2020年8月11号

BridgeBio Pharma与Perceptive Advisors创立的联拓生物(LianBio)建立战略联盟并拓展中国及其他亚洲主要市场

BridgeBio将获得2,650万美元的短期经济权益,以及高达5.05亿美元的阶段性付款 和两位数的分层销售分成,并投资增持联拓生物股权

BridgeBio创始人及首席执行官Neil Kumar博士获任为联拓生物董事会成员

2020年8月11日 美国加利福尼亚州,帕罗奥图讯 — BridgeBio Pharma股份有限公司(纳斯达克交易代码:BBIO)是一家专注于基因疾病及由明确基因导致癌症的临床阶段生物制药公司。该公司今日宣布与Perceptive Advisors新创立的总部位于上海的联拓生物(LianBio)合作,将其管线拓展至全球第二大的医药市场——中国。此合作标志着BridgeBio对亚洲市场全面开展战略布局。

此次战略合作初期将专注于BridgeBio研发的两款肿瘤产品,包括现正进行3期临床试验的选择性FGFR抑制剂infigratinib,以及治疗因RAS和酪氨酸激酶受体导致的实体肿瘤的SHP2抑制剂BBP-398。此合作协议同时使联拓生物获得BridgeBio超过20种管线产品在中国及其他亚洲主要市场的优先使用权。此次合作旨在加速推进BridgeBio在该地区的临床研究和商业化,让BridgeBio能以创新的手段迅速解决庞大群体的医疗需求。

BridgeBio 创始人及首席执行官Neil Kumar博士表示:“在中国,我们看到了庞大的医疗需求和高速发展的医疗基础设施建设。中国市场是我们的战略重点,我们不仅期望将晚期疗法推及至更多病患,更希望通过加速推进在亚洲的临床研究,更早地了解及满足该地区患者的需求。通过与联拓生物的合作,我们很高兴能与Perceptive Advisors建立更深入的联系,开展长远合作,惠及更多患者。”

Perceptive Advisors首席投资官Adam Stone认为:“我们重视与BridgeBio的合作关系,也很高兴能助力BridgeBio的重要管线进入联拓生物的业务领域。BridgeBio及其子公司一直以来深耕基础科学研究,致力于以精准医疗驱动健康领域的创新和发展。我们期待此次合作能通过BridgeBio前景广阔的管线和联拓生物对本地市场的专业了解,加快前沿疗法的全球研发以及本土落地的速度。”

根据协议条款,联拓生物将获得中国及指定亚洲市场的商业化权益,并参与infigratinib (BridgeBio 子公司QED产品)和BBP-398(BridgeBio子公司Navire产品)的临床研发。 BridgeBio短期内的经济权益包括2,650万美元首付款和阶段性付款,长期将获得高达5.05亿美元的阶段性付款,并在许可地区售出两款药物的净销售额中,获得个位数至两位数的分层销售分成。此外,BridgeBio将投资增持联拓生物股权, BridgeBio首席执行官Neil Kumar博士同时获任联拓生物董事会成员。

联拓生物目前在中国大陆参与infigratinib 用于治疗一线胆管癌(PROOF)的3期临床试验,并计划进一步启动将infigratinib用于胃癌以及其他因FGFR基因变异导致的肿瘤疾病的2a期临床研究。此外,在中国大陆和亚洲其他主要市场,联拓生物将在各种实体肿瘤(如非小型细胞癌、结肠直肠癌和胰腺癌)中研究BBP-398与其他药物组合的联合疗法。

关于BridgeBio Pharma
BridgeBio成立于2015年,是一支拥有丰富药物研发和创新经验的专业团队。 BridgeBio致力于从源头上针对病因明确的遗传性疾病开发和推进具有革命性的药物,包括孟德尔遗传病(由单一基因缺陷引起的疾病)及具有明确遗传因素的癌症。 BridgeBio的产品管线有超过20个研发项目,包括从临床前到临床三期的各类候选产品。如需了解详细信息,请访问www.bridgebio.com

关于联拓生物(LianBio)
联拓生物(LianBio)的使命是通过与全球领先的生物制药公司达成战略合作关系,以高效的产品开发为中国和亚洲其他主要市场的患者提供优质的颠覆性治疗药物及科学疗法。通过与世界级合作伙伴在不同的治疗领域和地域进行合作,联拓生物建立了基于疾病相关性的产品管线,并通过转化机制和精准疗法来改善患者病情。如需了解详细信息,请访问www.lianbio.com

