Levena Biopharma US, Inc.

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Cytotoxic Drugs and HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies, Europe, Asia-Pacific and Rest of the World: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering. "Cytotoxic Drugs and HPAPI Manufacturing Market 2022-2035" report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth. Frequently Asked Questions What are the current opportunities within the HPAPI and cytotoxic drug market? The cytotoxic drugs and HPAPI manufacturing market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain? The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain? Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment. What are the key challenges faced by HPAPI and cytotoxic drug CMOs? The primary challenge faced during the manufacturing of highly potent APIs and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds. What are the key value drivers in the HPAPIs and cytotoxic drugs contract manufacturing market? The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players. How is the revenue generation potential associated with cytotoxic drugs and HPAPI manufacturing market likely to evolve in the coming years? The cytotoxic drugs and HPAPI manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term. The report features detailed transcripts of interviews held with the following individuals: Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals) Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent) Roberto Margarita (Business Development Director, CordenPharma) Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics) Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research) Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare) Allison Vavala (Ex-Senior Manager, Business Development, Helsinn) Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) Javier E. Aznarez Araiz (Ex-Business Development, Idifarma) COMPANY COMPETITIVENESS ANALYSIS HPAPI Contract Manufacturers: Company Competitiveness Analysis Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA AbbVie Cambrex Catalent Pfizer CentreOne Piramal Pharma Solutions COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE Abzena Aenova CARBOGEN AMCIS Hovione Lonza COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF THE WORLD Intas Pharmaceuticals Scinopharm STA Pharmaceutical (a WuXi AppTec company) Syngene Teva API LIST OF COMPANIES AND ORGANIZATIONS AbbVie Abzena ACES Pharma Adare Pharma Solutions ADC Biotechnology ADC Therapeutics ADIENNE Pharma and Biotech Aenova AGC Pharma Chemicals (A subsidiary of AGC Group) Agno Pharma AIMEDBIO Ajinomoto Bio-Pharma Services ALB Technology Alcami Alkermes Almac Alphora Research Altasciences Alvogen Amneal Pharmaceuticals AMPAC Fine Chemicals (A SK pharmteco company) Angelini Fine Chemicals (A subsidiary of Angelini Pharma) ANI Pharmaceuticals Antengene ANVI Pharma Aptuit (An Evotec company) Ardena Arevipharma (Acquired by Yonsung Group) Aspen API Astellas Pharma Astorg AstraZeneca Asymchem Laboratories Aurigene Pharmaceutical Services Avra Laboratories (Acquired by Advent International) Baxter BioPharma Solutions Bio-Synthesis BioTechnique BioVectra BiVictriX Therapeutics BOC Sciences Boehringer Ingelheim Bolt Biotherapeutics Boryung Pharmaceutical Bright Peak Therapeutics Bristol Myers Squibb BrYet Health Bryllan BSP Pharmaceuticals Bushu Pharmaceuticals Byondis Cambrex Capsugel (A Lonza company) CARBOGEN AMCIS (A Dishman Carbogen Amcis Group company) Catalent CellMosaic Celon Laboratories Cerbios-Pharma ChemCon ChemPartner CordenPharma CoreRx Creative Biolabs CritiTech Curia Custom Pharmaceutical Services (A part of Dr. Reddy's Laboratories) Cytopharma Daiichi Sankyo Dalton Pharma Services Dipharma Divi's Laboratories DOTTIKON EXCLUSIVE SYNTHESIS EirGen Pharma (Acquired by OPKO Health) Eisai Eli Lilly Enteris BioPharma (A subsidiary of SWK Holdings) Esteve Eurofins Scientific EVER Pharma Excella (Acquired by Fareva) Exelixis Fabbrica Italiana Sintetici Fareva Farmabios (A PharmaZell Group company) Farmhispania Femtogenix Fermion (A subsidiary of Orion) Flamma Formex (A subsidiary of Biotech Investment Group (BIG)) Formosa Laboratories Fresenius Kabi Frontida BioPharm (Acquired by Adare Pharma Solutions) Fujimoto Chemicals GeneQuantum Healthcare Genmab GENTEC PHARMACEUTICAL GROUP Gilead Sciences Glycotope Goodwin Biotechnology GP Pharm GTP Bioways Gustave Roussy Helsinn Advanced Synthesis Heraeus Hovione ICROM Idifarma (Acquired by Ardena) IDT Australia Iksuda Therapeutics ImmunoGen Indena Ind-Swift Laboratories Intas Pharmaceuticals Janssen Biotech Kodiak Sciences Kohlberg Kyongbo Pharmaceutical (A subsidiary of Chong Kun Dang Pharmaceutical) LakePharma Laurus Synthesis LegoChem Biosciences Levena Biopharma (A subsidiary of Sorrento Therapeutics) Lonza Lotus Pharmaceuticals Lubrizol Life Science MabPlex Mac-Chem (A NMS Group Company) Magle Chemoswed Malladi Drugs & Pharmaceuticals Mayne Pharma McSAF MEDICHEM Merck Mersana Therapeutics Metrics Contract Services MilliporeSigma Minafin Minakem (A subsidiary of Minafin) Mitsubishi Tanabe Pharma Mubadala MuseChem Natco Pharma Navrogen NBE-Therapeutics NerPharMa NJ Bio Normon Novartis Novasep Oasmia Pharmaceutical OEP Pharma Olon Oncotec Pharma Produktion Oxford BioTherapeutics Parabolic Drugs Patheon (Acquired by Thermo Fischer Scientific) PCI Pharma Services Pensatech Pharma Pfanstiehl Pfizer Pfizer CentreOne Pharmacare Premium Pharmaceutics International Pharmascience PharmaZell PILA PHARMA Piramal Pharma Solutions PrasFarma Procos (A subsidiary of CBC) ProJect Pharmaceutics Pyxis Oncology Quadira Biosciences Quotient Sciences Recipharm Recro Pharma Regis Technologies RemeGen Richman Chemical SafeBridge Consultants (Acquired by Trinity Consultants) Sai Life Sciences Sanofi Sartorius ScinoPharm Taiwan Seagen Seattle Genetics SEQENS (Acquired by SK Capital Partners) Shionogi Pharma Siegfried Sigma-Aldrich Fine Chemicals (SAFC) (a Sigma-Aldrich company) SK biotek SK Capital Societal CDMO Sofpromed Somatek SOTIO Biotech STA Pharmaceutical (A WuXi AppTec company) Stason Pharmaceuticals Sterling Pharma Solutions Sutro Biopharma Swedish Orphan Biovitrum (SOBI) SWK Holdings Symbiosis Pharmaceutical Services Synaffix Synbias Pharma Syngene Synthon TBD-Biodiscovery Tergus Pharma Teva API TRIO Pharmaceuticals Tubulis University of Goettingen UPM Pharmaceuticals Vectura Veranova VERAXA Biotech VUAB Pharma (A SAFICHEM company) VxP Pharma Wavelength Pharmaceuticals (A subsidiary of SEQENS) WuXi Biologics ZNZ Pharma For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

A166 is an antibody-drug conjugate (ADC) composed of an anti-HER2 antibody conjugated to Duostatin-5, a novel anti-microtubule Auristatin derivative, via a proprietary stable covalent linker.The ASCO meeting presentation (ASCO Poster# 415) includes A166 dose expansion data administered in 3-week cycles at doses of 4.8 mg/kg or 6.0 mg/kg in a total of 58 female patients with HER2-positive breast cancer.The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort, respectively.Median PFS was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort, respectively.Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months. CHENGDU, China, and SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) -- Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma (“Levena”), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO, the American Society of Clinical Oncology, to be held on June 3-7 in Chicago, IL. A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker. As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)]. At the upcoming 2022 ASCO meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles. The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO meeting. About Sichuan Kelun-Biotech Biopharmaceuticals, Co. Ltd.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., founded in 2016. Kelun-biotech is committed to developing, and commercializing innovative drugs for the treatment of cancer, autoimmune and other diseases with unmet medical needs. Kelun-Biotech has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), and clinical development capabilities. Leveraging the platform, the company has built a robust pipeline, 1 I/O monoclonal antibody asset in NMPA NDA stage, 3 assets (including 1 monoclonal antibody and 2 ADCs) in Phase 3 or pivotal clinical trials, and an additional 10 molecules in clinical studies. For more information, please contact: China: klbio_bd@kelun.com, US: bd@kluspharma.com About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic test solutions, including COVIMARK™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com Forward-Looking StatementsThis press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding A166, an anti-HER2 ADC; the therapeutic and clinical potential of A166; the potential safety and efficacy of A166, including A166’s potential efficacy against HER2-positive breast cancer; and the potential advantages of A166 over its competitors. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to safety and efficacy for A166; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law. Media and Investor RelationsContact: Brian CooleyEmail: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2022 Sorrento Therapeutics, Inc. All Rights Reserved.

