On August 24, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the 2022 Interim Results (Press release, Carsgen Therapeutics, AUG 24, 2022, View Source [SID1234618624]).

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Business Highlights

CARsgen’s pipeline
CARsgen’s pipeline
CT053: completed enrollment for pivotal Phase II trial in China, with plan to submit the NDA to the NMPA in the third quarter of 2022
CT041: initiated a confirmatory Phase II clinical trial in China
CT041: was granted RMAT by the FDA
CT041: data from a China Investigator-Initiated Trial was published in Nature Medicine
Continuous development of innovative CAR T technologies to empower the next generation pipeline products
U.S. CGMP manufacturing facility began operations, with plan to support clinical trials in North America from second half 2022
Appointed CARsgen CMO and CARsgen US President
Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said that "In the first half of 2022, CARsgen has made significant progresses in advancing our technology innovations, product pipeline, and business operations in the U.S. and China, despite the impact of the COVID-19 pandemic. CT041 has become the world’s first and the only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial. For CT053, we plan to submit the NDA to the NMPA in the third quarter of 2022. Our U.S. CGMP manufacturing facility has also started operations. We continue to dedicate ourselves to advancing innovative CAR T technologies to address the major challenges of the industry. We have also established in-house, vertically integrated manufacturing capabilities. Driven by the vision of Making Cancer Curable, we expect to bring innovative and differentiated cell therapy to cancer patients around the world as soon as possible, creating value for investors and the public."

1. Steady development of product pipeline with leadership position in CAR T cell against solid tumors

CT053

CT053 is an upgraded fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. It incorporates a CAR construct with a fully human BCMA-specific single-chain variable fragment (scFv) with lower immunogenicity and increased stability, which overcomes the challenge of T-cell exhaustion by reducing the self-activation of CAR T cells in the absence of tumor-associated targets.

CT053 received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations for the treatment of R/R MM from the U.S. FDA in 2019, PRIority Medicines (PRIME) eligibility in 2019 and Orphan Medicinal Product designation in 2020 for the treatment of R/R MM from the European Medicines Agency (EMA), and Breakthrough Therapy designation for the treatment of R/R MM from the NMPA in 2020.

CARsgen has completed the patient enrollment of the pivotal Phase II trial patients in China (LUMMICAR STUDY 1) and plans to submit the NDA to the NMPA in the third quarter of 2022. CARsgen is conducting the pivotal Phase 2 trial in North America (LUMMICAR STUDY 2), and the Company plans to submit the BLA to the U.S. FDA in the end of 2023. The Company also plans to conduct additional clinical trials to develop CT053 as an earlier line of treatment for multiple myeloma.

An update from the China investigator-initiated trials (IITs) was published in Haematologica in 2022.

CT041

CT041 is an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2) and has the potential to be first-in-class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and PC. CARsgen was the first in the world to successfully identify, validate and report CLDN18.2 as a solid tumor-associated antigen and viable target for CAR T-cell therapy for solid tumors in which CLDN18.2 is prevalently or highly expressed.

CT041 received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer. CT041 was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in 2021 and was granted RMAT Designation for the treatment of advanced GC/GEJ with CLDN18.2-positive tumors in 2022.

As of the date of the announcement, CT041 is the world’s first and the only CAR T-cell candidate for the treatment of solid tumors entering a confirmatory Phase II clinical trial.

Active trials in CARsgen include a Phase 1b/2 clinical trial for advanced GC/GEJ and PC in North America (CT041-ST-02, NCT04404595), a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), and IITs. CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024. CT041 have now completed the dose escalation and initiated the dose expansion in U.S. CARsgen also plans to initiate a Phase 2 clinical trial in the second half of 2022 in North America and to submit the BLA to the U.S. FDA in 2024.

Updates from the Phase 1b study in the U.S. (NCT04404595) and the Phase Ib/II study in China (NCT04581473) were provided in poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. An update from a China IIT was published in Nature Medicine in May 2022, which is the largest clinical trial for CAR T-cell therapy in solid tumors to date.