关于Perceptive Advisors
Perceptive Advisors成立于1999年,是一家专注于生命科学领域的领先投资公司,截至2020年6月30日,管理的资产超过70亿美元。自成立以来,Perceptive Advisors始终专注于发掘机遇并引导金融资源流向现代医疗最有前途的技术领域,为生命科学行业的进步提供支持。如需了解详细信息,请访问www.perceptivelife.com

关于QED Therapeutics
QED Therapeutics为BridgeBio Pharma的子公司,是一家专注于用精准药物治疗FGFR病变导致疾病的生物技术公司。该公司的主要研究候选药物是infigratinib(BGJ398),一种口服FGFR1-3选择性酪氨酸激酶抑制剂。在治疗伴FGFR2融合的化疗难治型胆管癌患者和伴FGFR3基因组变异的晚期尿路上皮癌患者时,infigratinib在总缓解率等临床指标中有效性显着。QED Therapeutics计划于2020年向美国食品药品监督管理局(FDA)提交二线及二线以上胆管癌的新药申请(NDA)。 QED Therapeutics还会在临床研究中评估infigratinib在治疗软骨发育不全(侏儒症)方面的疗效。 QED Therapeutics计划开展进一步临床试验,以评估infigratinib在治疗其他FGFR病变导致的肿瘤和罕见疾病患者中的潜力。如需了解详细信息,请访问www.qedtx.com

关于Navire Pharma
Navire Pharma是BridgeBio Pharma的子公司,目前正与MD Anderson的应用癌症科学研究所合作开发SHP2抑制剂作为治疗多种癌症的靶向疗法。公司正与患者和医生密切协作,将有效的治疗方法尽快而安全地推向市场。如需了解详细信息,请访问www.navirepharma.com

BridgeBio Pharma前瞻性声明
此新闻稿包含前瞻性声明。我们于新闻稿内所陈述的声明可能涉及非历史事实,并根据《美国1933年证券法修订版》(“证券法”)的27A小节以及《美国1934年证券交易法修订版》(“交易法”)的21E小节内容作为前瞻性考虑,多数情况下可以使用诸如“预测”、“相信”,“估计”、“预期”、“预备”、“可能”、“计划”、“项目”、“征询”、“应该”、“将会”及其他类似意义的词语。我们的前瞻性声明包含于证券法27A小节及交易法21E小节的免责条款之内,并遵循这些免责条款作出前瞻性声明。这些前胆性声明,包括与BridgeBio相关的预期里程碑款项及/或从联拓生物获得专利许可权费,仅反映我们目前正在进行的计划、意向、期望、策略或前景的看法,而以上声明是根据我们目前所得资料及假设作决定。尽管我们相信在前瞻性声明内所建议的计划、意向、期望、策略或前景为合理预测,然而我们却无法保证这些计划、意向、期望或策略最终属实。此外,前瞻性声明描述的内容有机会与实际结果出现重大落差并受各种风险,变数及假设所影响,包括但不限于临床试验成功、法定档案、批核及/或infigratinib和BBP-398在中国及亚洲其他主要市场的销售状况,以及BridgeBio Pharma提交的最新一期10-K表年报,10-Q表季报和BridgeBio Pharma其他SEC档案于“风险因素”之中列明的各项风险。再者,BridgeBio Pharma在一个竞争非常激烈和瞬息万变的环境下运营,并且会不断出现新的风险。除非相关法律有此要求,我们概不负责公开更新任何前瞻性声明,无论是否出现新资料,未来事件或其他情况下均属如此。

联络人:
Grace Rauh
BridgeBio Pharma, Inc.
Grace.rauh@bridgebio.com
(917) 232-5478

资料来源: BridgeBio Pharma, Inc.

$26.5 million total near-term payments to BridgeBio, plus participation in long-term value creation of up to $505 million in milestone payments, tiered double-digit royalty payments and an equity interest in LianBio.

BridgeBio CEO and founder Neil Kumar, Ph.D., has been appointed to LianBio’s board of directors.

