Iovance Biotherapeutics Announces First Patient Dosed with PD-1 Inactivated Tumor Infiltrating Lymphocyte (TIL) Therapy

On October 10, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the first patient was dosed, and completed the safety observation period, in the IOV-GM1-201 trial of Iovance’s genetically modified, PD-1 inactivated TIL therapy, IOV-4001 (Press release, Iovance Biotherapeutics, OCT 10, 2022, View Source [SID1234621849]). IOV-GM1-201 is a Phase 1/2, first-in-human study investigating the safety and efficacy of IOV-4001 in patients with previously treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.

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Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers."

To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes the gene-editing TALEN technology licensed from Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies. This single genetic modification in IOV-4001 may enhance the antitumor activity of the TIL mechanism to directly target and kill tumor cells.

Jason Chesney, M.D., Ph.D., Director and Endowed Professor, UofL Health – Brown Cancer Center, University of Louisville, and an IOV-GM1-201 principal investigator, stated, "I am excited about the potential for gene-editing to open new doors for TIL therapy in patients with solid tumor cancers that do not respond well to current treatment options. As the first multicenter clinical trial to investigate a genetically modified TIL therapy, the IOV-GM1-201 trial may pave the way for a promising new treatment approach to cancer."

PD-1 is a checkpoint protein found on T cells that normally acts as an "off switch" to help to prevent T cells from attacking other cells in the body. It works by binding to PD-L1, a protein found on both normal and cancerous cells, thereby shutting down an attack by a T cell. As a TIL therapy that is genetically modified to remove this important barrier for T cells to attack cancer, IOV-4001 has the potential to become an optimized, next generation TIL therapy for several solid tumor cancers. A poster on preclinical data was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.

IOV-GM1-201 is actively enrolling adult participants with advanced NSCLC or unresectable or metastatic melanoma. For more information, eligibility criteria, and trial locations, please visit www.clinicaltrials.gov (NCT05361174) or contact [email protected].

Exact Sciences schedules third quarter 2022 earnings call

On October 10, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company plans to release its third quarter 2022 financial results after the close of the U.S. financial markets on November 3, 2022 (Press release, Exact Sciences, OCT 10, 2022, View Source [SID1234621845]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1 647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

Alligator Bioscience to Present at 10th Annual Immuno-Oncology Summit, October 12 -14, 2022

On October 10, 2022 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) reported that Mattias Levin, PhD, Sr Team Manager Antibody Engineering at Alligator Bioscience, will present at the 10th Annual Immuno-Oncology Summit being held in Boston and virtually, October 12-14 (Press release, Alligator Bioscience, OCT 10, 2022, View Source [SID1234621844]).

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Presentation Details:

Title: "Bispecific Tumor Antigen Conditional Agonistic Antibodies in Immuno-Oncology"
Date: Thursday 13 October 2022
Time: 10:30 am EDT / 4:30 pm CEST
The presentation will focus on Alligator’s Neo-X-Prime, a CD40-based bispecific platform with a dual mechanism of action that, in addition to CD40, targets tumor associated antigens (TAA) expressed at high densities. This enhances the uptake of tumor material by dendritic cells and increases effective neoantigen cross-priming of tumor specific T cells, resulting in increased anti-tumor efficacy. Neo-X-Prime bispecific antibodies address a key need in immune-oncology by increasing tumor specific T cells in the tumor microenvironment.

The presentation will highlight preclinical data and the medical opportunities in multiple cancer indications of ATOR-4066, Alligator’s preclinical first-in-class bispecific CD40 agonist.

Registration for the conference is open here.

The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on October 10, 2022.

The China NMPA Approved CYRAMZA® (ramucirumab) for the Treatment in Patients with Hepatocellular Carcinoma

On October 9, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, reported that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for CYRAMZA (ramucirumab) in patients with hepatocellular carcinoma (HCC, also known as liver cancer), who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib (Press release, Innovent Biologics, OCT 9, 2022, View Source [SID1234621843]). In March 2022, CYRAMZA (ramucirumab) was approved by the NMPA in combination with paclitaxel for second-line treatment in patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma, making it the first and only targeted drug approved for the second-line treatment of advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma in China.

