CellPoint BV

Key 2022 and post-period events Dr. Paul Stoffelsi appointed as Chief Executive Officer and Chairman of the Board of DirectorsImplemented new strategic direction to accelerate innovation and time-to-patients: Set-up of new innovation model and fit-for-purpose R&D organizationFocus on key therapeutic areas of immunology and oncologyDiscontinuation of activities in fibrosis and kidney diseaseExpansion of drug modalities beyond small molecules, including biologicals and CAR-T Entered into the field of oncology through the acquisitions of CellPoint and AboundBioPresented encouraging initial safety and efficacy data from two ongoing Phase 1/2 studies in patients with refractory/relapsed non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL) with CD19 CAR-T candidates, GLPG5101 and GLPG5201, manufactured at point-of-careJyseleca® sales of €87.6 million, at the upper end of the guidance of €80-90 millionJyseleca® reimbursed for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 11 countriesThe Committee for Medicinal Products for Human Use (CHMP) adopted the Pharmacovigilance Risk Assessment Committee (PRAC)’s recommendation to harmonize the European label of all approved JAK inhibitors for chronic inflammatory disorders following an extensive safety review (Article 20 procedure) Received positive opinion from the CHMP for Jyseleca® European label update based on testicular function safety data from MANTA/RAy semen parameter studiesAnnounced topline results from Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease and, based on these topline data, decided not to submit a Marketing Authorization Application in Europe 2022 financial results Group net revenues of €505.3 million compared to €484.8 million in 2021Operating loss of €267.5 million compared to €165.6 million in 2021Net loss of €218.0 million compared to €103.2 million in 2021Cash and current financial investments of €4.1 billion on 31 December 2022Operational cash burnii of €513.8 million, which is within the guided range Webcast presentation tomorrow, 24 February 2023, at 14.00 CET / 8 AM ET, www.glpg.com Mechelen, Belgium; 23 February 2023, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) reports 2022 results, supported by strong adoption of Jyseleca® across Europe, and provides outlook for 2023. Commenting on the full year results 2022, Dr. Paul Stoffels, CEO and Chairman of the Board of Directors of Galapagos said: “As I reflect on my first year as the new CEO and Chairman, we can be proud of what we have achieved in a very short time to reset our organization and embrace a new R&D strategy for a sustainable future. 2022 was a year of transformation and change. Adding oncology as a new strategic therapeutic area, and CAR-T and biologicals as novel drug modalities, were key steps in our transformation. Through the acquisitions of CellPoint and AboundBio, we gained access to a breakthrough, point-of-care CAR-T manufacturing platform, a clinical-stage CAR-T oncology pipeline and a research engine for novel, differentiated CAR-T constructs, that together have the potential to deliver life-saving medicines to more patients, faster and more efficiently. In addition, we remain fully committed to immunology, an area where there is still significant unmet patient need and for which we have built deep scientific know-how and expertise since our founding. With our programs targeting multiple modes-of-action and drug modalities, most recently including CAR-T, we have a differentiated portfolio of preclinical through to commercial assets.” Bart Filius, President, COO and CFO of Galapagos, added: “We are very proud that our first marketed medicine, Jyseleca®, an orally administered JAK1 preferential inhibitor, continued to deliver solid in-market performance with a growing European base and €87.6 million in net sales for the year 2022, reaching 18,000 patients with RA and UC across Europe. Based on the topline results from the Phase 3 DIVERSITY study of filgotinib in Crohn’s disease, Galapagos decided not to submit a Marketing Authorization Application in Europe in this indication. On the other hand, following the positive opinion from the Committee for Medicinal Products for Human Use on the Type II variation application based on the safety data on semen parameters from the MANTA and MANTA-RAy studies, the European label for RA and UC has been updated, potentially broadening access for European patients who may benefit from this treatment. For 2023, we anticipate net Jyseleca® sales in a range between €140 and €160 million. For the longer term, we believe Jyseleca® can reach €400 million peak sales in RA, UC and axial spondyloarthritis. Financially, we ended 2022 with a strong balance sheet of €4.1 billion in cash and current financial investments, which provides us with the necessary means to look for additional external innovation to accelerate our R&D portfolio while progressing our internal programs. As part of our company transformation, we have meaningfully reduced our cost base. We anticipate our full year 2023 operating cash burn to decline to a range of €380 to €420 million.” 