PALO ALTO, CA - August 11, 2020 – BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, today announced that it is partnering with Shanghai-based LianBio, a new company founded by Perceptive Advisors, to expand its global reach into China, the second-largest pharmaceutical market in the world. The partnership marks the first major expansion of BridgeBio’s pipeline into Asian markets.

This strategic relationship will initially focus on two of BridgeBio’s targeted oncology drug candidates, FGFR inhibitor infigratinib, currently in Phase 3 development for FGFR-driven tumors and Phase 1-ready SHP2 inhibitor BBP-398, for tumors driven by RAS and receptor tyrosine kinase mutations. The agreement also provides LianBio with preferential future access in the territory to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio’s programs in China and other major Asian markets, allowing BridgeBio to quickly bring innovation to large numbers of patients with high unmet need.

“Tremendous patient need and a fast-developing healthcare infrastructure make China a strategic priority. We are eager to not only expand late-stage therapies to the broader patient population there, but also to accelerate our clinical development efforts in Asia and better understand and address the needs of patients there – early. We are grateful to be deepening our relationship with Perceptive Advisors through this agreement with LianBio and look forward to a lasting partnership focused on expanding our reach to patients,” said BridgeBio CEO and founder Neil Kumar, Ph.D.

“We value our relationship with BridgeBio and are happy to be enabling the entry of important programs to LianBio’s territories,” said Adam Stone, CIO of Perceptive Advisors. “BridgeBio and its affiliate companies exemplify the commitment to science-driven, precision medicine that we believe is a key driver to innovation in healthcare. We are excited about this opportunity to leverage their promising pipeline and LianBio’s local expertise to accelerate both global development and local access to leading edge therapeutics.”

Under the terms of the agreements, LianBio will receive commercial rights in China and selected Asian markets and participate in clinical development activities for infigratinib (housed in BridgeBio affiliate QED) and BBP-398 (housed in BridgeBio affiliate Navire). BridgeBio’s near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will receive up to $505 million in future milestone payments, tiered royalty payments from single- to double-digits on net sales of both products in licensed territories. Additionally, BridgeBio will increase its equity interest via investment in LianBio and BridgeBio CEO Neil Kumar has been appointed to the LianBio board of directors.

LianBio is participating in the ongoing Phase 3 study of infigratinib in first line cholangiocarcinoma (PROOF) in mainland China and further plans to initiate a Phase 2a study of infigratinib in gastric cancer and other FGFR-driven tumors. Additionally, LianBio will contribute to clinical development of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer (NSCLC), colorectal and pancreatic cancer, in mainland China and other major Asian markets.

About BridgeBio Pharma
BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio’s pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, please visit www.bridgebio.com.

About LianBio
LianBio’s mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and major Asian markets through partnerships that provide access to the best science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics. For more information, please visit www.lianbio.com.

About Perceptive Advisors
Founded in 1999, Perceptive Advisors is a leading life sciences focused investment firm with over $7 billion of regulatory assets under management as of June 30, 2020. Since inception, Perceptive Advisors has focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. For more information, please visit www.perceptivelife.com.

About QED Therapeutics
QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that it believes to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED intends to submit a New Drug Application (NDA) with the United States Food and Drug Administration for second and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. QED plans to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with other FGFR-driven tumor types and rare disorders. For more information, please visit www.qedtx.com.

About Navire Pharma
Navire Pharma, an affiliate of BridgeBio Pharma, and in collaboration with the Institute for Applied Cancer Science at MD Anderson, is developing inhibitors of SHP2 as targeted therapeutics for the treatment of multiple cancers. Together with patients and physicians, the company aims to bring safe, effective treatments to market as quickly as possible. For more information, please visit www.navirepharma.com.

BridgeBio Pharma Forward-Looking Statements
This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to BridgeBio’s anticipated receipt of future milestone and/or royalty payments from LianBio, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of clinical trials, regulatory filings, approvals and/or sales of infigratinib and BBP-398 in China and other major Asian markets, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and BridgeBio Pharma’s other SEC filings. Moreover, BridgeBio Pharma operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Grace Rauh
BridgeBio Pharma, Inc.
Grace.rauh@bridgebio.com
(917) 232-5478

Source: BridgeBio Pharma, Inc.

See All News