2021年9月23日，中國北京和加拿大不列顛哥倫比亞省列治文市
—— 四環醫藥控股集團有限公司，連同其附屬子公司和SignalChem Lifesciences公司今日聯合宣佈，四環醫藥集團旗下軒竹生物科技有限公司（簡稱“軒竹生物”）與SignalChem Lifesciences公司（簡稱“SignalChem”）就一款高活性和高選擇性的AXL靶向抑制劑SLC-391在大中華區的開發和商業化權益簽訂了合作和許可協議。
根據協議條款，軒竹生物將向SignalChem支付1300萬美元首付款。此外，SignalChem有資格獲得至多2億零8百萬美元潛在的開發、註冊和商業化里程碑付款，以及分級銷售分成。軒竹生物將獲得獨家的SLC-391在大中華區（中國內地、香港、澳門和臺灣地區），腫瘤治療領域各項適應症的研究、開發、生產及商業化權利。
AXL是酪氨酸蛋白激酶TAM家族 （Tyro3、AXL 和 Mer） 的成員，它與其配體GAS6（growth arrest-specific gene 6）在許多惡性腫瘤中都有高表達和活化，如急性髓系白血病、腎癌、胰腺癌、乳腺癌、肺癌及卵巢癌等等。GAS6-AXL訊號通路作為促進腫瘤生長及轉移、腫瘤免疫逃逸與藥物耐受的關鍵通路之一，被認為是癌症治療的新靶點並引起廣泛關注。
軒竹生物董事長徐豔君女士在簽約成功後表示：“此次和SignalChem的合作將進一步開拓和完善軒竹在實體瘤和血液瘤的管線佈局。臨床前和臨床1期的結果顯示SLC-391不僅在多個實體瘤和血液瘤的試驗中有單藥藥效，並可潛在與多款軒竹管線中的在研的藥物實現聯合用藥，治療一些難治性腫瘤。雙方將利用各自資源優勢，加快推進SLC-391在中國獲批。軒竹將持續致力於在腫瘤領域中創新藥的開發和商業化。”
“四環醫藥旗下的軒竹生物是一家極具創新性和進取性的公司，我們很高興與軒竹建立起合作伙伴關係。” SignalChem董事長兼總裁嚴俊先生表示。“該許可協議的簽署對於SignalChem進一步驗證和擴大SLC-391的臨床優勢具有重要意義。該協議將加快 SLC-391 進入市場的開發時間表，併為癌症患者提供更有效的治療選擇。” 嚴俊先生補充說：“與軒竹的協議規模，包括首付、里程碑付款和銷售分成，可能是加拿大與中國生物製藥公司就大中華地區權益簽署的最大協議之一，我們期待能達到所有的預期目標。此外，SignalChem 將繼續努力擴大和加速 SLC-391在世界其它區域的臨床開發，以獲得更廣泛的市場和適應症。”
# 關於SLC-391 #
SLC-391是一種有效的、高選擇性的、可口服的小分子AXL抑制劑，目前研究資料提示其為Best-in-Class， 潛在可成為“First-in-Class”。目前正在加拿大進行I期臨床研究。早前SignalChem已與默沙東（MSD）達成合作，雙方聯合開展評估SLC-391與Keytruda®（pembrolizumab）聯合用藥用於治療晚期非小細胞肺癌的有效性。臨床前研究資料表明，SLC-391化合物在不同動物模型包括NSCLC、結腸癌、CML和AML模型中均有良好的療效。在不同的模型中，已顯示出與其它已批准療法的治療協同作用。
SLC-391治療非小細胞肺癌及血液瘤的前景
肺癌是我國第二大高發的癌症型別，其中非小細胞肺癌（Non-small cell lung cancer， NSCLC）是最常見的肺癌型別，佔所有確診肺癌病例的84%，5年總體生存率非常低，僅為24%，包括區域性非小細胞肺癌的61%到轉移性非小細胞肺癌的6%不等。急性髓系白血病（acute myeloid leukemia，AML）是一種高臨床複發率的難治性髓系造血幹/祖細胞惡性疾病，屬於最常見但也最為致命的白血病型別之一。根據美國癌症協會（American Cancer Society， ACS）的統計資料表明，2020年美國共有約60，530例新發白血病病例和23，100例白血病死亡病例，其中AML新發病例約佔19，940例，並約有11，180人死於 AML。在中國，隨著靶向藥如BCL2抑制劑維蘭托克2020年的獲批上市，為不能耐受強誘導化療的患者帶來了新的治療選擇。SLC-391在臨床聯合用藥治療上述疾病方面具有巨大市場潛力。
Xuanzhu and SignalChem Lifesciences Corporation Announce Collaboration and Licensing Agreement for SLC-391 in the Greater China Region
September 23， 2021， Beijing， China and Richmond， British Columbia， Canada —— Sihuan Pharmaceutical Holdings Group Ltd。， together with its subsidiaries and SignalChem Lifesciences Corporation today announced that Sihuan Pharmaceutical Holdings Group Ltd subsidiary company Xuanzhu Biopharmaceutical Co。， Ltd。 （“Xuanzhu”） and SignalChem Lifesciences Corporation （“SignalChem”） have entered into an exclusive collaboration and licensing agreement for the clinical development and commercialization of SLC-391， a potent and selective AXL targeting inhibitor， in the Greater China region。
Under the terms of the agreement， Xuanzhu will pay to SignalChem an upfront fee of thirteen million US dollars （US$13，000，000）。 Additional development milestones and royalties have also been committed。 The exclusive rights for SLC-391 for the field of oncology is for the Greater China region （Mainland China， Hong Kong， Macau and Taiwan）。
AXL is a member of TAM （Tyro3， AXL， Mer） family of receptor tyrosine kinases。 AXL along with its ligand GAS6 （growth arrest-specific gene 6） is highly expressed and activated in many malignant tumors， such as acute myeloid leukemia， kidney， pancreatic， breast， lung and ovarian cancer， etc。 As one of the crucial signaling pathways promoting tumor growth and metastasis， immune escape and drug resistance， GAS6-AXL pathway is considered to be an attractive target for cancer treatment and has attracted widespread attention。