The list of FDA approved antibody drug conjugates (ADC) is growing, and more drugs of this type are on the way in the pipelines of several companies. On Thursday, two more biotech startups joined the mix, unveiling a combined $112 million to advance their respective programs. Of the two companies, Copenhagen, Denmark-based Adcendo had the bigger investment, closing a €51 million (about $62 million) Series A round of financing. Adcentrx, which splits its operations between Shanghai and San Diego, raised $50 million in its Series A round. ADCs are comprised of a targeting antibody linked to a powerful, cancer-killing compound. These drugs are intended to deliver to cancer cells a targeted strike that spares healthy tissue. Adcendo’s approach is reflected in its name. The company is developing ADCs that target endocytic receptors, which play a role in the process by which substances are brought into a cell. The company’s first target is urokinase plasminogen activator receptor-associated protein, or uPARAP. This protein is overexpressed on the cell surface of several types of cancers, and by targeting it, the company aims to use it as a “drug internalization pump” that essentially brings the drug into the cancer cell. Adcendo said its approach could enable its drugs to better direct the drug delivery of its payload to cancer cells, ensuring that healthy tissue do not take up the toxic compound. The uPARAP protein has been found on soft-tissue sarcoma, osteosarcoma, glioblastoma multiforme, triple-negative breast cancers, and certain forms of leukemia. Adcendo claims to be the first company to demonstrate targeted drug delivery to uPARAP. Adcendo was founded in 2017 by Niels Behrendt, Lars Henning Engelholm, and Christoffer Nielsen from The Finsen Laboratory of Rigshospitalet and the University of Copenhagen, and Henrik Stage, a biotech entrepreneur who was previously an executive at Santaris Pharma, which Roche acquired in 2014. The startup spun out of the university and initially operated within BioInnovation Institute, an incubator formed by the Novo Nordisk Foundation. Novo Seeds, an early-stage investment firm created by Novo Holdings and Ysios Capital, led Adcendo’s Series A financing. Other investors in the round include RA Capital Management, HealthCap and Gilde Healthcare. In a prepared statement, John Haurum, chairman of Adcendo’s board, said that the new cash enables the startup to bring its first program to proof-of-concept human testing. In addition to the uPARAP program, Adcendo is building a pipeline of more ADC therapies. Adcentrx is led by founder and CEO Hui Li, the former chief executive of Levena Biopharma, the ADC subsidiary of Sorrento Therapeutics. The startup provided no information about its programs, and though the company touts its ADCs as “next generation,” the company did not say what its drugs are targeting or how they would be different than ADCs currently available or in development. Besides the protein targeted by the antibody, ways that ADC developers have distinguished their therapeutic candidates include the toxic payload carried by these drugs or the chemical linkers used to conjugate that payload to the antibody. The type of linker used affects how the payload is deployed once the drug reaches cancer cells. Adcentrx did not respond to an email query. In a prepared statement. Li said the financing gives the company the ability to advance multiple discovery and development programs. The company’s financing was led by CBC Group. Zoo Capital, the venture arm of Boyu Capital, also participated. A total of 10 ADCs have passed FDA muster, all of them for cancer. These approved therapies include products from Seagen, Pfizer, Roche, AstraZeneca, and GlaxoSmithKline. The newest ADC comes from ADC Therapeutics, which last week won FDA approval for loncastuximab tesirine (Zynlonta), a therapy for diffuse large B-cell lymphoma. Public domain image by the National Cancer Institute