2022 operational review and post-period events Jyseleca® commercial & regulatory progress Adoption across Europe with reimbursement for RA in 15 countries and for UC in 11 countriesSobi, our distribution and commercialization partner in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in RA in the Czech Republic and Portugal, resulting in €2.0 million milestone payments to Galapagos The Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the Ministry of Health, Labour and Welfare (MHLW) in Japan approved filgotinib 200mg for the treatment of moderate to severe UCThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, CHMP, adopted the recommendation of the PRAC to add measures to minimize risk of serious side effects with JAK inhibitors used for chronic inflammatory disordersPositive opinion issued by the CHMP for Jyseleca’s® European label update based on testicular function safety data from MANTA/RAy semen parameter studies Pipeline update Started preparations to initiate a Phase 2 program with TYK2 inhibitor GLPG3667 in dermatomyositis (DM) and systemic lupus erythematosus (SLE)Discontinued our activities in fibrosis and kidney disease as a result of our new strategic therapy area focusPhase 2 study with GLPG2737 in polycystic kidney disease is ongoing with topline results expected in the first half of 2023. If successful, we aim to outlicense the programHalted development of SIK3 inhibitor GLPG4399; medicinal chemistry activities to identify SIK inhibitors with improved pharmacology continuesReported initial encouraging safety and efficacy data at ASH1 2022 from the ongoing ATALANTA-1 Phase 1/2 study in refractory/relapsed NHL with CD19 CAR-T candidate, GLPG5101, manufactured at point-of-care Corporate update Appointed Dr. Paul Stoffels as Chief Executive Officer, succeeding Onno Van de Stolpe, as of 1 April 2022. Following approval by Galapagos’ shareholders on 26 April 2022, adopted a 1-tier governance model and Dr. Paul Stoffels was appointed Chairman of the Board of DirectorsImplemented new strategic direction to accelerate innovation and time-to-patients, focused on key therapeutic areas of immunology and oncology, diversifying beyond small molecules to include CAR-T and biologicals, and set up of a fit-for-purpose R&D organizationEntered the field of oncology through the acquisitions of CellPoint and AboundBio in all-cash transactions against payment of an upfront amount of €125 million for CellPoint, with an additional €100 million to be paid upon achievement of certain milestones, and against payment of $14 million for AboundBioReceived various transparency notifications from EcoR1 Capital LLC and FMR LLC, indicating that their shareholding in Galapagos increased, crossing the 5% threshold, to 5.2% and 5.9% respectively, of our current outstanding sharesRaised €6.7 million through the exercise of subscription rightsAnnounced changes to the Executive Committee: Dr. Walid Abi-Saab (Chief Medical Officer) and Dr. André Hoekema (Chief Business Officer) retired from the company, and Valeria Cnossen (General Counsel) and Annelies Missotten (Chief Human Resources Officer) were appointed as new members of the Executive Committee as of 1 January 2023 Post-period events Poster presentation at the annual EBMT-EHA2 congress demonstrating initial encouraging safety and efficacy results from the ongoing EUPLAGIA-1 Phase 1/2 study with point-of-care manufactured CD19 CAR-T candidate, GLPG5201, in patients with refractory/replapsed CLL and small lymphocytic lymphoma (rrSLL), with or without Richter’s transformation (RT). All 7 out of 7 eligible rrCLL patients, including 4 patients with RT, responded to treatment (Objective Response Rate of 100%), and GLPG5201 showed an acceptable safety profile with no cytokine release syndrome (CRS) higher than grade 2, and no immune effector cell-associated neurotoxicity syndrome (ICAN) observedAnnounced topline results from the DIVERSITY study, a combined induction and maintenance Phase 3 study of filgotinib in Crohn’s disease. While the co-primary endpoints for filgotinib 200mg in the maintenance part of the study were met and the observed safety profile is consistent with its known safety profile, the two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data Financial performance Key figures 2022 (consolidated)(€ millions, except basic & diluted loss per share) 31 December 2022 group total 31 December 2021 group total Product net sales 87.6 14.8 Collaboration revenues 417.7 470.1 Total net revenues 505.3 484.8 Cost of sales (12.1) (1.6) R&D expenditure (515.1) (491.7) G&Aiii and S&Miv expenses (292.5) (210.9) Other operating income 46.8 53.7 Operating loss (267.5) (165.6) Fair value adjustments and net exchange differences 51.5 61.3 Net other financial result 0.9 (18.7) Income taxes (2.8) (2.4) Net loss from continuing operations (218.0) (125.4) Net profit from discontinued operations 22.2 Net loss of the period (218.0) (103.2) Basic and diluted loss per share (€) (3.32) (1.58) Current financial investments and cash and cash equivalents 4,094.1 4,703.2 Details of the financial resultsOur net revenues in 2022 amounted to €505.3 million compared to €484.8 million in 2021. We reported product net sales of Jyseleca® in Europe in 2022 amounting to €87.6 million, compared to €14.8 million last year. Cost of sales related to Jyseleca® net sales in 2022 amounted to €12.1 million, compared to €1.6 million in 2021. Collaboration revenues amounted to €417.7 million in 2022, compared to €470.1 million last year. The revenue recognition linked to the upfront consideration and milestone payments in the scope of the collaboration with Gilead for filgotinib, amounted to €174.4 million in 2022 (compared to €235.7 million in 2021). This decrease was due to a lower increase in the percentage of completion, slightly offset by higher revenue recognition of milestone payments, strongly influenced by the milestone achieved in 2022 related to the regulatory approval in Japan for UC. On 8 February 2023 we announced topline results from the Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease and, based on these topline data, decided not to submit a Marketing Authorization Application in Europe. While this recent event will not have an impact on our financial statements for the year ended 31 December 2022, we will provide further information in our 2022 annual report on the potential revenue recognition impact on our financial statements for the year ended 31 December 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €230.4 million in 2022 (compared to €230.6 million in 2021). We also recognized royalty income from Gilead for Jyseleca® for €10.7 million in 2022 (compared to €3.8 million in 2021). Additionally, we recorded in 2022 milestone payments of €2.0 million triggered by the inital sales of Jyseleca® in Czech Republic and Portugal by our distribution and commercialization partner Sobi. Our deferred income balance at 31 December 2022 includes €1.5 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and €0.5 billion allocated to the development of filgotinib which is recognized over time until the end of filgotinib’s development period. Our R&D expenditure in 2022 amounted to €515.1 million, compared to €491.7 million in 2021. Depreciation and impairment costs in 2022 amounted to €54.5 million (compared to €17.5 million in 2021). This increase was primarily due to an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716) and impairments of intangible assets related to other discontinued projects recorded in 2022. Personnel costs increased from €165.2 million in 2021 to €190.1 million in 2022 primarily related to increases in restructuring costs and accelerated non-cash cost recognition for subscription right plans related to good leavers. This was partly offset by a decrease in subcontracting costs from €251.1 million in 2021 to €214.9 million in 2022 following the evolution of our programs. Our G&A and S&M expenses amounted to €292.5 million in 2022, compared to €210.9 million in 2021. This increase was primarily due to the termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead for filgotinib in 2022 which explains €59.7 million of the variance. The cost increase was also explained by an increase in personnel costs of €26.6 million in 2022 compared to 2021, which are related to an increase in our commercial work force driven by the commercial launch of filgotinib in Europe, accelerated non-cash cost recognition for subscription right plans related to good leavers and restructuring costs. Other operating income (€46.8 million in 2022 compared to €53.7 million in 2021) decreased, mainly driven by lower grant and R&D incentives income. We reported an operating loss amounting to €267.5 million in 2022, compared to an operating loss of €165.6 million in 2021. Net financial income in 2022 amounted to €52.4 million, compared to €42.6 million in 2021. Net financial income in 2022 was primarily attributable to €41.3 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €6.9 million of positive changes in the (fair) value of our current financial investments. The other financial expenses also had the effect of discounting our non-current deferred income of €7.7 million. Net interest income amounted to €11.1 million in 2022 compared to €8.8 million of net interest expense in 2021. We reported a group net loss in 2022 of €218.0 million, compared to a group net loss of €103.2 million in 2021. Cash positionCurrent financial investments and cash and cash equivalents totaled €4,094.1 million on 31 December 2022, as compared to €4,703.2 million on 31 December 2021. Total net decrease in cash and cash equivalents and current financial investments amounted to €609.1 million in 2022, compared to a net decrease of €466.1 million in 2021. This net decrease was composed