment of royalties/licence fees, assists, transfer pricing adjustments, etc.).

The EU now has announced plans to include binding valuation information (BVI) decisions in its customs legislation. The aim is that this will increase transparency and legal certainty, and to support compliance and consistency in the treatment of EU customs valuation matters across the EU. This should also bring the EU in line with international standards for advanced customs rulings.

The move follows the conclusion of the public consultation in 2018 which assessed interest in creating a legal basis for BVI decisions and the potential scope for BVI decisions. The EU is currently drafting the implementing regulation and it is anticipated that the European Commission will adopt the implementing regulation in the second quarter of 2022.

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European Union: The EU to Introduce Binding Valuation Decisions - GlobalComplianceNews

The latest epidemiological map issued by the European Centre for for Disease Prevention and Control(ECDC)captures the increase of cases across the European Union and the European Economic Area, as almost its entirety now consists of red and deep red zones.

Cyprus remains in the red category for another week.

The ECDC map does not record the number of deaths or hospitalisation, or the levels of vaccination, but only the number of new cases per 100 thousand people over the past 14 days.

After the rapid rise in cases over the past few weeks, only some areas in France, Spain and Sweden, as well as Malta and most areas in Italy, remain in the orange zone.

Meanwhile, the deep red category now includes Greece, Croatia, Slovenia, Austria, Hungary, Czechia, Slovakia, Belgium, the Netherlands, Denmark, Estonia, Latvia, Lithuania, the Republic of Ireland and Iceland.

Only two regions in Poland remain in the red category, with the situation worsening in the rest of the country.

Southern and eastern Germany remains in the deep red zone, while its north-western areas remain in the red category.

The red zone includes Cyprus, Romania (where there has been a slight improvement compared to last week), Bulgaria (where the epidemiological situation is also improved), Portugal, Finland and Norway (where some areas are in the deep red category).

France, Spain and Sweden are also mostly in the red category.

Orange zone areas are defined as the areas where the 14-day cumulative COVID-19 case notification rate is below 50 and the test positivity rate of tests for COVID-19 infection is 4% or more, or the 14-day cumulative COVID-19 case notification rate is between 50 and 75 and the test positivity rate is 1% or more, or the 14-day cumulative COVID-19 case notification rate is between 75 and 200 and the test positivity rate is lower than 4%.

Red zone areas are defined as the areas where the 14-day cumulative COVID-19 case notification rate ranges from 75 to 200 and the test positivity rate of tests for COVID-19 infection is 4% or more, or the 14-day cumulative COVID-19 case notification rate is more than 200 but less than 500 (when the cumulative rate exceeds 500 the area enters the deep red zone).

ECDC publishes relevant maps and data every Thursday, in support of the Council recommendation on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic. The maps are based on data reported by the Member States to the European Surveillance System (TESSy) by midnight on Tuesday.

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ECDC epidemiological map shows almost the entirety of the European Union in the red or dark red zone - in-cyprus

BRUSSELS (AP) Fears that the authoritarian leader of Belarus is using migrants and refugees as a hybrid warfare tactic to undermine the security of the European Union are putting new strains on some of the values and laws in the 27-nation bloc.

The crisis at the eastern frontiers of Poland, Lithuania and Latvia is fueling calls for the EU to finance the construction of something it never wanted to build: fences and walls at the border.

And this idea was voiced this week at a ceremony commemorating the fall of one of Europes most notorious and historic barriers, the Berlin Wall.

The border crisis with Belarus has been simmering for months. Top EU officials say the longtime authoritarian leader of Belarus, President Alexander Lukashenko, is luring thousands of migrants and refugees to Minsk with the promise of help to get to western Europe.

Belarus denies it is using them as pawns, but the EU maintains Lukashenko is retaliating for sanctions it imposed on his regime after the presidents disputed election to a sixth term last year led to antigovernment protests and a crackdown on internal dissent.

The crisis came to a head after large groups of asylum-seekers recently gathered at a border crossing with Belarus near the village of Kuznica, Poland. Warsaw bolstered security there, sending in riot police to turn back those who tried to cut through a razor-wire fence.

Polish lawmakers introduced a state of emergency and changed the countrys asylum laws. Only troops have access to the area, to the dismay of refugee agencies and Polands EU partners. Lithuania is taking similar measures and has begun extending its border fence.

The EUs executive branch, the European Commission, believes walls and barriers are ineffective, and has so far resisted calls to fund them, although it will pay for infrastructure like surveillance cameras and equipment.

In the heightened security climate, that attitude may be changing.

We are facing a brutal, hybrid attack on our EU borders. Belarus is weaponizing migrants distress in a cynical and shocking way, European Council President Charles Michel said at an event in Germany on Tuesday, the 32nd anniversary of the fall of the Berlin Wall.

We have opened the debate on the EU financing of physical border infrastructure. This must be settled rapidly because Polish and Baltic borders are EU borders. One for all and all for one, Michel said.

That approach, and other border tactics, are sowing dismay. Addressing EU lawmakers Wednesday, U.N. High Commissioner for Refugees Filippo Grandi called for European leadership and appealed to the bloc to avoid a race to the bottom on migration policy.

These challenges simply do not justify the knee-jerk reaction we have seen in some places: the irresponsible xenophobic discourse; the walls and barbed wire; the violent pushbacks that include the beating of refugees and migrants, sometimes stripping them naked and dumping them in rivers, or leaving them to drown in seas; the attempts to evade asylum obligations by paying other states to take on ones own responsibilities, Grandi said.