“The agreement with SignalChem will further advance Xuanzhu‘s pipeline in the solid tumor and hematoma space。 The results from preclinical and phase 1 clinical development demonstrate SLC-391 superiority not only as SLC-391 has prominent single-agent activities in multiple solid and hematological tumors but also can potentially be administrated with a variety of drugs under development at Xuanzhu。 Both parties will use their respective resources to accelerate the clinical approval of SLC-391 in China，” said Ms。 Xu Yanjun， Chairman of Xuanzhu。 “Xuanzhu will continue to expand its efforts to develop and commercialize innovative drugs in the oncology field。”
“Xuanzhu Biopharmaceutical， a subsidiary of Sihuan Pharmaceutical， is a highly innovative and progressive company，” commented by Mr。 Jun Yan， the Chairman and President of SignalChem， “We are very pleased to establish a partnership with Xuanzhu。 This licensing agreement is of great significance for SignalChem to further validate and expand SLC-391’s clinical superiority。 This agreement will accelerate SLC-391’s development timeline to reach the market and provide more effective treatment alternatives for patients with cancer。” Mr。 Jun Yan added， “the size of the agreement， including upfront， milestone and royalties， with Xuanzhu may be one of the largest agreements signed in Canada with a Chinese bio-pharma company for the Chinese territory rights， and we are looking forward to reaching all anticipated objectives。 Furthermore， SignalChem will continue its efforts to expand and accelerate clinical development with SLC-391 for wider indications in even more geographic territories。”
# About SLC-391 #
SLC-391 is a potent， highly selective and orally bioavailable small molecule AXL inhibitor。 Preclinical investigational data shows SLC-391 is a superior AXL inhibitor and has the potential to become a first-in-class inhibitor。 Phase I clinical study is currently underway in Canada。 SignalChem has established a collaboration with Merck （MSD） to evaluate the efficacy of SLC-391 in combination with Keytruda® （pembrolizumab） for the treatment of advanced non-small cell lung cancer （NSCLC）。 In pre-clinical studies， SLC-391 demonstrated strong efficacy as a single agent or in combination with other approved drugs in multiple animal models for cancer。 SLC-391 will be developed to undisclosed cancer indications as a single agent or in combination with other therapies。
About Xuanzhu
Xuanzhu Biopharmaceutical Co。， Ltd。， a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd。， is an innovative biopharmaceutical company rooted in China with a global perspective， focusing on tumors， metabolic diseases， infections， and other fields。 It has a layout of the entire industry chain from drug discovery， preclinical research， clinical development， and production commercialization。 Our strengths reside in our detailed knowledge and expertise in the clinical development and regulatory approval processes in China。 Xuanzhu has a clinical and regulatory team of over 300 people bringing expertise from numerous multinational pharmaceutical companies including J&J， Lilly， Merck， Novartis， Pfizer， and Roche。 This combined with the most extensive sales and marketing capability in China， places Xuanzhu as the premier partner for those companies with innovative assets desiring to enter the China domestic market。