of (i) €513.8 million of operational cash burn, offset by (ii) €6.9 million positive changes in (fair) value of current financial investments and €44.5 million of mainly positive exchange rate differences, (iii) €6.7 million of cash proceeds from capital and share premium increase from exercise of subscription rights in 2022, and (iv) €153.4 million cash out from the acquisitions of CellPoint and AboundBio, net of cash acquired. Acquisition of CellPoint and AboundBioWe have completed the initial accounting of the acquisitions of Cellpoint and AboundBio, including the purchase price allocations. Disclosures on the business combinations will be included in our full year 2022 annual report. Outlook 2023 Immunology franchiseThis year, we expect additional reimbursement decisions for Jyseleca® in UC in Europe, and we anticipate that Sobi will further progress with reimbursement discussions in RA and UC in Eastern and Central Europe, Greece, and the Baltic countries. We also expect the final decision from the European Commission following CHMP’s adoption of the recommendation of the PRAC to harmonize the EU labels of all approved JAK inhibitors. We plan to start a Phase 3 study in axial spondyloarthritis, and anticipate announcing the initial results from the FILOSOPHY Real-World Evidence Phase 4 study in RA. We aim to recruit the first patients in the Phase 2 programs with our TYK2 inhibitor product candidate, GLPG3667, in DM in the first quarter of 2023, followed by the start of a study in SLE later this year. To accelerate time-to-patients, we are diversifying our drug modality capabilities in immunology and recently announced that we aim to start clinical development with the CD19 CAR-T candidate, GLPG5101, in refractory systemic lupus erythematosus (rSLE). Oncology portfolio Patient recruitment in the European sites of the ATALANTA-1 Phase 1/2 study with CD19 CAR-T candidate, GLPG5101, in rrNHL as well as in the EUPLAGIA-1 study with CD19 CAR-T candidate GLPG5201 in rrCLL/SLL is progressing. We aim to provide Phase 1 topline results from both studies around mid-2023 and aim to include US patients in 2023. We aim to expand the CAR-T portfolio with a BCMA CAR-T product candidate, GLPG5301, in refractory/relapsed multiple myeloma (rrMM) and aim to start enrolling patients in the PAPILIO-1 Phase 1/2 study in Europe in the second quarter of 2023. Financial guidance For the full year 2023, we anticipate further reduction of our cash burn and anticipate landing between €380 and €420 million (compared to €514 million for the full year 2022), including the acceleration in oncology. We also anticipate between €140 and €160 million net sales of Jyseleca® for the full year 2023. Taking into account multiple factors, we have revised our estimates of the peak sales potential for Jyseleca® in RA, UC and axial spondyloarthritis and expect this to reach €400 million by the end of the decade. Annual report 2022We are currently finalizing the financial statements for the year ended 31 December 2022. Our independent auditor has confirmed that its audit procedures are substantially completed and have not revealed any material corrections required to be made to the financial information included in this press release. Should any material changes arise during the audit’s finalization, an additional press release will be issued. We aim to publish the fully audited annual report for the full year 2022 on, or around, 23 March 2023. Conference call and webcast presentationWe will host a conference call and webcast presentation tomorrow 24 February 2023, at 14:00 CET / 8 AM ET. To participate in the conference call, please register in advance using this link. Upon registration, the dial-in numbers will be provided. The conference call can be accessed 10 minutes prior to the start time by using the conference access information provided in the e-mail received at the point of registering, or by selecting the call me feature. The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website. Financial calendar Date Details 23 March 2023 Publication Annual Report 2022 and 20-F 2022 25 April 2023 Annual Shareholders’ meeting 4 May 2023 First quarter 2023 results (webcast 5 May 2023) 3 August 2023 Half Year 2023 results (webcast 4 August 2023) 2 November 2023 Third quarter 2023 results (webcast 3 November 2023) 22 February 2024 Full year 2023 results (webcast 23 February 2024) About Galapagos Galapagos is a fully integrated biotechnology company focused on discovering, developing, and commercializing innovative medicines. We are committed to improving patients’ lives worldwide by targeting diseases with high unmet needs. Our R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs in immunology, oncology, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter. Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies. Except for filgotinib’s approval as Jyseleca® for the treatment of moderate to severe RA and UC by the relevant regulatory authorities in the European Union, Great Britain, and Japan, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority. Contacts Media relations Investor relations Marieke Vermeersch Sofie Van Gijsel +32 479 490 603 +1 781 296 1143 Elisa Chenailler Sandra Cauwenberghs +41 79 853 33 54 +32 495 58 46 63 ir@glpg.com Hélène de Kruijs +31 6 22463921 media@glpg.com Forward-looking statementsThis press release contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements made in the sections captioned “2022 operational review and post-period events” and “Outlook 2023”, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash and estimated peak sales for Jyseleca® during the financial year 2023), statements regarding the acquisitions of CellPoint and AboundBio, including statements regarding anticipated benefits of the acquisitions and the integration of CellPoint and AboundBio into our portfolio and strategic plans, statements regarding our regulatory outlook, statements regarding the amount and timing of potential future milestones, and other payments , statements regarding our R&D plans, strategy and outlook, including progress on our immunology or oncology portfolio, CAR-T-portfolio and our SIKi portfolio, and potential changes in such strategy, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future approved products, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), statements regarding the global R&D collaboration with Gilead and the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, statements regarding the expected timing, design and readouts of our ongoing and planned preclinical studies and clinical trials, including but not limited to (i) filgotinib in RA, UC and AxSpA, (ii) with SIKi compounds, including GLPG3667 in SLE and DM, (iii) GLPG2737 in autosomal dominant polycystic kidney disease (ADPKD), (iv) GLPG5101 in rrNHL and rSLE, (v) GLPG5201 in rrCLL and rrSLL, and (vi) GLPG5301 in rrMM, including recruitment for trials and topline results for trials and studies in our portfolio, statements relating to interactions with regulatory authorities, statements related to the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including filgotinib, initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004 and regarding the related CHMP opinion, statements regarding the CHMP opinion for filgotinib, statements about the European label update based on testicular function safety data from MANTA/RAy studies, statements relating to the timing or likelihood of additional regulatory authorities’ approval of marketing authorization for filgotinib for RA, UC or any other indication, statements regarding the changes in our leadership and expected resulting benefits, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the development of our commercial organization, statements and expectations regarding the rollout of our products or product candicates (if approved) in Europe, statements related to the expected reimbursements for Jyseleca®, statements regarding patient enrollment for the Phase 2 programs with our TYK2 inhibitor product candidate, GLPG3667, and the timing for the start of a study in SLE, statements regarding the timing of clinical development with our CD19 CAR-T candidate, GLPG5101, in rSLE, statements regarding the progress of patient recruitment efforts in the European sites of the Phase 1/2 ATALANTA-1 study with our CD19 CAR-T candidate, GLPG5101, in rrNHL as well as in the EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, in rrCLL/SLL, and the timing for Phase 1 topline results from such studies, statements regarding the timing for expansion of, and patient enrollment in, the CAR-T portfolio with a BCMA CAR-T product candidate, GLPG5301, in refractory/relapsed multiple myeloma (rrMM), and portfolio goals, business plans, and sustainability plans. Galapagos cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause actual events, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2023 revenues, operating expenses, cash burn and other financial results may be incorrect (including because one or more of its assumptions underlying our revenue or expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from Galapagos’ ongoing and planned clinical research programs in rheumatoid arthritis, ulcerative colitis, dermatomyositis, systemic lupus erythematosus, axial spondyloarthritis, autosomal dominant polycystic kidney disease, refractory/relapsed Non-Hodgkin lymphoma, refractory/replapsed chronic lymphocytic leukemia, refractory/replapsed small lymphocytic lymphoma, refractory/relapsed Multiple Myeloma and other immunologic indications or any other indications or diseases, may not support registration or further development of its product candidates due to safety or efficacy concerns or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated benefits of the acquisitions of CellPoint and AboundBio, the inherent risks and uncertainties associated with target discovery and validation and drug discovery and