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CYRAMZA (ramucirumab) has been discovered and developed by Lilly. In March 2022, Innovent and Lilly expanded their strategic partnership in oncology, which includes an agreement for Innovent to obtain the sole commercialization rights of CYRAMZA (ramucirumab) once approved in China, which positions Innovent to be fully responsible for the pricing, importation, marketing, distribution and detailing of this product. With this further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers and to provide integrated patient solutions with strong synergies to cancer patients in China.

This new approval was based on the results of the REACH-2 study[1],[2], a global randomized, double-blind, placebo-controlled Phase 3 clinical trial. The REACH-2 study is the first Phase 3 clinical trial in HCC to obtain positive results in a biomarker-enriched population known for poor prognosis. On the primary endpoint of overall survival (OS), treatment with CYRAMZA significantly improved the OS of patients compared to placebo (HR: 0.71; 95% CI: 0.53-0.95; P=0.020). The median OS was 8.5 months with CYRAMZA, compared to 7.3 months with placebo. On the secondary endpoint of progression-free survival (PFS), median PFS was significantly improved with CYRAMZA (2.8 months vs. 1.6 months for placebo (HR: 0.45; 95% CI: 0.34-0.60; P<0.0001)). Objective response rate (ORR) was numerically higher with CYRAMZA compared to placebo (4.6% vs. 1.1%). Disease control rate (DCR) was higher with CYRAMZA than with placebo (59.9% vs. 38.9%). CYRAMZA was well-tolerated in Chinese patients and the overall patient population. The safety and efficacy profile of CYRAMZA in the Chinese population was consistent with that observed in previously reported global studies[2].

Professor Shukui Qin, the principal investigator of REACH-2 in China and the Director of the Cancer Center of Nanjing Jinling Hospital stated, "Primary Liver Cancer (PLC) is the fourth most common cancer in terms of prevalence and the second leading cause of cancer-related mortality in China with only a 12.1% five-year survival rate. HCC is the main type of PLC and most HCC patients with AFP ≥ 400ng/ml experience greater disease progression on or after first-line treatment[3]. New treatment options are urgently needed to improve outcomes in these patients[4]. Globally, CYRAMZA is the first approved novel medicine specifically evaluated in the biomarker-enriched population of HCC patients with AFP ≥ 400ng/ml; the study results in Chinese patients demonstrated a consistent efficacy and safety profile with the global population. I believe the approval will ignite a positive impact on the clinical practice of liver cancer in China, bringing a new and efficacious treatment option for Chinese patients with advanced HCC."

Dr. Yongjun Liu, President of Innovent, stated, "Hepatocellular carcinoma ranks fifth among the number of new cases in China, with approximately 410,000 new cases yearly and the number of deaths each year are nearly the same[3]. Most patients will experience disease progression after current first-line therapy and are left with limited treatment options. We are excited about the approval of CYRAMZA, the first innovative drug proven to have clinical benefits for a biomarker-enriched population of patients with HCC. This differentiated product will potentially be an exciting treatment option and bring new hope to patients in China with advanced HCC. The successive approvals of CYRAMZA in second-line GC/GEJ and HCC this year enable us to provide integrated patient solutions with strong portfolio synergies while enhancing our leading franchise in these two large cancer indications. Innovent is fully committed to making these new treatment options available to benefit more cancer patients in China as soon as possible."