The European Union, a union based on rule of law, should and can do better, he said.

About 8,000 migrants have entered from Belarus this year, and border guards have prevented about 28,000 attempted crossings, according to European Commission figures.

Monique Pariat, a senior commission home affairs official, said most are Iraqis or Syrians, flying to Minsk from Lebanon, Jordan, Turkey, Syria and the United Arab Emirates. They pay a lot of money to a state-owned tourist company, which goes into Lukashenkos pockets, she said.

Its the last thing Europeans want to see. The entry in 2015 of well over 1 million people, most fleeing conflict in the Middle East, sparked the EUs most intractable political crisis. They are unable to agree on who should take responsibility for refugees and migrants and whether other EU countries should be obliged to help.

Greece and Italy were on the front line six years ago. Spain has received thousands of asylum-seekers in recent years. Now, its the turn of Poland, Lithuania and Latvia.

Many in the West believe that Russian President Vladimir Putin supports Lukashenko in targeting Europe.

They know very well that this is a subject that divides European Union member states. We must be very aware that it would be playing their game to bicker among ourselves, Isabel Wiseler-Lima, a conservative EU lawmaker from Luxembourg, said.

At a summit late last month, leaders of the bloc ordered the commission to propose any necessary changes to the EUs legal framework and concrete measures underpinned by adequate financial support to ensure an immediate and appropriate response.

A few weeks earlier, 12 member countries - Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Slovakia - had demanded that the European Commission bolster the rules governing Europes passport-free travel zone, known as the Schengen area.

They want stronger border protection and new tools to avoid the grave consequences of overburdened migration and asylum systems and exhausted accommodation capacities that might hurt public trust in the EUs ability to act decisively.

The question is whether these tools would constitute pushbacks - the denial of entry to people, often by force, without affording them any opportunity to apply for asylum which are illegal under international refugee treaties and EU law.

EU officials and U.N. agencies already worry that Poland is denying access to its border area near Belarus, where thousands have been refused entry in circumstances that cannot be independently verified. Eight people have died in the border no mans land.

The commission is also examining recent changes to Polish law on the right to asylum, which seems in this case not to be assured, spokesman Adalbert Jahnz said.

As tensions mount, security is tightening and old methods are again gaining favor.

Europe must protect its external borders, and time has proven that the only effective solution is physical barriers to secure European citizens against the mass arrival of illegal migrants, Hungarian Prime Minister Viktor Orban wrote in a letter to the commission last week, seeking reimbursement for funds his government spent on its own border fences.

___

Follow APs global migration coverage at https://apnews.com/hub/migration

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EU values, laws under threat amid standoff at Belarus border - Associated Press

One year ago, on 8 November 2020, the people of Myanmar cast their ballots in large numbers in the countrys general elections. Their choice was clear and their aspirations for democracy explicit. The elections were an important milestone in Myanmars democratic transition and were confirmed as transparent by all independent domestic and international observers. The military coup on 1 February 2021 forcibly overthrew the civilian government in blatant violation of the will of the people, with disastrous humanitarian, social, economic and human rights consequences. The announcement to extend the state of emergency until August 2023 under the guise of a caretaker government can in no way grant legitimacy to the military regime. The European Union strongly condemns the grave human rights violations by the Myanmar armed forces since then.

The current military build-up in the central and northwestern part of the country, including the Sagaing and Magway regions, and the resulting escalation of violence particularly in Chin State, are of deep concern. The European Union condemns in the strongest terms the attacks by the Myanmar military on civilians and villages in Chin State, including the use of torture, sexual violence, arbitrary detention and the destruction of private property and religious sites, which are blatant violations of human rights and international law and call for justice and accountability. The European Union reiterates its calls for an immediate cessation of all hostilities and the disproportionate use of force witnessed in recent days. The military authorities must ensure rapid, safe and unhindered humanitarian access to all displaced persons and people in need, in all parts of the country. The European Union will continue to provide humanitarian assistance, in accordance with the principles of humanity, neutrality, impartiality and independence and is deeply concerned by the combined effects of the conflict, food insecurity and COVID-19 on the population.

The escalation of violence led by the Myanmar armed forces also runs counter to the commitments made at the ASEAN Leaders Summit in April, setting out the Five Point Consensus. The European Union continues to call for its immediate and full implementation. The European Union further calls for the immediate and unconditional release of all those arbitrarily detained in connection with the coup, including President Win Myint and State Counsellor Aung San Suu Kyi.

The European Union welcomes the appointment of Noeleen Heyzer as the Special Envoy of the Secretary General of the United Nations on Myanmar and welcomes continued close collaboration with the United Nations. The European Union also reiterates its full support for the approach and efforts of ASEAN and the ASEAN Chairs Special Envoy, Erywan Yusof, Foreign Minister II of Brunei Darussalam, to engage in a meaningful and inclusive process of dialogue involving all relevant parties in the country, including the National Unity Government and the Committee Representing Pyidaungsu Hluttaw. The European Union underlines that a meaningful political dialogue must include full, equal and meaningful participation of women, youth and ethnic groups.

The European Union welcomes the actions taken by ASEAN in view of its recent summit. The European Union looks forward to engaging closely with Cambodia as the Chair of ASEAN for 2022 and as the chair of the Asia-Europe Meeting (ASEM) on 24-26 November 2021. The European Union will continue to support ASEANs efforts to ensure a peaceful resolution of the current crisis that will ensure the countrys swift return to a democratic path.

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Myanmar/Burma: Declaration by the High Representative on behalf of the European Union - EU News