development activities, risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead), the risks related to the timing and implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the transfer of the supply chain, the risk that the transition will not have the currently expected results for our business and results of operations the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, including the risk that our plans with respect to CAR-T may not be achieved on the currently anticipated timeline or at all, the risk that our projections and expectations regarding the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risks related to our strategic transformation exercise, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all, the risk that we will be unable to successfully achieve the anticipated benefits from our leadership transition, the risk that we will encounter challenges retaining or attracting talent, risks related to disruption in our operations, supply chain or ongoing studies due to the conflict between Russia and Ukraine, risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities and the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMA’s planned safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future, and the risks and uncertainties related to the impact of the COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (“SEC”), including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. 1 Annual Society of Hematology2 European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) i Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’ii The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:• the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities• the net proceeds or cash used, if any, related to the acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, the cash advances and loans given to third parties, if any, included in the net cash flows generated from/used in (-) investing activities• the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash flows generated from/used in (-) operating activities.This alternative liquidity measure is in our view an important metric for a biotech company in the development stage. The operational cash burn for the year 2022 amounted to €513.8 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €1,747.5 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €6.7 million, (ii) the net purchase of current financial investments amounting to €1,087.0 million, and (iii) the cash out from acquisition of subsidiaries, net of cash acquired, of €153.4 millioniii General and administrativeiv Sales and marketing Attachments fy22_financial_tables_en Galapagos announces full year 2022 results and outlook for 2023

产品竞争力将成为新药出海需跨过的首要难关，而临床开发能力、海外申报注册的能力、商业化能力和全球产业链能力则决定着药企全球化之路能走多远。如果说“出海”从前还是中国创新药企的梦想，那么从2022年开始，它已几乎成了一种战略上的标配。据不完全统计，开年至今，国内共有超过100家药企发生了“出海”事件。光是上半年，就有超过50家创新药企在积极推进“出海”业务，有的是已在FDA和欧盟递交海外上市申请的“自主出海”，还有的是与跨国制药巨头达成License-out战略合作。其中，较为活跃的前十家企业分别是：恒瑞医药、百济神州、君实生物、翰森制药、信达生物、科伦药业、荣昌生物、亿帆医药、和黄医药，还有诺诚健华。而从出海的产品趋势上看，也正在从以大分子创新药向新型技术平台的转向过程中。以今年为例，ADC药物就几乎一骑绝尘，接棒了去年以单抗药物为主的创新药出海趋势。从科伦到石药再到礼新等药企，国内产品的License-out正在让这个赛道持续升温。不过，License-out的渐入佳境仍不能掩盖自主出海之路的“阻与长”。从FDA近年的新药审批趋势能够看到，其标准正日渐趋严。今年上半年，FDA批准新药数量仅为16款，远低于2021年和2020年同期的29款和26款。且最近几年，其批准的新药中Me-too和Me-better的比例已在逐年下降，FIC和BIC的占比则在提升。这也意味着，产品竞争力将成为新药出海首先要跨过的难关。除此之外，药企的临床开发能力、海外申报注册的能力、商业化能力和全球产业链能力也都决定着全球化之路能走多远。01自主出海：部分临床已进入关键期根据西南证券的不完全统计，目前国内有139个创新药正在海外进行233项临床试验，分属于38家上市公司。若按照临床试验项目数量来看，百济神州、恒瑞医药、加科思、康方生物、复星医药、亚盛医药等公司可望凭借丰富的出海管线，未来在海外市场收获一席之地和高额回报。其中，百济神州的替雷利珠单抗和泽布替尼、康方生物的派安普利单抗、绿叶制药的LY03004和 LY03005、君实生物的特瑞普利单抗、腾盛博药的安巴韦单抗/罗米司韦单抗、和黄医药的索凡替尼、亿帆医药的F-62等处于NDA阶段。除此之外，随着创新药推进至关键临床，药企也将并逐渐步入收获期。据不完全统计，上述临床试验中目前有33个临床项目处于III期，有望于2023年-2024年上市。其中，恒瑞医药7个项目，百济神州6个项目，君实生物4个项目。而这些III期项目中，也有很多被市场寄予厚望。其中包括，恒瑞的“双艾方案”一线治疗晚期肝细胞癌；复宏汉霖的斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌和局部晚期/转移性食管鳞癌，特别是一线广泛期小细胞肺癌，在美国依然存在巨大的临床需求；贝达药业的恩沙替尼一线治疗ALK阳性NSCLC患者，与克唑替尼相比，恩沙替尼PFS有显著优势，以及百济神州的帕米帕利一线治疗铂敏感复发性胃癌，虽然数据尚未披露，但目前全球尚无PARP抑制剂用于铂敏感复发性胃癌的维持治疗，也有望成为“全球新”。02License-out：ADC成主力除了国际临床试验，License-out更因能有效降低风险，快速回笼资金，而成为出海的主流方式。不过，License-out也有门槛，国外企业在遴选产品时，十分注重技术平台，且通常需要合作产品进入临床II期。根据西南证券的统计，今年上半年国内药企的License-out数量超过20个。随着国内新药创制水平的不断提升，国产创新药的国际认可度稳步上升，国产创新药License-out金额也持续攀升，目前约有共14个License-out项目的总交易金额超5亿美元。相比2021年以单抗药物为出海主力，今年的ADC似有比肩之势。截止发稿日，涉及ADC的出海交易超过6笔，远超双抗、CAR-T等领域出海情况。本就火热的ADC（抗体偶联药物）赛道，今年因DS-8201（Trastuzumab deruxtecan；T-DXd；ENHERTU®）好消息频出又持续升温。在今年6月举行的美国临床肿瘤学会（ASCO）第58届年会上，阿斯利康和第一三共联合研发的ADC DS-8201因其III期临床试验DESTINY-Breast04数据证明获益人群可从HER2阳性拓展至HER2低表达患者而收获全场掌声。紧接着，DS-8201在欧盟被批准用于既往接受过一种或多种基于抗HER2治疗方案的HER2阳性转移性乳腺癌患者。DS-8201不仅为乳腺癌患者带来新希望，也让ADC赛道焕发新生机。今年8月，科伦药业发布公告展示了其控股子公司科伦博泰与默沙东进行的两款ADC产品（项目A、B）有偿独家许可交易情况。项目A为SKB-264，是一款靶向TROP2的ADC。科伦博泰以超14亿美元的价格将SKB-264中国以外的研究、开发、生产制造和商业化权益许可给默沙东。项目B药物为一款用于治疗实体瘤ADC药物，科伦博泰以9.36亿美元将其全球范围内研究、开发、生产制造与商业化权益售出。而石药集团子公司巨石生物以11.95亿美元将抗Claudin 18.2 ADC产品SYSA1801在大中华地区以外地区的开发及商业化权益授予Elevation Oncology公司也受到颇多关注。