Marketing Application for Enlonstobart Has Been Accepted by the National Medical Products Administration

On March 12, 2023 CSPC (1093.HK) reported that the application for marketing of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary company of CSPC, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China, with eligibility for the conditional approval pathway (Press release, Sumgen Biotech, MAR 12, 2023, View Source;a=nav&id=346 [SID1234656267]). Enlonstobart for injection was originally developed by Hangzhou Sumgen Biotech Co., Ltd. (referred to as "Sumgen Biotech"). Itsfirst clinical trial was approval on September 29, 2018, soon afterwards Sumgen Biotech entered into a strategic partnership with CSPC in November 2018.

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!

Enlonstobart for injection is a recombinant fully human anti-PD-1 monoclonal antibody, belonging to the IgG4 monoclonal antibody drug. It is applied as a Class 1 therapeutic biological product for the treatment of relapsed or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. A phase III confirmatory clinical trial of the product for the first-line treatment of cervical cancer has also been initiated with approval granted by the NMPA. Multiple clinical trials for other indications are also progressing steadily.

Enlonstobart is the first innovative drug independently developed by Sumgen Biotech, and the company has achieved strategic cooperation with CSPC. The acceptance and conditional approval for the application of marketing is a significant milestone for this project, as well as a major achievement in Sumgen Biotech’s development journey. It marks a new phase in Sumgen Biotech’s innovative antibody research and development.

GenScript Biotech Announces 2023 Annual Results with a Five-Year CAGR stands at 30%

On March 11, 2024, GenScript Biotech Corporation (HK.1548), a world’s leading technology and service provider of life science R&D and manufacturing, reported its annual results for the year ended December 31, 2023 (Press release, GenScript, MAR 12, 2023, View Source [SID1234644730]). During the reporting period, GenScript Group’s revenue continued to grow at a fast pace, with a year-on-year increase of 34.2%, reaching approximately $840 million, and the five-year CAGR stands at 30%. The group’s global operations are robust, with stable cash flow, laying a solid foundation for long-term development. In particular, the group’s cell therapy segment saw significant revenue growth, and the life science, industrial synthetic biology, and other businesses also achieved varying levels of growth. As the core competitiveness and key to GenScript’s continuous development, the group will continue to strengthen its innovation capabilities and remain committed to creating more value for customers.

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!

Continued High Growth, Empowering Customers

From the performance during the 2023 reporting period, GenScript Group’s overall development is optimistic, with each business segment having its own highlights.

Legend Biotech, a subsidiary of GenScript in the cell therapy segment, achieved external revenue of $285 million in 2023, representing an increase of 144.2%. Currently, Legend Biotech has cash reserves of about $1.3 billion, which is expected to fund operating activities and capital expenditure plans till the end of 2025. CARVYKTI has demonstrated strong commercial potential, and the company is confident in advancing the product’s global launch with its partner Janssen, and further advancing it to the frontline. Peak annual sales of the CARVYKTI are expected to reach at least $5 billion.

In 2023, GenScript’s life science services and products segment continued to grow steadily, with improved profitability. External revenue exceeded $400 million, a year-on-year increase of 15.6%, and excluding the impact of currency fluctuations, the revenue growth at constant currency was about 16.4%. The company continued to leverage its strengths-molecular biology, protein and peptide grew at a faster pace, contributing to a higher percentage of overall revenue growth. Adjusted gross profit increased by approximately 11.6% year-on-year, reaching about $225 million. The adjusted gross margin for the life science was approximately 54.4%. Thanks to automation, lean projects and labor efficiency improvement, the life science gross profit margin remained stabilized. Notably, the adjusted operating profit of the life science business increased by approximately 19.4% year-on-year, reaching $78.3 million, which outpaced revenue growth. The adjusted operating profit margin increased to about 21% in 2H 2023, continuing a healthy trend of improvement in the last two years.

To help the company focus on innovation capacity building, the GenScript Scientific Advisory Board welcomed two world-renowned members—Dr. Carl June, an immunotherapy pioneer, Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania, and Dr. David R. Liu, a leader in genome editing, Professor at Harvard University, Broad Institute, and HHMI.

Bestzyme, GenScript’s industrial synthetic biologic product segment, achieved a year-on-year increase of 12.2% in external revenue, reaching about $42.9 million, and core enzyme portfolio constant currency revenue growth was about 22.6%.

The Bestzyme’s key account sales revenue contribution further improved by 4%. The newly launched innovative detergent enzyme showed steady growth in the last few quarters, and successfully earned industry-leading household product manufacturers as customers. In terms of product portfolio, Bestzyme has launched products with new features, and upgraded microorganism strains to increase production efficiency.

