On June 27, 2019 ArQule, Inc. (Nasdaq: ARQL) reported the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,387,500 shares at the public offering price of $9.75 per share (Press release, ArQule, JUN 27, 2019, View Source [SID1234537297]). The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by ArQule to 10,637,500 shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses of the offering payable by ArQule, to approximately $103.7 million.

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The Company intends to use the net proceeds of the offering to fund its clinical programs and for general corporate purposes.

SVB Leerink and RBC Capital Markets acted as joint bookrunning managers for the offering. Oppenheimer & Co. Inc. and Needham & Company acted as co-lead managers, and Roth Capital Partners, B. Riley FBR and JonesTrading Institutional Services LLC acted as co-managers for the offering.

The securities described above were offered by ArQule pursuant to an effective shelf registration statement on Form S-3 (File. No. 333-232306), including a base prospectus, that was filed by ArQule with the Securities and Exchange Commission ("SEC") and automatically became effective on June 24, 2019. A final prospectus supplement and accompanying prospectus relating to the offering filed with the SEC is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On June 27, 2019 AstraZeneca reported positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients (Press release, AstraZeneca, JUN 27, 2019, View Source [SID1234537295]).

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A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy options vs. chemotherapy alone. The safety and tolerability for this Imfinzi combination was consistent with the known safety profiles of these medicines.

AstraZeneca will submit these results for presentation at a forthcoming medical meeting.

José Baselga, Executive Vice President, Oncology R&D said: "The Phase III CASPIAN results offer new hope for patients who are facing the devastating diagnosis of small cell lung cancer, and for whom new medicines are urgently needed. This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options."

CASPIAN is a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy options or the combination of Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone as a 1st-line treatment for patients with extensive-stage SCLC. The trial will continue to the final analysis of OS for the combination of dual immune checkpoint blockade with chemotherapy. This combination includes tremelimumab, an anti-CTLA4 antibody and potential new medicine, with Imfinzi, an anti-PDL1 antibody, and chemotherapy.

Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.

Imfinzi is approved for unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial.

About CASPIAN

The CASPIAN trial is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of patients with extensive-stage SCLC. The trial compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and prophylactic cranial irradiation.

The trial is being conducted in more than 200 centres across 22 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint is OS.

About small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.2 About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.3 SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.4 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.3

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau and Hong Kong.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumours.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso (osimertinib) and ongoing Phase III trials FLAURA, ADAURA and LAURA as well as the Phase II exploratory combination trials SAVANNAH and ORCHARD.5-7

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Imfinzi (durvalumab), an anti-PDL1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III trials).

About AstraZeneca’s approach to Immuno-Oncology (IO)

IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On June 27, 2019 LSK BioPharma (LSKB) reported that it has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460 advanced or metastatic gastric cancer patients (Press release, LSK BioPharma, JUN 27, 2019, View Source [SID1234537293]). While the rivoceranib arm did achieve better median overall survival (OS) compared with placebo, and a result comparable to other approved drugs in gastric cancer, the result was not statistically significant. Overall survival was the primary endpoint in the ANGEL study. Rivoceranib demonstrated a highly significant improvement in median progression-free survival (PFS), which was a secondary endpoint. Rivoceranib was also generally well tolerated and safety results were consistent with prior studies. LSKB will conduct analyses as additional data become available such as overall response rate (ORR) and time-to-progression, follow surviving patients, and keep an open dialogue with regulatory agencies to determine the appropriate path to approval for rivoceranib in this gastric cancer monotherapy indication. The Company plans to continue ongoing clinical development programs in other indications including, earlier lines of therapy for gastric cancer with combination therapy, colorectal cancer, and hepatocellular carcinoma.

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About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 260 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.

On June 27, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Ministry of Health Labour and Welfare (MHLW) granted an additional approval for FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek (entrectinib) for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion positive solid tumors on June 26, 2019 (Press release, Chugai, JUN 27, 2019, View Source [SID1234537292]). The approval enables FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for Rozlytrek by detecting NTRK fusion genes (fusion genes between NTRK1, NTRK2, NTRK3 and other genes). Rozlytrek is a ROS1/TRK inhibitor and was approved for the treatment of adult and pediatric patients with NTRK fusion positive advanced and recurrent solid tumors on June 18, 2019.