About Hepatocellular Carcinoma

Primary liver cancer(PLC)is a common malignancy of the digestive system worldwide, among which about half of all new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), which accounts for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma(ICC)and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.[5]

About CYRAMZA (ramucirumab)

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds specifically to VEGFR-2, thereby blocking the binding of the receptor ligands (VEGF-A, VEGF-C, and VEGF-D) – which may slow tumor growth.[6] In recent years, studies have shown that the VEGF pathway is an important signaling pathway involved in tumor angiogenesis, and it is also the main target pathway in targeted therapy of liver cancer[7]. From the existing research results, the single drug use of compounds targeting the VEGF pathway can bring survival benefits to patients and is a very promising treatment method in the treatment of liver cancer.[7]

In March 2022, CYRAMZA (ramucirumab) in combination with paclitaxel was approved by the National Medical Products Administration (NMPA) for second-line treatment in patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma.

In October 2022, CYRAMZA (ramucirumab) was approved by the NMPA for patients with Hepatocellular Carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

About Innovent’s Strategic Cooperation with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly will co-develop and commercialize oncology medicines, including TYVYT (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered into a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. This collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China’s innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization. In August 2020,Lilly and Innovent announced a global expansion of their strategic alliance for sintilimab, whereby Lilly obtained an exclusive license for sintilimab for geographies outside of China and plans to pursue registration of sintilimab in the U.S. and other geographies outside of China. In March 2022, Lilly and Innovent entered into a fifth agreement to expand their strategic partnership in oncology, in which Innovent obtained the sole commercialization rights to import, market, promote, distribute and detail CYRAMZA (ramucirumab) and selpercatinib once approved in Mainland China, and a right of first negotiation for potential future commercialization of pirtobrutinib in Mainland China.

The China NMPA Approves Selpercatinib for the Treatment of Patients with RET-driven Lung and Thyroid Cancers

On October 9, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, reported that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for selpercatinib (40mg & 80mg capsules) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer (TC) with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) (Press release, Innovent Biologics, OCT 9, 2022, View Source [SID1234621842]).

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Selpercatinib is a selective and potent RET kinase inhibitor that was discovered and developed by Eli Lilly and Company. In March 2022, Innovent and Lilly expanded their strategic partnership in oncology, which includes an agreement for Innovent to obtain the sole commercialization rights of selpercatinib once approved in China, positioning Innovent to be fully responsible for the pricing, importation, marketing, distribution and detailing of this product. With this further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers and to provide integrated patient solutions with strong synergies to cancer patients in China.

Selpercatinib was globally the first RET inhibitor granted accelerated approval by the FDA in May 2020,[1] under the brand name Retevmo. In November 2021, the NDA for selpercatinib was accepted by the Center for Drug Evaluation (CDE) of NMPA in China and was granted priority review to expedite the review process. The NDA approval was based on data from the global LIBRETTO-001 study and data from the Chinese patient population in the LIBRETTO-321 study.

Selpercatinib was evaluated in the Phase I/II LIBRETTO-001 study, the largest clinical trial ever reported in patients with RET-driven cancers. The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DoR). The updated results of patients with NSCLC and medullary thyroid cancer were presented at the European Lung Cancer Congress (ELCC) 2022[2] and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022,[3] respectively.

Selpercatinib demonstrated potent and durable antitumor activity with a favorable safety profile in patients with locally advanced or metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC and advanced RET fusion-positive TC.

Ÿ In patients with NSCLC, the IRC-assessed ORR was 84.1% (95% CI:73, 92), median DoR was 20.2 months (95% CI:13, NE), median PFS was 22 months(95% CI:14, NE). Pre-treated patients (N=247) achieved an ORR of 61.1% (95% CI:55, 67), with a median DoR of 28.6 months (95% CI:20, NE) and a median PFS of 24.9 months (95% CI:19, NE).[2]

Ÿ In cabozantinib/vandetanib (cab/van) naïve patients (N=142) and cab and/or van pre-treated patients with MTC (N=151), IRC-assessed ORRs were 81.0% and 73.5%, respectively. Despite a median follow-up of ∼2 yrs, DoR and PFS data are still immature, with response ongoing in most naïve patients. Pre-treated patients achieved a median PFS of 34 months (95% CI:26, NE) and DoR has not been reached yet.[3]