External revenue of the ProBio business achieved about $107 million in 2023, with a year-end cash position close to $260 million, ProBio has ample resources to execute the company’s business plans. ProBio recently received its first 2000L CMO order, marking a significant milestone for GenScript’s CDMO business. The experience from this project will enhance the company’s commercial manufacturing capabilities and strengthen the commercial quality systems, paving the way for the company to become a global CDMO.

Innovation Leads, Deepening Global Development

For a long time, GenScript has regarded innovation as the core competitive force driving corporate growth. It has not only achieved sustained high revenue growth for the group but also accomplished comprehensive development in the life science domain, continuously creating more value for customers. To support innovation, over 10% of the group’s workforce of more than 6900 global employees is dedicated to R&D. Their unwavering dedication has led to the accumulation of over 300 patents and 900 patent applications across the globe.

Innovation is also key to GenScript’s sustained development. In response to the increasing demand for CRISPR-related services and products, GenScript has launched a comprehensive suite for in vivo gene editing. The company’s offerings include editing tools, related enzymes, knock-in templates, library services, and cell line development. This platform enables the company’s clients to accelerate research in this field. In CGT-related instruments and consumables, the company also advanced its cell isolation platform CytoSinct and launched magnetic beads for NK/SA/CD4/CD8 cell separation, beads for T cell activation, and columns for cell separation.

Turnaround time is crucial to the company’s customers. GenScript not only accelerate customer projects by innovative solutions, but also by launching new platforms to shorten the company’s turnaround time. With launching GenSmart 2.0 online ordering platform to improve customer experience and simplify the ordering process. It has also combined TurboCHO 2.0 platform with high-throughput DNA synthesis platform, setting an industry-leading turnaround time of 5 business days for gene-to-protein services.

Currently, the Life Science has over 57,000 active global customers, with a significant increase in new customers compared to the same period last year, demonstrating continuous global recognition of its services and products. In 2024, GenScript expects the revenue of the life science to continue grow at a decent pace 15% to 20%, and gross profit margin to be around 55% plus or minus 1%. And the operating profit to grow faster than revenue.

Thanks to the Series A financing for Bestzyme last year, the company will further invest in its capacity to address manufacturing bottlenecks. Once finished the expansion project will increase its manufacturing capacity by 30-40%. In order to better address R&D needs for enzymes and synthetic biology, the R&D team of Bestzyme has expanded by about 20%.

In terms of the synthetic biologic pipeline, Bestzyme’s first 2 synthetic biology candidates, natural sweeteners and lactoferrin are making promising results throughout the year. The natural sweeteners and lactoferrin are expected to be launched in 2024 and 2025, respectively. Bestzyme will continue its growth trend in 2024. It is expected to have 20%-30% constant currency revenue growth for enzyme business lines, and gross profit margin to be around 39% plus or minus 1%. The anticipated operating profit margin to be close to 4-5%.

GenScript ProBio, has further enhanced its capabilities in protein and antibody drug and CGT platform and will continue to expand production scale to better serve global customers. At the same time, to support the global expansion, the company has invested resources in the quality management systems to ensure compliance with GMP regulations of the US FDA, EMA and NMPA. The company’s revenue in 2024 is expected to be flat compared to 2023. For ProBio, 2024 will be a year of investment. The Group will invest in commercial efforts, R&D and capacity to reaccelerate order growth.

In the field of cell therapy, Legend Biotech’s CARVYKTI has outperformed other CAR-T products in the market during the seven quarters of its launch. Cilta-cel has cumulatively treated over 2,500 patients. In 2023, Legend continued its efforts to support market penetration of CARVYKTI. At the same time, Legend Biotech continues to strengthen manufacturing capabilities to further meet market needs. Currently, the company’s new site in Ghent, has started clinical production, and the cell processing capacity has doubled compared to the beginning of 2023. In terms of capacity expansion, the company’s target is to support production capacity of 10,000 annual doses for CARVYKTI by the end of 2025. In pipeline updates, Legend Biotech’s BCMA-directed autologous therapy program, LB1908 targeting gastric cancer, and LB2103 project for treating multiple myeloma have made positive progress.

Sherry Shao, GenScript’s rotating CEO, said, "Despite market challenges in 2023, the Group achieved 34.2% revenue growth and a five-year CAGR of 30%. This achievement was made possible by continuing to create value for our customers through high-impact innovation and our dedicated global team.

Again, on behalf of the management team, I would like to express our gratitude to our customers for their continued trust in our services and products, to our employees for their unwavering dedication, and to our stakeholders for their faith in our vision and goals.