About SignalChem Lifesciences Corporation
SignalChem Lifesciences Corporation， headquartered in Richmond， British Columbia， Canada， is a clinical-stage company developing novel targeted therapies for oncology。 Its unique business model has been built upon four important pillars： Drug Discovery and Development， the Bioreagents and Research Services business， In-Vitro Diagnostic Reagent Development and Plant Biosynthesis Systems。 We at SignalChem are a group of scientists with extraordinary expertise and experience in protein engineering and drug discovery who are working together cohesively to provide the best products and services to our customers around the world and to maximize the efficiency of our own drug discovery efforts。
Xuanzhu Forward-Looking Statements
These statements are only predictions based upon our current expectations and projections about future events。 Forward-looking statements are subject to known and unknown risks， uncertainties and other factors that may cause the actual results， level of activity， performance or achievements of Xuanzhu to be materially different from those expressed or implied by such forward-looking statements。 Although Xuanzhu has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements， there may be other factors that cause results not to be as anticipated， estimated or intended。 You should not rely on forward-looking statements as a prediction of future events。
The assumptions used in the preparation of this statement although considered reasonable by Xuanzhu at the time of preparation， may prove to be incorrect。 Recipients are cautioned that the information is based on assumptions as to many factors and that actual results may vary from the results projected and such variations may be material。 Accordingly， readers should not place undue reliance on any forward-looking statements contained herein。 Xuanzhu does not undertake to update any forward-looking statements， except in accordance with applicable securities laws。
SignalChem’s Forward-Looking Statements
These statements contain forward-looking statements， including statements about SignalChem’s business strategy， product development， regulatory matters， manufacturing plans， and intellectual property plans。 For this purpose， any statement that is not a statement of historical fact should be considered a forward-looking statement。 SignalChem’s business is subject to numerous risks and uncertainties。 SignalChem has never commercialized any drug products and it is uncertain whether its product candidates under development will become effective treatments。 SignalChem’s product candidates are still in an early stage of development， have not completed clinical development and have not received regulatory approval for commercialization。 SignalChem may not actually achieve the plans， projections， or expectations set forth in its forward-looking statements。 Actual results or events could differ materially from the plans， projections， and expectations set forth in its forward-looking statements， as a result of the risks affecting its business。
Xuanzhu Biopharmaceutical Co., Ltd.
Deyan Hou
Business Development
+86 186 1269 2542
SignalChem Lifesciences Corporation
Zaihui Zhang， PhD
CSO， VP R & D
+ 604 232 4600 ext。 114