此外，礼新医药超10亿美元将Claudin18.2 ADC新药LM-302的除大中华区和韩国外的全球权益授予Turning Point公司；普众发现与昂阔医药（OnCusp Therapeutics）就靶向CDH6的ADC产品AMT-707（CUSP06）开发和商业化权益达成许可协议；多禧生物与强生就至多5个靶点开发新型ADC药物达成合作……可见ADC赛道的红火。相比ADC赛道交易不断，单抗、双抗和CAR-T细胞疗法赛道稍显温和。今年年初，君实与Coherus就TIGIT单抗JS006达成合作。Coherus启动行使JS006在美国和加拿大的许可选择权，向君实支付3500万美元首付款，最高达2.55亿美元的开发、申报和销售里程碑付款，以及产品销售净额18%的销售分成。这也是君实与Coherus就PD-1单抗特瑞普利单抗注射液（商品名：拓益）达成合作后的又一授权交易。今年3月，天演药业与赛诺菲就天演药业独有的安全抗体SAFEbody®技术开展多靶点合作，开发新一代掩蔽抗体候选药物，全部合作交易金额潜值25亿美元以及特许权使用费。这一消息也让业内对抗体技术平台出海有了新的认识。作为今年业内为数不多的出海双抗药物，和铂医药与阿斯利康超3.5亿美元的合作点燃了今年4月的热门话题。和铂医药与阿斯利康就CLDN18.2xCD3 双特异性抗体HBM7022的开发与商业化达成全球对外授权协议。HBM7022 是由和铂医药基于公司 HCAb 的免疫细胞衔接器平台 HBICE® 开发的一种新型双特异性抗体，目前正处于临床前阶段。而信达、驯鹿与Sana Biotechnology公司合作的好消息则掀起了业内对CAR-T细胞疗法及技术平台海外授权的新一波关注。驯鹿与信达授予Sana其BCMA CAR结构的非商业权利，应用于Sana特定的细胞治疗产品开发。驯鹿和信达可获得首付款以及有资格获得最多6个产品、约为2.04亿美元的潜在开发、注册里程碑付款和销售分成。今年4月，普瑞金生物宣布与欧洲CellPoint B.V.公司就靶向BCMA的CAR-T细胞疗法PRG-1801达成授权合作。CellPoint B.V.公司将获得普瑞金自主开发的PRG-1801用于血液肿瘤适应证的欧美权益，并负责该产品在欧美地区的临床开发和商业化。普瑞金将获得超过2000万欧元的首付款，以及金额可观的各阶段里程碑付款和超过10%的商业化销售提成。总体而言，ADC赛道已成今年出海主力军之一，单抗、双抗及CAR-T出海趋势相对平稳。相信随着国内产品更加成熟，会有越来越多的公司主动出海；技术平台有新突破后，也会迎来海外公司新一轮的青睐。03出海进入3.0时代根据BCG的研究，中国创新药的出海已从产品授权驱动的1.0时代出发，走过全球多中心临床的2.0阶段，来到了自建或合作建立国际化营销网络的3.0时代。在国际化战略上，各大药企都在进行不遗余力的投入和尝试。而率先进入3.0的药企，也将最先在出海中获利。以百济神州为例，其在海外建立的商业化团队显然也在发挥作用。该公司中报显示，2022年上半年，百悦泽（泽布替尼）在全球实现2.331亿美元的销售额，同比大增261.3%。其中在美国的销售更增长5倍，达到1.563亿美元。尽管已取得不俗的成绩，市场仍认为，泽布替尼距离峰值销售额还很遥远，主要原因是其核心适应证慢性淋巴细胞白血病/小细胞淋巴瘤(cLL/sLL)尚未获批。而该适应证也正是原研药伊布替尼放量的关键。4月12日，经独立审查委员会确认，泽布替尼在复发或难治性(R/R) cLL/sLL患者中展现出优于伊布替尼的总缓解率。考虑到泽布替尼在与伊布替尼的头对头试验中胜出，市场普遍预计泽布替尼通过FDA审批的概率将变大，而其PDUFA日期预计为2023年1 月，这一时间也因而成为被市场高度关注的时点。不过，虽然百济神州的泽布替尼和传奇生物的西达基奥仑赛，都是以更优的临床数据叩开了FDA的大门。但今年以来，FDA批准新药的数量明显减少且治疗领域更加多样，这给即将出海的药企提供了一个信号：差异化创新已是势在必行。曾有专家指出，全球大分子靶点超过100个，中国的研发只集中在最热的前12%，小分子前100的靶点中，中国也只集中研究前40%。这让中国创新药企在六七年时间里就用各种方式把全球卖得最好的药都开发殆尽，同质化竞争严重。可反观今年上半年FDA对新药的批准动作，已似乎在有意地“去同质化”。其上半年批准的16款新药中，肿瘤药物仅有4款，占比约25%。而去年同期则高达12款，占比44%。其他获批药物的治疗领域则包括失眠、特应性皮炎、血液类疾病等。与此同时，获批企业也绝大部分为中小型生物技术公司，高达10家。而仔细盘点上半年的创新药出海遇阻的案例，也可以让我们一窥出海之路所要“踩的坑”。从遇阻的原因来看，信迪利单抗和索凡替尼几乎都是因为均缺少代表美国患者人群的国际多中心临床试验数据；而特瑞普利单抗和艾贝格司亭α注射液则主要因为新冠疫情导致的现场核查受阻。而这也给我们的出海带来了一个有益的启示，那就是在确保“创新性”和“差异化”的前提下，在研究和申报程序上，也应全面符合美国药品监管的体系要求，这其中也包括美国患者的临床数据和国际多中心临床试验。而对于所有潜在的风险，企业也要做好应对，其中包括疫情导致的风险。登记邮箱信息订阅E药经理人信息服务扫描二维码

前言根据GBI SOURCE数据库交易板块数据，2022年4月以来，国内生物制药公司披露了涵盖肿瘤、免疫、神经系统、抗感染等领域的二十多笔引进（license-in，指从境外企业引进）和授权（license-out，指对跨国企业授权）交易。引进交易包括多笔眼科药物相关交易，还有颇受关注的第一三共将中国大陆地区可乐必妥制剂相关业务转让给重庆药友制药，以将公司资源更多地集中在肿瘤领域。授权交易包括阿斯利康3.5亿美元获得和铂医药双抗HBM7022全球独家权益；普瑞金生物授予CellPoint靶向BCMA的CAR-T疗法欧美权益等。本期，小G将对2022年4月以来license-in/out情况进行盘点，速来围观收藏啦！引进交易License-in第一三共向复星医药子公司出售业务■  许可方：第一三共■  被许可方：重庆药友制药■  产品/技术：左氧氟沙星 第一三共（中国）与复星医药子公司重庆药友制药签署股权转让协议，向重庆药友转让大陆地区可乐必妥制剂的生产销售权和生产该制剂的生产公司全部股权，预计将于今年8月底完成转让，本次交易转让价格并未公开。交易完成后，重庆药友将拥有第一三共制药（北京）公司100%股权以及其产品可乐必妥片剂（0.1g*4片、0.5g*10片）和针剂（100ml:0.5g、50ml:0.25g、150ml:0.75g）在中国大陆（不包括港澳台）的产品权利。奥赛康药业引进Propella治疗骨关节炎疼痛产品■  许可方：Propella Therapeutics, Inc.■  被许可方：奥赛康药业■  产品/技术：CGS-200-5美国生物制药公司Propella Therapeutics与江苏奥赛康药业签订产品许可协议。根据协议，奥赛康药业将获得Propella旗下用于骨关节炎疼痛治疗产品CGS-200-5在大中华区域的独家开发、注册、生产和商业化权利。奥赛康药业将支付Propella预付款，行政监管/商业里程碑式付款以及基于产品未来销售额的特许权使用费。CGS-200-5是一种局部用高浓度辣椒素制剂，用于治疗骨关节炎疼痛，在美国已完成II期临床研究。箕星药业获得LENZ老视治疗药物大中华区独家权利■  许可方：LENZ Therapeutics■  被许可方：箕星药业■  产品/技术：LNZ100和LNZ101箕星药业与美国生物制药公司LENZ Therapeutics签订许可协议，获得在大中华区开发和商业化其针对老视治疗的LNZ100（乙酰克里定）和LNZ101（乙酰克里定+溴莫尼定）的独家权利。LENZ将收到1500万美元预付款，并可能收到高达9500万美元额外付款，具体取决于开发、获批和商业化里程碑进展以及基于未来净销售额的特许权使用费。此外，箕星药业将向LENZ投资1000万美元。 两种产品均在进行II期临床试验，LENZ计划于2022年下半年开展III期临床试验。 京新药业与Evotec签署协议，拓展EVT201全球授权范围■  许可方：Evotec■  被许可方：京新药业■  产品/技术：安达西尼浙江京新药业股份有限公司与德国Evotec SE签署协议，双方就公司从Evotec获得新药EVT201独家授权的区域，从中国拓展到韩国以及全球其他国家，达成新的合作。EVT201是治疗成人失眠症的1类小分子新药，京新药业在国内已完成临床III期试验，并达到主要终点和次要终点。亚宝药业将引进印度鲁宾制药多种儿科产品■  许可方：印度鲁宾有限公司■  被许可方：亚宝药业■  产品/技术：未公布亚宝药业与印度鲁宾制药公司宣布双方将就中国区儿科产品展开深入合作。亚宝药业将引进多种儿科产品，以满足中国市场日益增长的儿科用药需求。亚宝一直着力打造儿童健康品牌，形成了以‘丁桂’品牌为龙头的儿科系列产品，在儿科产品市场处于领先地位。此次与鲁宾制药联手，将进一步补充国内儿科药品目录。美国Arrowhead与维梧资本设立中国合资公司，新公司获4款RNAi药物独家权利■  许可方：Arrowhead Pharmaceuticals, Inc.■  被许可方：Visirna Therapeutics■  产品/技术：四种RNAi治疗药物美国生物技术公司Arrowhead Pharmaceuticals与维梧资本在上海成立了一家合资企业Visirna Therapeutics。维梧资本向合资公司提供了6000万美元的初始资金，Arrowhead持有该合资公司大部分股权。同时，Arrowhead还与Visirna达成一项许可协议，Visirna将拥有在中国大陆、香港、澳门和台湾开发和商业化Arrowhead旗下用于心脏代谢疾病的四种研究性RNA干扰（RNAi）治疗药物的独家权利。Arrowhead将获得基于未来净销售额的特许权使用费，维梧资本将利用其在大中华区的网络，为Visirna招募领导团队。兆科眼科获得Visus公司两款药物权益■  许可方：Visus Therapeutics, Inc.■  被许可方：兆科眼科■  产品/技术：BRIMOCHOL PF及Carbachol PF兆科眼科与Visus Therapeutics, Inc.达成独家许可协议，以于大中华区、南韩及指定东南亚地区开发及商业化BRIMOCHOL PF及Carbachol PF。兆科眼科将支付预付款1500万美元，和最高1.15亿美元的监管、商业化及销售里程碑付款。 箕星药业获得Hovione临床前眼科新药JX08全球权利■  许可方：Hovione Limited■  被许可方：箕星药业■  产品/技术：JX08喷雾干燥领域的领先者Hovione宣布与箕星药业就临床前阶段的眼科项目JX08达成独家许可协议。箕星将获得JX08的全球权利，并领导从临床前到商业化阶段的全生命周期开发。更多产品和交易细节并未披露。 贝达药业获眼科新药EYP-1901中国区域独家开发和商业化权利■  许可方：Eyepoint Pharmaceuticals, Inc.■  被许可方：贝达药业■  产品/技术：EYP-1901贝达药业与EyePoint Pharmaceuticals, Inc.签署《扩大许可协议》，贝达药业取得在中国（包括香港、澳门和台湾）区域开发和商业化EYP-1901的独家权利，EyePoint保留EYP-1901在全球其他地区的眼科适应证权利。翰森制药获NiKang肿瘤药中国权益■  许可方： NiKang Therapeutics, Inc.■  被许可方：翰森制药■  产品/技术：NKT2152翰森制药与NiKang Therapeutics Inc.订立独家许可协议，获得后者NKT2152在中国（包括香港、澳门、台湾）用于肿瘤治疗的开发及商业化权益。