AB011

AB011 is a humanized monoclonal antibody product candidate against CLDN18.2 for the treatment of CLDN18.2-positive solid tumors. The company obtained the second investigational new drug (IND) clearance in the world for a mAb targeting CLDN18.2.

CARsgen has completed Phase I monotherapy cohort enrollment and initiated a trial for combination with chemotherapy.

2. Continuous discovery and technology development

CARsgen has established an integrated research and development platform covering the full CAR T development cycle including target discovery, antibody development, vector design, manufacturing, quality assurance, and quality control. CARsgen continues to dedicate itself to advancing innovative CAR T technologies to address the major challenges of the industry. The four strategic pillars include:

（1） Efficacy: To enhance efficacy against solid tumors, CARsgen continues to develop next generation CAR T technologies, such as CycloCAR. CycloCAR features the co-expression of cytokine IL-7 and chemokine CCL21 in CAR T cells to potentially improve clinical efficacy and reduce the requirement of lymphodepletion conditioning.

（2） Safety: To improve the applicability of adoptive cell therapies, CARsgen developed the sFv-ε-based T-cell therapy powered by a full T-cell receptor (TCR) complex comprising a GPC3-targeted scFv and a CD3ε subunit, which can form a functional TCR complex with other TCR subunits and redirect T cells to kill tumor cells in an MHC-independent manner.

（3） Patient accessibility: CARsgen is developing allogeneic CAR T-cell product candidates using THANK-uCAR technology, which it believes could potentially increase CAR T cell expansion, persistence, and efficacy. CARsgen believes the successful application of THANK-uCAR technology would significantly lower the cost of CAR T-cell therapy and increase patient accessibility.

（4） Target availability: CARsgen developed LADAR technology (local action driven by artificial receptor), in which an artificial receptor is triggered by a LADAR Ligand to induce the transcription of the gene(s) of interest. Through the LADAR artificial receptor, the antitumor CAR transcription is only triggered when the LADAR binds to a LADAR Ligand, making it possible to precisely control when and where immune cells act against cancer cells.

These technologies are currently being developed in-house with global rights and can be used alone or in combination to upgrade CARsgen’s existing product candidates and to generate future pipeline product candidates.

As of June 30, 2022, CARsgen had more than 300 patents of which 70 patents had been issued globally including China, the United States, Europe, and Japan. This is an increase of 7 issued patents and 21 patent applications from the end of 2021.

3. Vertically integrated manufacturing capabilities, supporting clinical trials globally

CARsgen has established in-house, vertically integrated manufacturing capabilities, including the production of plasmids, lentiviral vectors, and CAR T cells.

CARsgen has been expanding its global manufacturing capacity in China and the U.S. to support both clinical trials and the subsequent commercialization of pipeline products. With the clinical manufacturing facility in Xuhui, Shanghai and commercial GMP manufacturing facility in Jinshan, Shanghai, CARsgen manufactures CAR T-cell products in-house to support clinical trials in China and manufacture the lentiviral vectors in-house to support clinical trials globally.

In 2021, CARsgen has made significant progress in expanding CARsgen’s manufacturing capacity outside China by launching a state-of-the-art GMP Manufacturing Facility in Research Triangle Park, Durham, North Carolina. CARsgen successfully passed the official inspections and received the Certificate of Compliance from the City-County Inspections Department of Durham. CARsgen has commenced commissioning, qualification, and validation of RTP Manufacturing Facility through the RMAT consultation with the FDA. Concurrently, CARsgen has been executing the technology transfer to RTP Manufacturing Facility, advancing to the clinical manufacturing of CT041 and CT053 products.

4. Strengthened leadership team with rich experience

As of June 30, 2022, CARsgen had a total of 601 employees. The company has also strengthened the leadership team: CARsgen hired Dr. Raffaele Baffa as the Chief Medical Officer of the Company, and Mr. Richard Daly as the President of CARsgen Therapeutics Corporation. Biographical details of the senior management team are provided on the company’s website at www.CARsgen.com.

