On September 15, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Takeda, SEP 15, 2021, View Source [SID1234587769]). EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The approval of EXKIVITY introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer," said Teresa Bitetti, president, Global Oncology Business Unit, Takeda. "EXKIVITY is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community."

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients, as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions.

"EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs," said Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute. "The approval of EXKIVITY (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses."

"Patients with EGFR Exon20 insertion+ NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed, but also lacking targeted treatment options that can improve response rates," said Marcia Horn, executive director, Exon 20 Group at ICAN, International Cancer Advocacy Network. "As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy."

The FDA approval is based on results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the Phase 1/2 trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The EXKIVITY Prescribing Information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

The FDA review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners. We look forward to continuing our work with regulatory agencies across the globe to bring mobocertinib to patients.

Delivering Takeda’s Wave 1 Pipeline
Takeda is positioned to deliver near-term growth through global brand expansions and its Wave 1 pipeline, which includes multiple best-in-class/first-in-class new molecular entities (NMEs) with potential for approvals through FY2024. Our Wave 2 pipeline contains approximately 30 NMEs and next-generation platforms that will support Takeda’s sustainable growth through FY25 and beyond.

About EXKIVITY (mobocertinib)
EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is approved in the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Results from the Phase 1/2 trial of mobocertinib have also been accepted for review by the Center for Drug Evaluation (CDE) in China for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who have been previously treated with at least one prior systemic chemotherapy.

For more information about EXKIVITY, visit www.EXKIVITY.com. For the Prescribing Information, including the Boxed Warning, please visit View Source

About EGFR Exon20 Insertion+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

EXKIVITY IMPORTANT SAFETY INFORMATION
QTc Interval Prolongation and Torsades de Pointes: EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation. Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed.
Cardiac Toxicity: Monitor cardiac function, including left ventricular ejection fraction, at baseline and during treatment. Withhold, resume at reduced dose or permanently discontinue based on severity.
Diarrhea: Diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Monitor electrolytes and advise patients to start an antidiarrheal agent at first episode of diarrhea and to increase fluid and electrolyte intake. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective non-hormonal contraception.

Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

On September 15, 2021 Herantis Pharma Plc ("Herantis" or the "Company") reported the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing") (Press release, Herantis Pharma, SEP 15, 2021, View Source,c3416074 [SID1234587799]). The Company announced the launch of the Placing by way of a company release published on 15 September 2021. Herantis raises gross proceeds of EUR 4.04 million in the Placing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the Placing, the Company expects to issue a total of 1,346,500 Placing Shares in a directed share issue. The Placing Shares represent approximately 13.8 per cent. of the issued shares in Herantis prior to the Placing and approximately 12.1 per cent. of the issued shares in Herantis following the Placing. The total number of issued shares in the Company after the Placing will be 11,103,568.

The subscription price of the Placing Shares is EUR 3.00 per Placing Share, corresponding to a discount of 6.5 per cent to the closing price on First North Growth Market Finland immediately before the commencement of the Placing on 15 September 2021. The subscription price shall be recorded in the invested unrestricted equity reserve.

The Placing was carried out based on offers received in an accelerated book building and based on the authorisation given to the board of directors by the Company’s extraordinary general meeting of 2 December 2020.

As previously announced, Acme Investments SPF Sarl, a company controlled by Timo Syrjälä, and Nanoform Finland Plc participated in the Placing among several other investors.

The Placing Shares (ISIN code FI4000087861) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 16 September 2021. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 20 September 2021.

Herantis intends to make applications for the admission into trading of the Placing Shares on Nasdaq First North Growth Market Finland and on Nasdaq First North Growth Market Sweden. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 20 September 2021, subject to the respective listing applications being approved.

The CEO of Herantis, Craig Cook comments: "We are pleased with the support amongst existing as well as respected new shareholders in Herantis. The funds will clearly enable us to continue the important development activities of our novel disease-modifying CNS drugs rhCDNF and xCDNF (HER-096). These assets are the epitome of our ground-breaking science and have the potential to slow, stop or even reverse the progression of neurodegenerative diseases with high impact for patients and society. Herantis is well positioned to capitalize on this momentum and create value for our growing list of world class shareholders."

Swedbank AB (publ) is acting as the global coordinator and bookrunner of the Placing in association with Kepler Cheuvreux. Krogerus Attorneys Ltd is acting as the legal counsel to the Company as to Finnish law and Borenius Attorneys Ltd is acting as the legal counsel to the global coordinator and bookrunner of the Placing as to Finnish law.

On September 15, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the investigational new drug (IND) application of multi-specific antibody CS2006/NM21-1480 has been approved by the National Medical Products Administration (NMPA) of China (Press release, CStone Pharmaceauticals, SEP 15, 2021, View Source [SID1234587864]). CS2006/NM21-1480 represents a leading class of next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for combinations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA).CS2006/NM21-1480 is designed to bind to the immune co-stimulation receptor 4-1BB and conditionally activate T cells only when engaging the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies. As a potential best-in-class drug, CS2006/NM21-1480 could be used as monotherapy or in combination with multiple treatments. The upcoming clinical study is designed to evaluate the safety, pharmacokinetics, and anti-tumor efficacy of CS2006/NM21-1480 in Chinese patients with various advanced solid tumors.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding is designed to fully exploit the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB, to provide broader and more sustained treatment response and at the meantime, to avoid systemic toxicities. Furthermore, half-life extension via the HSA-binding motif enables convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

Dr. Archie Tse, Chief Scientific Officer of CStone, said, "We are very glad that the IND application of CS2006/NM21-1480 in China has been approved by the NMPA, with the clinical trial starting soon, it marks a significant milestone in CStone’s Pipeline 2.0 strategy which focused on assets with first-in-class or best-in-class potential. Since April 2020, the first-in-human study of CS2006/NM21-1480 has been well underway in the US. Moving forward, we will step up our efforts to drive the research and development of CS2006/NM21-1480, and other pipeline assets to provide potentially more effective treatments for Chinese and global patients."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase Ib clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan), South Korea and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.