Ÿ In naïve patients with TC (N=12), the IRC-assessed ORR was 92% (95% CI:62, 100), median DoR was NE (95% CI:15, NE), PFS in 1 year was 100% (95% CI:100, 100).[3],[4] In pre-treated patients with TC (N=22), the IRC-assessed ORR was 77% (95% CI:55,92), median DoR was 18 months (95% CI:10, NE), PFS in one year was 69% (95% CI:43, 85).[4]

Ÿ Selpercatinib was well-tolerated with most adverse events (AE) being low grade which are manageable and reversible. Three to four percent of patients discontinued treatment due to treatment-related AEs.[2]-[4]

LIBRETTO-321 study[5],[6] is an open-label, multicenter, Phase II study to assess the safety and efficacy of selpercatinib in participants in China with RET fusion-positive solid tumors. Of the 77 enrolled patients, 47 had RET fusion-positive NSCLC, 29 had RET-mutant MTC and one had RET fusion-positive TC. The results have been published in Therapeutic Advances in Medical Oncology in July[5] (NSCLC part) and in August[6] (MTC/TC part) in 2022.

The safety and efficacy profile of selpercatinib in the Chinese population was consistent with that observed in previously reported global studies.

Ÿ After 9.7 months of median follow-up, IRC-assessed ORR in the primary analysis set (PAS) of patients with NSCLC (N = 26) was 69.2% (95% CI:48.2, 85.7) and 94.4% of responses were ongoing; the ORR was 87.5% and 61.1% in treatment-naïve and pre-treated patients, respectively.[5]

Ÿ After 8.7 months of median follow-up, IRC-assessed ORR in the PAS of patients with MTC (N = 26) was 57.7% (95% CI:36.9, 76.6) and 93.3% of responses were ongoing; the ORR was 58.8% (95% CI:32.9, 81.6) and 55.6% (95% CI:21.2, 86.3) in treatment-naïve and pre-treated patients, respectively.[6]

Ÿ One treatment-naïve patient with TC was treated for 23.4 weeks and achieved a confirmed partial response (PR) at week eight. A maximum tumor burden shrinkage of 43% was determined by the IRC and the response was ongoing at cutoff.[6]

Ÿ Selpercatinib was well-tolerated with most adverse events (AE) being low grades which are manageable and reversible. Three (3.9%) patients discontinued therapy due to treatment-related AEs.[5],[6]

Professor Shun Lu from Shanghai Chest Hospital of Shanghai Jiao Tong University stated, "RET is a relatively rare target for NSCLC in the context of the high prevalence of NSCLC in China’s patient population, but there exists a certain absolute base of patients whose survival status is equally noteworthy. Selpercatinib demonstrated efficacy in treating patients with RET fusion-positive NSCLC in the global LIBRETTO-001 Phase I/II clinical study, with a median PFS of about two years.[2] The LIBRETTO-321 study further showed that selpercatinib significantly improved the efficacy of Chinese patients with advanced RET fusion-positive NSCLC, including patients with brain metastases, and the response was clinically meaningful and durable.[5] We are thrilled that the approval will bring new treatment options to Chinese patients with RET fusion-positive NSCLC."

Professor Cheng Ying from Jilin Cancer Hospital stated, "The current global incidence of RET fusions in NSCLC patients is 1% to 2%, and the incidence of RET fusion NSCLC in China is 1.4%.[7],[8] In the past, there have been limited therapies available for RET fusion-positive NSCLC to achieve satisfactory efficacy. In recent years, the introduction of RET inhibitors has opened a new era of therapy for such patients. As observed in the LIBRETTO-321 study, the ORR of selpercatinib in naïve and pre-treated patients in the Chinese population is very exciting. In addition, selpercatinib has also shown antitumor activity against brain lesions in preclinical models.[5] We believe that the approval of selpercatinib in China will bring more survival benefits to Chinese patients with RET fusion-positive NSCLC."