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"The conventional concept of cancer treatment focuses on the site where the cancer started. However, it is drastically changing with the emergence of a completely new approach called tumor agnostic treatment; an approach which targets genomic mutations that drive cancers instead of the tumor location in the body. We are proud of the MHLW approval of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for Rozlytrek which represents this new tumor agnostic treatment approach," said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. "A comprehensive genomic profiling test is especially beneficial in identifying rare gene mutations expressed in multiple cancer types, including NTRK gene fusions. Chugai will further strive to provide services to help physicians’ swift and appropriate decision making in order to realize patient-centric healthcare."

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection and analysis of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from patient’s tumor tissues. As a comprehensive companion diagnostic function, it can be also used as a companion diagnostic for certain molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare providers through comprehensive genomic profiling.

[Note]
A press release issued on June 18, 2019: Anti-Cancer Agent Rozlytrek, Approved for the Treatment of NTRK Fusion Gene Positive Advanced/Recurrent Solid Tumors
View Source

Approval information The underlined part has been newly added.

Brand name FoundationOne CDx Cancer Genomic Profile
Nonproprietary name
Gene mutation analysis program (for use in cancer genome profiling)
Somatic gene mutation analysis program (for use in assessing anticancer drug indications)
Intended uses or indications
The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
EGFR exon 19 deletions and EGFR exon 21 L858R alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib
Conditions for approval
The necessary measures must be taken to ensure that the product is used by a physician with adequate knowledge and experience of cancer genomic medicine at a medical institution with a cancer genome profiling-based medical system pursuant to the "Guidelines for the Development of Core Hospitals and Other Facilities for Cancer Genomic Medicine," and in compliance with the scope and timing of testing stipulated in the most recent guidelines, etc., of relevant academic societies.
Appropriate procedures and controls to protect personal information and up-to-date security and privacy protection measures to prevent unauthorized access must be implemented for tumor tissue specimens sent to the laboratory and for information obtained from these specimens.
Quality control of input data must be performed as described in the Remarks column of the attached Application Form. Any changes to the quality control of input data as described in the Remarks column of the Application Form (excluding minor changes specified by Order of the MHLW in Article 23-2-5, paragraph (11) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices ["the Act"]) must be approved by the MHLW Minister pursuant to Article 23-2-5, paragraph (11) of the Act. Note that this approval applies mutatis mutandis to the provisions of Article 23-2-5 paragraph (13), Article 23-2-6, and Article 23-2-7 of the Act.
About Rozlytrek
Rozlytrek is an oral tyrosine kinase inhibitor that blocks ROS1 (c-ros oncogene 1) and TRK (neurotrophin receptors) family strongly and selectively. It blocks ROS1 and TRK kinase activity, and inhibits proliferation of cancer cells with ROS1 or NTRK gene fusions. Rozlytrek has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration and Priority Medicines designation by the European Medicines Agency for the treatment of NTRK fusion gene positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies. FDA has granted priority review for Rozlytrek for the treatment of NTRK fusion-positive solid tumors and ROS1 fusion-positive non-small cell lung cancer (NSCLC). In Japan, Chugai filed an application for approval of ROS1 fusion gene positive NSCLC in March 2019.

About NTRK fusion gene positive cancer
NTRK fusion gene is an abnormal gene that can be formed by fusing the NTRK genes (NTRK1, NTRK2, NTRK3 encode TRKA, TRKB, TRKC protein, respectively) and other genes (ETV6, LMNA, TPM3, etc.) as a result of chromosomal translocation1-3). The TRK fusion kinase made from NTRK fusion gene is thought to promote cancer cell proliferation. There is very rare expression of NTRK fusion but in various adult and pediatric solid tumors, including infantile fibrosarcoma, glioma, glioblastoma, diffuse intrinsic pontine glioma (DIPG), congenital mesoblastic nephroma, melanoma, inflammatory myofibroblastic tumor (IMT), uterus sarcoma, soft tissue tumor, gastrointestinal stromal tumor (GIST), secretory carcinoma of breast, secretory carcinoma of salivary gland, cancer of unknown primary, lung cancer, colorectal cancer, appendiceal cancer, breast cancer, gastric cancer, ovarian cancer, thyroid cancer, cholangiocarcinoma, pancreatic cancer, head and neck cancer, and various sarcomas.

Trademarks used or mentioned in this release are protected by laws.