On September 15, 2021 Celularity Inc. (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported the appointment of Andrew L. Pecora, M.D., F.A.C.P., C.P.E., as President effective today (Press release, Celularity, SEP 15, 2021, View Source [SID1234591817]). Reporting to Robert J. Hariri, M.D., Ph.D., Chairperson and Chief Executive Officer, Dr. Pecora will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval, including responsibility for preclinical and clinical development and regulatory affairs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It is with great pleasure that we announce Andrew’s appointment as Celularity’s President," said Dr. Hariri. "Building on our recent Nasdaq listing, Andrew’s proven track record as an executive leader in biotechnology and healthcare innovation, delivery and reimbursement will help take Celularity to the next level as we advance our clinical pipeline of next-generation placental-derived cellular therapeutic candidates. Andrew and I trained together at the Weill Cornell Medical Center and have worked in cellular medicines on parallel paths for over 30 years," Dr. Hariri continued.

Dr. Pecora commented, "I am excited to take on this new role at Celularity. I have been very impressed by the early clinical insights and underlying translational science of these novel, placental-derived, off-the-shelf cellular medicines. The potential of Celularity’s clinical pipeline, including its CYNK-101, CyCART-19 and APPL-001 programs, is tremendous. I look forward to providing leadership and strategic vision, working with Bob and his team to realize the potential of these novel allogeneic cell therapies for patients with cancer, infectious disease and degenerative disease."

Dr. Pecora is an award-winning clinician, scientist, and healthcare executive and innovator, with a track record of success leading biotechnology companies to pioneer novel cellular medicines. He is among the world’s foremost experts in blood and bone marrow stem cell transplantation, drug development, and the advancement of novel cell therapies. Dr. Pecora previously served as President of the Physician Enterprise, Chief Innovations Officer, and the Institutional Research Official of Hackensack Meridian Health. There, he oversaw more than 7,500 physicians as well as the business and clinical operations of the John Theurer Cancer Center and clinical and basic research of the Center for Discovery and Innovation. Dr. Pecora also is a Professor of Medicine and Oncology at Georgetown University.

Dr. Pecora is Founder and serves as Chairman of Cota, Inc., a real-world evidence-based data and analytics company focused on leveraging information technology and big data analytics to bridge the gap between precision medicine and population-based health outcomes and to accelerate the development of innovative medicines for patients with difficult to treat diseases.

Prior to Cota, Dr. Pecora served as Co-Founder, Chair and CEO of Progenitor Cell Therapy (PCT), an internationally recognized cellular medicine cGMP manufacturing company. He facilitated the purchase of the Dendreon, Inc., which ultimately led to the FDA approval of PROVENGE (sipuleucel-T), the first FDA approved cell therapy used to treat certain men with advanced prostate cancer. Dr. Pecora eventually led the sale of PCT to Caladrius Biosciences, and co-led multiple public and private capital raises that exceeded USD 500 million.

Earlier in his career, Dr. Pecora was Founder and Chairman of Amorcyte, Inc., a clinical-stage cell therapy company focused on developing novel treatments for cardiovascular disease. At Amorcyte, Dr. Pecora led the capital raise, preclinical and clinical development efforts for AMR-001, a cellular therapy product candidate for vascular injury, through Phase 1 development. This work led to Amorcyte’s sale to Caladrius Biosciences, where Dr. Pecora led the regulatory and clinical development efforts for Amorcyte through Phase 2 development and facilitated a Phase 3 registration trial in Japan.

Dr. Pecora has authored more than 200 peer-reviewed publications and holds over 50 patents, many involving cellular medicines. He has led numerous clinical trials in cancer and other diseases serving as principal investigator. He also has served on national and international steering committees, and contributed to international guidelines for development of cellular medicines, FDA regulatory approval and commercialization standards, including FACT-ISCT International Standards for Hematopoietic Cellular Therapy Production, Processing and Administration. An award-winning healthcare executive, he was recognized in 2019 by Modern Healthcare as one of the top 50 influential clinical healthcare executives.

On September 15, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) (Press release, Coherus Biosciences, SEP 15, 2021, View Source [SID1234587736]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the addition of toripalimab to standard of care gemcitabine-cisplatin (GP) chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC provided superior progression free survival (PFS) compared to GP alone [median PFS of 11.7 vs 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003], and with a manageable safety profile. The impact of the addition of toripalimab on PFS was demonstrated in patients regardless of PD-L1 expression status. Although overall survival data were not yet mature, as of February 18, 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364–0.997)). The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), TEAEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal TEAEs (2.7% vs 2.8%) was similar between both arms. Immune-related adverse events (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab arm. The full results can be found in the on-line edition of Nature Medicine.

"There are currently no PD-1 blocking antibodies approved for NPC in the United States. We are pleased that this study has been selected for cover article publication in this highly-respected journal," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "This is a strong signal that further validates the potential advance that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC, an aggressive and difficult-to-treat cancer."

A biologics license application has been submitted to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

About JUPITER-02
The JUPITER-02 Study (ClinicalTrials.gov identifier: NCT03581786) is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical trial comparing the efficacy and safety of toripalimab versus placebo in combination with Gemcitabine/Cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Professor Ruihua Xu from Sun Yat-sen University Cancer Centre is the lead principal investigator of the study. The largest Phase 3 clinical trial to date evaluating a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, JUPITER-02 was conducted in mainland China, Taiwan and Singapore and enrolled a total of 289 patients.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.