Professor Ming Gao from Tianjin People Hospital stated, "RET alterations are oncogenic drivers in thyroid cancer, mostly seen in MTC. Selpercatinib is a highly selective and potent RET kinase inhibitor. In the LIBRETTO-001 study, the largest clinical trial ever reported in patients with RET-driven cancers, selpercatinib demonstrated clinically meaningful and durable responses in RET-altered thyroid cancer.[6] The LIBRETTO-321 study has further demonstrated that the safety and efficacy profile of selpercatinib in the Chinese population was consistent with that observed in a previously reported global study. Its approval is undoubtedly a breakthrough milestone, and we hope more TC patients in China will benefit from it in the future."

Dr. Yongjun Liu, President of Innovent, stated, "Globally, selpercatinib is the first RET inhibitor approved and we are pleased to see its strong and durable response in line with good tolerability in clinical studies. This approval marks another milestone in mainland China for targeted therapies and will bring a new treatment option with high quality to RET fusion-positive cancer patients in China. For Innovent, the addition of a high-value commercialized product in our TKI BU will further enhance the synergistic value in the pipeline portfolio as well as our franchise in certain cancer types. We are committed to the partnership with Lilly to accelerate the launch of innovative medicines to benefit more cancer patients in China as soon as possible."

About RET-driven Cancers

Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 1-2% of NSCLC;[9] and 10-20% of papillary thyroid cancers.[10] Activating RET point mutations account for approximately 60% of sporadic MTC and approximately 90% of familial MTC.[11] RET fusion-positive cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. Activating RET alterations are predominantly mutually exclusive from other oncogenic drivers.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death and the most commonly diagnosed tumor type in China with an overall five year survival rate of less than 15%.[12] Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer. RET fusions have been identified in about 1.4% of Chinese patients with NSCLC and the incident cases are above 10,000 every year.8 Up to 50% of patients with RET fusion-positive NSCLC can have tumors that metastasize to the brain.[13]

About Thyroid Cancer (TC)

Thyroid cancer is a cancer that starts in a person’s thyroid gland. The most common types of thyroid cancer are papillary and follicular. Other types include Hurthle cell, medullary and anaplastic. Studies show that the positive rate of RET fusion in the Chinese TC patient population is about 6.03% with about 3,484 new cases each year in China;[14] the positive rate of RET mutations in the Chinese sporadic MTC and familial MTC are approximately 42% and 88.8%, respectively, with about 1,795 new cases each year in China.[15]

About Selpercatinib

Selpercatinib is a selective and potent RET kinase inhibitor with CNS activity. In the U.S., selpercatinib was approved by the FDA in May 2020, under the brand name Retevmo, as the first therapy specifically indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In Sep 2022, the FDA granted an accelerated approval for a tumor-agnostic indication for selpercatinib in adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib, is the first and only RET inhibitor to get this indication. In addition to the tumor-agnostic approval, the FDA has granted traditional approval for Retevmo in adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

About Innovent’s strategic cooperation with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focusing on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Lilly and Innovent will co-develop and commercialize oncology medicines, including TYVYT (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered into a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. This collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China’s innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization. In August 2020,Lilly and Innovent announced a global expansion of their strategic alliance for sintilimab, whereby Lilly obtained an exclusive license for sintilimab for geographies outside of China and plans to pursue registration of sintilimab in the U.S. and other geographies outside of China. In March 2022, Lilly and Innovent entered into a fifth agreement to expand its strategic partnership in oncology, in which Innovent obtained the sole commercialization rights to import, market, promote, distribute and detail CYRAMZA (ramucirumab) and selpercatinib once approved in Mainland China, and a right of first negotiation for potential future commercialization of pirtobrutinib in Mainland China.