翰森制药将负责NKT2152于中国的开发、注册审批及商业化，并将支付1500万美元首付款及最多2.03亿美元的开发、注册及基于销售的商业化里程碑潜在付款，以及基于净销售额的分级特许权使用费。NKT2152是一种抑制HIF-2α的小分子，目前正开展1/2期剂量递增及扩展试验。智飞绿竹与Intravacc公司就新型百日咳疫苗开发达成合作■  许可方：Inc.Intravacc公司■  被许可方：智飞绿竹■  产品/技术：Avacc 3荷兰Intravacc公司宣布与北京智飞绿竹生物制药有限公司签署《疫苗开发和许可协议》，双方将合作开发基于Intravacc公司疫苗专利技术生产的新型百日咳疫苗。智飞绿竹将负责目标疫苗在约定区域内（包括中国，非洲，南美，以及特定亚洲国家）的工艺研究、动物安评，临床试验和商业化销售。 正大天晴收购施维雅旗下LAG3单抗Sym022■  许可方：Symphogen A/S■  被许可方：正大天晴药业集团股份有限公司■  产品/技术：Sym022 中国生物制药有限公司宣布，附属公司正大天晴药业集团股份有限公司与Symphogen A/S签订协议，收购LAG3单克隆抗体Sym022。该交易涉及销售相关的潜在里程碑付款，具体细节未公布。Sym022是全人源重组的LAG-3单克隆抗体，目前已完成两项I期临床实验，结果显示其不论是作为单独用药或者是联合其他肿瘤免疫检查点抑制剂用药，都具有良好的安全性和耐受性。 复星医药获VerImmune肿瘤免疫药物大中华区权益■  许可方：VerImmune■  被许可方：复星集团■  产品/技术：VERI-101上海复星医药（集团）股份有限公司宣布，旗下位于美国的控股子公司Fosun Pharma USA和VerImmune签订《独家许可及选择协议》， Fosun Pharma USA 获VerImmune许可在大中华区（中国大陆及港澳台地区），针对治疗、缓解、诊断或预防人类或动物疾病领域独家临床开发、进口及商业化VERI-101。根据协议，VerImmune将获得至多总计1.25亿美元的首付款及里程碑款项，以及根据许可产品于区域内的年度净销售额达成情况、按约定比例区间（3%至10%不等）的销售提成。此外，VerImmune就VERI-102、VERI-103、VERI-104、VERI-105及其它同系列产品授予Fosun Pharma USA独家选择权。东诚药业获ImaginAb免疫细胞示踪剂中国大陆及港澳权益■  许可方：ImaginAb, Inc.■  被许可方：烟台东诚药业集团股份有限公司■  产品/技术：zirconium Zr 89 crefmirlimab berdoxam烟台东诚药业集团股份有限公司全资子公司南京江原安迪科正电子研究发展有限公司与ImaginAb, Inc.成合作。安迪科为独家经销商，将取得ImaginAb旗下zirconium Zr 89 crefmirlimab berdoxam产品专利权下规定的权利及相关数据，进而在中国大陆、香港及澳门特别行政区开展该授权产品的开发、注册、制造和销售。安迪科将在签署协议后向ImaginAb支付预付款，并在达到注册路径确认、目标产品IND获批、目标产品BLA获批等里程碑节点时支付后续相关费用；并按照累计净销售额的固定比例进行分成。凯信远达与天石同达医药共同开发CD38单抗■  许可方：凯信远达医药有限公司■  被许可方：北京天石同达医药科技有限公司■  产品/技术：CID-103凯信远达医药（中国）有限公司宣布与北京天石同达医药科技有限公司签订了一份分许可协议。根据协议，天石同达医药将获得凯信远达抗CD38抗体CID-103的全球许可。凯信远达将收到1000万美元的预付款、里程碑付款以及基于未来销售额的特许权使用费。此外，凯信远达将保留CID-103在自身免疫适应证方面的独家商业化和联合营销权，并获得在美国市场的全部收入，还可以选择在中国市场共同商业化自身免疫性疾病血液学和肿瘤适应证。华润双鹤获Ligand口服新冠候选药亚洲权益■  许可方：Ligand Pharmaceuticals Inc.■  被许可方：华润双鹤药业股份有限公司■  产品/技术：LGN-20华润双鹤药业股份有限公司发布公告称，拟通过创新事业部以不超过2,075万美元从美国Ligand Pharmaceuticals Incorporated.获得口服新冠候选药物LGN-20在亚洲区域内（除以色列、俄罗斯、土耳其）独占开发、生产及商业化权益，以及在产品获得批准后相关专利的转让。授权交易License-out阿斯利康获得和铂医药双抗HBM7022全球独家权益■  许可方：和铂医药■  被许可方：阿斯利康■  产品/技术：HBM7022和铂医药宣布，与阿斯利康就CLDN18.2xCD3双特异性抗体HBM7022的开发与商业化达成全球对外授权协议。阿斯利康将获得HBM7022的研究、开发、注册、生产和商业化的全球独家许可，并负责HBM7022临床前的进一步开发及商业化相关所有费用。和铂医药将获得2500万美元预付款和最高达3.25亿美元里程碑付款，以及基于未来HBM7022销售额特许权使用费。 普瑞金生物授予CellPoint靶向BCMA的CAR-T疗法欧美权益■  许可方：普瑞金生物■  被许可方：CellPoint B.V.■  产品/技术：靶向BCMA嵌合抗原受体T细胞深圳普瑞金生物药业有限公司与荷兰公司CellPoint 宣布达成授权合作。CellPoint公司将获得普瑞金自主开发的PRG-1801（靶向BCMA的嵌合抗原受体T细胞注射液）用于血液肿瘤适应证的欧美权益，并负责该产品在欧美地区的临床开发和商业化。普瑞金将获得超过2000万欧元的首付款，以及后续相应阶段里程碑付款和超过10%的商业化销售提成。此外，普瑞金将为其供应慢病毒载体。PRG-1801是普瑞金自主开发的靶向BCMA的CAR-T细胞药物，用于治疗复发/难治性多发性骨髓瘤。亿帆医药授予APOGEPHA在研产品F-627瑞士经销权■  许可方：亿帆医药■  被许可方：Apogepha Arzneimittel GmbH■  产品/技术：艾贝格司亭α亿帆医药发布公告称旗下子公司爱尔兰亿一（Evive Biotech）将在研产品艾贝格司亭α注射液液（曾用通用名：重组人粒细胞集落刺激因子-Fc融合蛋白，拟用商品名：亿立舒，研发代号：F-627）在瑞士的独家经销权许可给APOGEPHA公司。APOGEPHA向爱尔兰亿一支付最高额不超过697.5万美元的首付款、 法规、开发及销售里程碑付款。F-627是基于亿一生物自主知识产权的Di-KineTM双分子技术平台开发的创新生物药品种，目前已在多个市场提交上市申请。复宏汉霖授予Eurofarma三款生物类似药南美权益■  许可方：复宏汉霖■  被许可方：GmbHEurofarma Laboratorios S.A.■  产品/技术：汉利康、汉曲优、汉贝泰复宏汉霖与Eurofarma Laboratorios S.A.（Eurofarma）订立一份许可协议，授予后者汉利康（利妥昔单抗注射液）、汉曲优（注射用曲妥珠单抗；欧盟商品名：Zercepac）及汉贝泰（贝伐珠单抗注射液）在许可区域肿瘤治疗领域的独家和半独家开发、生产和商业化权益。Eurofarma将向复宏汉霖支付450万美元首付款、每个产品300万美元监管里程碑付款和每个产品4300万美元的商业销售里程碑付款，共计1.425亿美元。礼新医药授予Turning Point创新抗体偶联药物海外权益■  许可方：礼新医药■  被许可方：Turning Point■  产品/技术：LM-302礼新医药与美国肿瘤精准疗法公司Turning Point针对Claudin 18.2创新抗体偶联药物LM-302达成海外独家授权合作。根据协议，Turning Point将向礼新医药支付2500万美元首付款，以获取LM-302在全球除大中华区与韩国以外国家及地区的独家开发和商业化权益。礼新医药将有资格获得包括研发里程碑1.95亿美元在内的最高达10亿美元的里程碑付款，并在LM-302成功商业化后有权从Turning Point区域净销售额中获得个位数到两位数百分比的梯度特许权使用费。默沙东获科伦药业项目A中国外商业化开发权■  许可方：四川科伦药业股份有限公司■  被许可方：默沙东■  产品/技术：未具体公布四川科伦药业股份有限公司发布公告称，子公司科伦博泰已与MERCK SHARP&DOHME CORP.（下称“默沙东”）签署许可协议修正案，科伦博泰将其具有自主知识产权的生物大分子肿瘤项目A有偿独家许可给默沙东进行中国以外（中国包括中国大陆，香港、澳门和台湾）区域范围内的商业化开发。默沙东将根据商业化开发阶段向科伦博泰支付首付款、各类里程碑付款及相应净销售额提成。科伦博泰于许可协议生效时收到1700万美元一次性、不可退还的付款，于本协议修正案签署后收到3000万美元一次性、不可退还的付款，里程碑付款累计不超过13.63亿美元，并按双方约定的净销售额比例提成。此次协议未说明具体产品。复宏汉霖授予Abbott汉利康、汉曲优巴西权益■  许可方：上海复宏汉霖生物技术股份有限公司■  被许可方：雅培公司■  产品/技术：利妥昔单抗、曲妥珠单抗上海复宏汉霖生物技术股份有限公司发布公告称，其已与Abbott Operations Uruguay S.R.L.订立一份产品许可协议，同意授予Abbott在巴西联邦共和国内内对进行商业化的半独家许可，以及作为备用生产商或委托备用生产商生产许可产品的非独家许可。根据协议，Abbott将向复宏汉霖支付300万美元首付款，以及合计不超过140万美元的监管里程碑付款。协议初始期限为产品在许可地区内商业化上市起10年，届满后会自动续期5年。 扫描左侧二维码，登录GBI SOURCE全球药品数据库，点击交易版块了解更多信息。 （本文授权转自：GBIHealth）版权声明/免责声明本文为转载内容，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读聊聊恒瑞——从恒瑞向左股价向右，到中国制药一哥大胆向前走！。。。【药时代恒瑞系列】高票通过！FDA专家咨询委员会首日，蓝鸟生物「闯关成功」，这次他们能缓过来吗？美国也有「药价难」，13年间新药价格翻了90倍，哈佛教授：我们要学习别国的药价谈判政策...辉瑞CDK 4/6重磅产品3期临床试验「结果令人失望」，诺华、礼来和恒瑞的机会来了？我们的历史不是我们的命运！！当拥有5000年历史的「乳腺癌」，碰到了109岁的「魔法子弹」ASCO速递：原启生物口头报告Ori-CAR017 I 期临床研究（POLARIS）数据【百期直播特别活动】美国处方药的定价与报销 | 药时代直播间第104期、105期41亿美元！百时美施贵宝收购华人科学家创办的Turning Point Therapeutics才华出众，气质超群！这些中国医药界「女神」上榜「2022福布斯中国科技女性50」大话ADC——爆款、热点和未来！| 「国际CMO学苑」第4期活动寒冬之下，逆势前行！2021年度中国最佳「生物医药领域投资案例」TOP10出炉，这些公司有何特别之处？生物经济来临，如何应对挑战，穿越AI制药产业新周期？受美国预摘牌影响的14家中国药企之股价、市值分析 | 药时代出海系列中国新药出海，传奇再现！全球新，中国创！本维莫德终获FDA批准！恒瑞喜讯频传！。。。| 药时代出海系列2022 ASCO 各领域口头报告一览（附：731页ASCO 会议摘要）【诚聘付费专家】电话咨询主题：抑郁症、肺鳞癌、黑色素瘤、糖尿病、肥胖新药研发之竞争格局与潜在机遇Fierce Biotech裁员盘点：生物技术行业正向着“小而精”的趋势发展药时代BD项目 | 高亲和力、高效能CD24靶向单克隆抗体斑秃患者的福音！JAK抑制剂CTP-543的III期临床试验取得阳性结果！维昇药业首个关键3期临床试验达到主要终点点击这里，欢聚药时代！