On August 24, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported its interim results for first half of 2022 along with a corporate progress update (Press release, Everest Medicines, AUG 24, 2022, View Source [SID1234618623]).

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Everest has made significant progress on all fronts of our business and therapeutic areas in the first half of 2022 as the company continued to progress clinical and regulatory development across our diverse pipeline, build up self-discovery capabilities and expand key partnerships. Looking ahead, by strengthening our capital structure through the recent strategic sale of the rights to Trodelvy in Asia territories, Everest has the capacity to accelerate the development of important assets in our portfolio with first-in-class or best-in-class potential, further advance our internal discovery efforts and pursue business development opportunities that will maximize impact for patients worldwide and create sustained, long-term value for our shareholders. Below are product highlights in 1H and anticipated future milestones:

NEFECON (TarpeyoTM), a novel oral formulation of budesonide (budesonide delayed release capsules) in the development for the treatment of primary immunoglobulin A nephropathy (IgAN).

– Product development achievements during the Reporting Period:

In March 2022, the Company announced it entered into a license agreement with Calliditas to develop and commercialize NEFECON for the treatment of primary IgAN in South Korea, expanding its license in addition to rights held in Greater China and Singapore. The deal signaled the Company’s latest efforts to further enhance its international commercial footprint.
In April 2022, the Company announced the findings of reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after nine months of treatment with NEFECON are in line with topline results from Part A of the pivotal global Phase 3 clinical trial NefIgArd, which were reported in November 2020 by our partner, Calliditas Therapeutics.
– Post-Reporting Period achievements and expected milestones:

In July 2022, our partner Calliditas was granted conditional marketing authorization for Kinpeygo (developed under the name NEFECON) by the European Commission for the treatment of IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/gram.
We expect to file a New Drug Application (NDA) for NEFECON in China in the second half of 2022.
Etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC).

– Product development achievements during the Reporting Period:

In May 2022, our licensing partner, Pfizer Inc., presented detailed results from two pivotal studies that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod for the treatment of moderately-to-severely active UC. Both Phase 3, multi-center, randomized, placebo-controlled trials achieved all primary and key secondary endpoints, with etrasimod demonstrating a safety profile consistent with previous studies. In the 52-week ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P=<.001) and was 32.1% compared with 6.7% at week 52 (25.4% differential, P=<.001). In the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients receiving etrasimod compared with 15.2% of patients receiving placebo (9.7% differential, P=.0264). The data from ELEVATE UC 52 & UC 12 are expected to form the basis for planned future regulatory filings, which Pfizer expects to initiate later this year.
– Post-Reporting Period achievements and expected milestones:

We are conducting a Phase 3 study for etrasimod for the treatment of moderate-severe UC, which is expected to complete enrollment in 2023.
PTX-COVID19-B, a potentially best-in-class lipid nanoparticle-formulated mRNA COVID-19 vaccine with strong immunogenicity and tolerability profiles.

– Product development achievements during the Reporting Period:

In April 2022, the Company announced it entered into a memorandum of understanding (MOU) for a partnership with China Resources Pharmaceutical Group Limited with the intention to establish an independent company ("the mRNA Co.") focused on the discovery, development and commercialization of messenger RNA (mRNA) vaccines. Through this proposed partnership with CR Pharma, the mRNA Co. will be well-positioned to advance its potentially best-in-class mRNA vaccine candidates through Chinese regulatory pathways and into commercialization. Under the terms of the MOU, the mRNA Co. will be a fully functional, independent operating company by assuming the rights under the existing collaboration with Providence Therapeutics Holdings Inc., including the full technology platform, as well as the Company’s mRNA manufacturing infrastructure. The Company will be the majority and controlling shareholder of the mRNA Co.
– Post- Reporting Period achievements and expected milestones:

Providence will readout the data from the pivotal Phase 2 trial of PTX-COVID19-B in 2022.
Providence and the Company will initiate a Phase 3 trial of PTX-COVID19-B for booster indication in 2022.
Providence and the Company are working on an Omicron-containing bivalent booster candidate, EVER-COVID19-M1, and expect to file investigational new drug application (IND) for phase 3 registrational study in the first half of 2023.
Providence and the Company expect rolling regulatory submissions of our mRNA COVID-19 vaccines starting in 2023 globally and anticipate approval and launch in 2023.
Sacituzumab govitecan (Trodelvy), a first-in-class TROP-2 directed antibody-drug conjugate (ADC).