Looking ahead, we are excited about the opportunities ahead and will remain committed to innovation, improvement, and exceeding your expectations. Thank you all for being part of our journey towards continued growth and success."

Looking ahead to 2024, GenScript Group will continue to use innovation as the engine to deepen global operations, promote new development in various business segments, and create more value for customers and society. At the same time, the group will achieve profit growth that surpasses revenue growth through robust operations and efficient management, laying a solid foundation for future development. With the deepening of the globalization strategy and the strengthening of innovation capabilities, GenScript will embrace a broader development prospect.

Kinnate Biopharma Inc. Provides Statement on Silicon Valley Bank Receivership

On March 12, 2023 Kinnate Biopharma Inc. ("Kinnate") reported that it is aware of the recent events involving Silicon Valley Bank ("SVB") culminating in its placement into receivership with the Federal Deposit Insurance Corporation (Press release, Kinnate Biopharma, MAR 12, 2023, View Source [SID1234628543]).

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!

As of December 31, 2022, Kinnate had cash and cash equivalents and short-term and long-term investments of $240.6 million, of which $1.0 million was held in cash in deposit accounts at SVB (less than 1% of Kinnate’s cash and cash equivalents as of such date) and $239.6 million was held in accounts managed by third-party custodians. In addition, Kinnjiu Biopharma Inc. ("Kinnjiu"), now a wholly owned subsidiary of Kinnate, held $25.1 million in cash in deposit accounts at SVB. Additionally, Kinnate has $0.4 million of restricted cash held in a collateral account at SVB relating to the company’s office lease in San Diego.

Kinnate is seeking to minimize risk associated with the cash deposits held at SVB, including opening accounts with other banks, engaging a different asset manager and initiating transfers of funds from SVB to other banks.

Phase II clinical trial of ImmuneOnco Biopharmaceuticals IMM0306 completes first subject enrollment for dosing

On March 11, 2023 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the Phase II clinical trial of ImmuneOnco Biopharmaceuticals bispecific antibody-receptor recombinant protein drug (Project No. IMM0306), which targets both CD47 and CD20, was completed on 3rd April (Press release, ImmuneOnco Biopharma, MAR 11, 2023, View Source [SID1234655683]). This is another milestone achievement in the rapid development of ImmuneOnco Biopharmaceuticals.

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!

Previously, IMM0306 had obtained clinical trial approvals from China NMPA and US FDA, as well as patent authorizations from China, US, and Japan, solidifying ImmuneOnco Biopharmaceuticals’ leading position in the development of CD47 targeted drugs and bispecific antibodies research. On March 16th, following unanimous agreement from project research experts, IMM0306 selected a safe and effective single-agent dose of 2mg/kg to enter into the IIa phase of clinical trials, targeting further clinical development in indications for indolent lymphomas such as third-line and above follicular lymphoma (FL) and marginal zone lymphoma (MZL). At the same time, the Ib/IIa phase of clinical trials for IMM0306 in combination with lenalidomide for second-line diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma (FL) is also underway.

The preliminary data from the Phase I clinical trial has demonstrated encouraging efficacy and favorable safety profile of IMM0306. IMM0306 was safe and well tolerated up to 2.0 mg/kg. Among the evaluable patients across four cohorts dosed from 0.8 mg/kg to 2.0 mg/kg, who had relapsed or progressed after receiving rituximab previously, three CRs and four PRs were observed. Also, no significant cytokine storm toxicity was observed in all patients.

Dr. Wenzhi Tian, founder and chairman of ImmuneOnco Biopharmaceuticals, said:

"We are very pleased to see the first subject enrolled in our Phase II clinical trial of IMM0306, a recombinant antibody-receptor protein (mAb-Trap) targeting both CD47 and CD20 and is the first CD47 and CD20 dual-targeting bispecific to enter into clinical stage globally. IMM0306 does not bind to human erythrocytes in vitro and has been shown to be significantly more effective than rituximab at the same dose in preclinical in vivo efficacy trials. data from phase I clinical studies have demonstrated a favorable safety and clinical efficacy response as a single agent, with encouraging tumor efficacy observed particularly in patients with relapsed refractory FL and MZL and DLBCL. We will continue to advance the IMM0306 program and strive to bring early benefits to the majority of cancer patients."

Immix Biopharma Confirms No Exposure to Silicon Valley Bank or Silvergate Bank

On March 11, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that neither ImmixBio, nor any of its subsidiaries, have any exposure to Silicon Valley Bank ("SVB") or Silvergate Bank (Press release, Immix Biopharma, MAR 11, 2023, View Source [SID1234628546]).

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!