[References]

Martin-Zanca D, Hughes SH, Barbacid M. A human oncogene formed by the fusion of truncated tropomyosin and protein tyrosine kinase sequences. Nature 1986; 319(6056): 743-8.
Martin-Zanca D, Oskam R, Mitra G, Copeland T, Barbacid M. Molecular and iochemical Characterization of the Human trk Proto-Oncogene. Molecular and Cellular Biology 1989; 9(1): 24-33.
Lange AM, Lo HW. Inhibiting TRK Proteins in Clinical Cancer Therapy. Cancers 2018; 10: 105.

On June 27, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly reported that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301, a co-developed biosimilar product candidate of rituximab (MabThera/Rituxan) (Press release, Innovent Biologics, JUN 27, 2019, View Source [SID1234537283]). This NDA by Innovent is the fourth that has been accepted by the NMPA following Tyvyt (sintilimab injection), IBI303 (a biosimilar product candidate of adalimumab injection, granted priority review status) and IBI305 (a biosimilar product candidate of bevacizumab injection, granted priority review status).

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IBI301 is a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody for injection co-developed by Lilly and Innovent for the treatment of non-Hodgkin’s lymphoma (NHL) and other diseases. Rituximab was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of NHL in November 1997, followed by approvals in chronic lymphocytic leukemia (CCL), rheumatoid arthritis (RA), and other disease indications. Branded rituximab has been well-recognized for its proven efficacy and safety profile. Despite the high unmet demand for effective cancer therapies in China, the adoption rate of rituximab is relatively low due to low affordability. The biosimilar product candidate of rituximab, IBI301, is expected to offer a high-quality and affordable alternative to patients in China.

The NDA is based on clinical data generated from two clinical studies, namely: a Phase 3 comparative study of efficacy and safety in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study in patients with CD20-positive B-cell lymphoma. Both studies directly compare IBI301 to rituximab and have met their pre-defined primary endpoints.

"Two clinical studies have been conducted with rituximab injection as the control arm. Based on the high-quality clinical data, the NDA of IBI301 has been accepted by NMPA. We believe that the high-quality rituximab biosimilar will improve drug availability and benefit more patients and their families," said Professor Lugui Qiu from Blood Diseases Hospital, Chinese Academy of Medical Sciences.

"The Phase 3 study comparing IBI301 with rituximab when each is used in combination with standard chemotherapy (CHOP) in patients with DLBCL shows an objective response rate (ORR) and safety profile consistent with that of branded rituximab, which suggests biosimilarity between IBI301 and rituximab injection. We hope that the drug can be launched soon to benefit more lymphoma patients," said Professor Jun Zhu, Beijing Cancer Hospital.

Dr. Li Wang, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, commented, "The NDA of IBI301 represents another millstone of strategic cooperation between Lilly and Innovent. We hope that IBI301 can be approved soon in order to offer an affordable treatment option for lymphoma patients in China."

"At present, we have fourteen assets in clinical research stage, four products in phase 3 clinical trials, and one, Tyvyt (sintilimab injection), is now successful approved and launched on the market. IBI301 is the fourth NDA filing Innovent has submitted to NMPA. We are excited about reaching this important milestone and hope to bring the high-quality drug to more patients. We’ll strive to deliver high-quality biopharmaceutical drugs from our rich pipeline to benefit more and more ordinary people," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About non-Hodgkin’s lymphoma

Malignant lymphoma is one of the most common hematological malignancies in China. It is one of the top ten malignant tumors with high morbidity and mortality. In recent years, the incidence of malignant lymphoma has been rising. According to histopathology, lymphoma can be divided into Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), of which NHL accounts for the majority. NHL is a general term for a series of related but different lymphoid malignant tumors. Most (80-85%) originates from B cells. The rest originates from T cells or an undetermined cell type. More than 95% of B-cell non-Hodgkin’s lymphoma cells express CD20. The incidence of NHL increases with age. The most common type of NHL in China is diffuse large B-cell lymphoma (DLBCL), accounting for 40-50% (about 30-40% in Western countries). DLBCL is a moderately malignant to highly malignant invasive lymphoma that progresses rapidly and leads to the death of patients within a few months without treatment. The clinical efficacy and safety of rituximab in CD20-positive non-Hodgkin’s lymphoma have been confirmed in several large-scale clinical trials.

About IBI301

IBI301 is a biosimilar of rituximab, a recombinant human-mouse chimeric anti-CD20 monoclonal antibody for injection co-developed by the Group and Eli Lilly and Company. Rituximab is a monoclonal antibody which binds to CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity ("CDC") and antibody-dependent cellular cytotoxicity ("ADCC"). The normal and malignant B cells in the mediator dissolve, thereby achieving an anti-tumor therapeutic effect.