– Product development achievements during the Reporting Period:

In January 2022, the Company announced it would participate in a study pursuant to a clinical trial collaboration between Gilead Sciences, Inc. ("Gilead") and Merck & Co., Inc. ("MSD") to evaluate the combination of sacituzumab govitecan and MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) in first-line metastatic non-small cell lung cancer ("NSCLC"). As part of the collaboration, MSD will sponsor this trial. The Company will participate in the global phase 3 study in Asia through its existing collaboration agreement with Gilead.
In January 2022, the Health Sciences Authority ("HSA") of Singapore approved the Company’s New Drug Application ("NDA") for sacituzumab govitecan for the treatment of second-line and later lines metastatic triple negative breast cancer ("TNBC").
In March 2022, the Company submitted an NDA to the Department of Health of Hong Kong for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC.
In June 2022, our partner Gilead reported positive results from the primary analysis of phase 3 TROPiCS-02 study of Trodelvy (sacituzumab govitecan) versus physician’s choice of chemotherapy ("TPC") in heavily pre-treated hormone receptor positive, HER2 negative metastatic breast cancer ("HR+/HER2- mBC") patients who received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy. The study met its primary endpoint of progression-free survival ("PFS") with a statistically significant 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53–0.83; P<0.0003).
In June 2022, the Company announced that the China National Medical Products Administration ("NMPA") had approved Trodelvy for the treatment of adult patients with second-line metastatic TNBC. This represents the first drug that the Company has obtained an NDA approval to launch in China, and it follows the NMPA’s acceptance of the Company’s NDA for Trodelvy with Priority Review designation in May 2021.
– Post- Reporting Period achievements:

In August 2022, the Company announced it entered into an agreement with Immunomedics, Inc., ("Immunomedics"), a wholly-owned subsidiary of Gilead Sciences, Inc., whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia (the "Agreement"). Under the terms of the Agreement, the Company will receive up to $455 million in total considerations with $280 million in upfront payments payable subject to, among other things, certain regulatory approvals and up to $175 million in potential future milestone payments. In addition, Everest will be released from payment obligations for up to $710 million in remaining milestone payments under a licensing agreement entered into with Immunomedics in April 2019 to develop, register, and commercialize Trodelvy in Greater China, South Korea and certain other countries and territories. Under the Agreement, the licensing agreement will be terminated.
The TRODELVY trademark is used under license from Gilead Sciences, Inc.
Other clinical-stage assets

– Product development achievements during the Reporting Period:

In March 2022, our licensing partner, Venatorx Pharmaceuticals ("Venatorx"), reported positive results from its pivotal Phase 3 study, CERTAIN-1, evaluating cefepime-taniborbactam, an investigational new drug, versus meropenem as a potential treatment for hospitalized adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The CERTAIN-1 trial enrolled 661 adult patients globally, including in China, who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for seven days (up to 14 days for patients with bacteremia). Cefepime-taniborbactam met the primary efficacy endpoint of statistical non-inferiority (NI) to meropenem in the microbiological intent-to-treat (microITT) population at Test of Cure (TOC) with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% CI, 2.4, 21.6). Venatorx plans to submit an NDA with the U.S. FDA for cefepime-taniborbactam for the treatment of cUTI in hospitalized adult patients later this year.
Ralinepag is a next-generation, potent, selective oral IP receptor agonist being developed for the treatment of pulmonary arterial hypertension (PAH). We continue to progress our Phase 3 registrational trial for PAH in China as part of a global Phase 3 study conducted together with our partner, United Therapeutics.
– Post- Reporting Period achievements and expected milestones:

In August 2022, the Company announced that the Taiwan Food and Drug Administration (TFDA) accepted the submission of an NDA for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). In addition, the Company entered into an exclusive partnership agreement with TTY Biopharm for the commercialization of Xerava in Taiwan.
We expect NDA approval for eravacycline for the treatment of cIAI in China within 2022.
Business Development Updates

In January 2022, the Company entered into a global licensing agreement with Singapore’s national platform for drug discovery and development, the Experimental Drug Development Centre ("EDDC"), for the exclusive worldwide rights to develop, manufacture and commercialize EDDC’s series of viral 3C-like (3CL) protease inhibitors as a potentially best-in-class oral antiviral treatment against SAR-CoV-2 (the virus causing COVID-19) and its variants. The Company has full rights to sub-license the drug further and will receive full technology transfer.
We expect Phase 1 clinical trials of EDDC-2214, as an oral antiviral treatment against SAR-CoV-2 and its variants, to begin in 2023.
Discovery Updates:

In Feb. 2022, the Company officially launched its first research center for innovative drugs in Shanghai’s Zhangjiang Hi-Tech Park, and has initiated more than 10 discovery projects across multiple therapeutic areas, such as oncology, renal disease and mRNA vaccine.
We expect some of the discovery projects to advance to IND filing in 2023.
Commercialization:

We have built up an industry-leading commercial team with an extensive track record of successfully commercializing novel therapies across a range of therapeutical areas to support our anticipated commercial launch of multiple late-stage products. Our commercial team has been conducting key opinion leaders (KOL) engagements and medical education activities about IgAN and cIAI.
Financial Highlights

IFRS Numbers:

Research and development ("R&D") expenses increased by RMB94.7 million from RMB250.8 million for the six months ended 30 June 2021 to RMB345.5 million for the six months ended 30 June 2022, primarily due to (i) additional clinical trials for our drug candidates; (ii) expansion of internal discovery team to build up in-house R&D capabilities; (iii) increased technical transfer related costs for our drug candidates.
General and administrative expenses increased by RMB11.5 million from RMB107.4 million for the six months ended 30 June 2021 to RMB118.9 million for the six months ended 30 June 2022, mainly due to increased office expenses and other infrastructure expenses to support expanded organization.
Distribution and selling expenses increased by RMB106.1 million from RMB42.1 million for the six months ended 30 June 2021 to RMB148.2 million for the six months ended 30 June 2022, primarily due to the expansion of our commercial organization and launch and pre-launch activities carried out for product commercialization.
Net loss for the period increased by RMB284.9 million from RMB383.1 million for the six months ended 30 June 2021 to RMB668.0 million for the six months ended 30 June 2022, primarily attributable to increased R&D expenses and distribution and selling expenses.
Cash and cash equivalents amounted to RMB1,956.8 million as of 30 June 2022.
Non-IFRS Measure:

Adjusted loss for the period[i] increased by RMB220.6 million from RMB303.1 million for the six months ended 30 June 2021 to RMB523.7 million for the six months ended 30 June 2022, primarily attributable to an increase in R&D expenses and distribution and selling expenses.
[i] Adjusted loss for the period represents the loss for the period attributable to the equity holders of the Company excluding the effect of certain non-cash items and one-time events, namely the loss on fair value changes of preferred shares (non-current financial liabilities measured at fair value through profit or loss) and share-based compensation loss.

On August 24, 2022 Nordic Nanovector ASA (OSE: NANOV) reported that it will report its results for the second quarter and first half 2022 on Wednesday, 31 August 2022 (Press release, Nordic Nanovector, AUG 24, 2022, View Source [SID1234618622]).

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A presentation by Nordic Nanovector’s senior management team will be held in-person and webcast live beginning at 8:30am CEST.

Venue: Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2022 from 7:00am CEST the same day.

On August 24, 2022 Alpha Biopharma, a developer of innovative drugs, reported the completion of last patient last visit (LPLV) in its international, multicenter EVEREST phase II/III clinical study of Zorifertinib, a next-generation EGFR-TKI, in first line patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases (Press release, Alpha Biopharma, AUG 24, 2022, View Source [SID1234618621]). Topline data from this MRCT study are expected around the end of 2022, at which time Alpha Biopharma could submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA).

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As the international leading principal investigator (PI) of EVEREST study, Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG), said: "EVEREST study is an international, multicenter, phase II/III randomized clinical study. It is also the only large-scale prospective international multicenter clinical study worldwide for first line EGFRm+ NSCLC patients with CNS metastases to date. It was carried out in 55 study sites located in Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The clinical and preclinical data of Zorifertinib have shown its high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and similar safety profile as other EGFR-TKI drugs. If approved, it is expected to provide a valuable choice for treatment of EGFRm+ NSCLC patients with CNS metastases. As the name EVEREST suggests, the study sponsor and investigators are dedicated to solving important unmet clinical needs."

Professor Jie Wang, Director of Oncology Department of Cancer Hospital Chinese Academy of Medical Sciences, and co-leading PI of EVEREST study, said: "Lung cancer with CNS metastases has always been a challenging problem and leading cause of death for these patients. Zorifertinib is a next-generation, high-potent EGFR-TKI drug targeting sensitive mutations of exon 19 deletion or L858R in EGFR gene with good exposure in CNS lesions. It is not a substrate of efflux transporter P-gp and BCRP, thus not only capable of fully passing through BBB, but also maintaining high drug exposure in the brain tissue and cerebrospinal fluid. It was intentionally designed to optimize its physicochemical and biochemical properties meet the requirements of CNS penetration, which has been proven to be the case in this and prior clinical studies. We look forward to the finale data readout and if positive, a direly needed treatment for these patients."

Dr. Ruilin Song, Executive President of China Pharmaceutical Innovation and Research Development Association, said: "In the past three years, the COVID-19 pandemic in some regions of China has brought great challenges to innovative biotech companies. Many clinical study sites faced challenges in terms of regional lockdown, logistics, and clinical operations. However, the clinical development team at Alpha Biopharma and investigators worked together to overcome difficulties to achieve the key milestones of the EVEREST study. They diligently communicated with study sites to come up with solutions, paid full attention to the safety of the subjects and the quality of the trial data while ensuring the uninterrupted treatment of the subjects. In recognizing this pivotal milestone of EVEREST study completion, we would like to express sincere respect for the efforts of all relevant personnel involved in the study and wish Zorifertinib a smooth NDA submission. We are a step closer to bringing new hope to patients with CNS metastases of EGFRm+ NSCLC."

About Zorifertinib

Zorifertinib is a potent, oral, reversible inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor (EGFR-TKI) activating mutation (L858R and Exon19Del). EGFR is widely expressed in human epidermal cells and stromal cells and is highly expressed in a variety of human malignancies, such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis. CNS metastases is common in EGFRm+ NSCLC patients and accompanied with poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a new-generation EGFR-TKI specifically designed to fully penetrate the BBB to target brain metastases. Zorifertinib is in late-stage clinical studies and has global intellectual property protection.

On August 24, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that management will participate in the following upcoming investor conferences (Press release, Galapagos, AUG 24, 2022, View Source [SID1234618620]):

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Citi’s 17th Annual Biopharma Conference. September 8, 2022 in Boston
Morgan Stanley 20th Global Healthcare Conference. September 12-14, 2022 in New York
Bank of America Merrill Lynch Global Healthcare Conference. September 15, 2022 in London
KBC Securities Virtual Life Sciences Conference. September 16, 2022
JP Morgan CEO Call Series. September 28, 2022
Credit Suisse 31st Annual Healthcare Conference. November 8-10, 2022 in Rancho Palos Verdes, CA
Bryan Garnier Virtual Conference on Cell Therapy Innovation. November 14, 2022
Jefferies 2022 Global Healthcare Conference. November 16-17, 2022 in London
Kepler Cheuvreux Virtual Life Science Days. November 21, 2022
Deutsche Bank 2022 Call Series. November 30, 2022

Additional information regarding these events will be available on the investor section of the Galapagos website at glpg.com/events.