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BUSINESS INSIGHTS

Asymchem and LaNova Medicines Enter into Partnership Agreement, Expanding Biological Capabilities

Asymchem | September 17, 2021

Asymchem today announced a strategic partnership agreement to provide LaNova Medicines with one-stop services such as small molecule drugs, ADC project CMCs, R&D, production and IND China-US declaration.

The collaboration between Asymchem and LaNova will include small molecule drugs, monoclonal antibodies, double antibodies, ADC projects and potentially other R&D and production initiatives. This partnership will take full advantage of Asymchem's recently completed biological CDMO service platform and production base at Shanghai Jinshan, where Asymchem is already undertaking R&D and production services for a number of early IND and clinical phase projects of biological drugs. The platform can provide R&D and production services including monoclonal antibodies, double antibodies, and ADC drugs.

With the advent of the ADC drug research and development wave, ADC-related businesses have exploded, In the future, we expect to build ADC pilot and commercial production facilities to further enhance Asymchem's capabilities with ADC drugs.

- Asymchem Chief Operating Officer (COO) Yang Rui, who attended the signing ceremony in Shanghai.

Antibody-drug conjugates (ADCs) are a highly promising class of targeted drugs in which drug molecules are linked to antibodies that selectively attach to the surface of cancer cells while avoiding effects on nearby healthy cells, dramatically reducing side effects. More than 100 clinical trials are underway studying the effectiveness of ADCs in treating blood, lung, breast, brain and other cancers.

Rui said the partnership was a logical next step for Asymchem as the CDMO continues to expand its capabilities and service into new business areas to offer pharmaceutical and biotech companies innovative and sustainable solutions.

About Asymchem
Founded in 1999, Asymchem stock code: 002821.SZ) is a leading global integrated Contract Development and Manufacturing Organization (CDMO) providing innovative drug R&D and manufacturing. Asymchem is supported by more than 5,000 employees based in PR China, the US, and the EU. Our mission is to drive efficiency through continuous technological advances for smarter, greener and more cost-effective manufacturing to support pharmaceutical clinical research and commercialization, backed by a proven track record of successful agency and industry inspections.

About LaNova Medicines
Based in Shanghai, LaNova Medicines is a clinical-stage R&D company whose primary focus is the development of macromolecular anti-tumor drugs utilizing GPCRs for monoclonal antibody production. The company's comprehensive platform capabilities include target verification, antibody engineering, production technology, preclinical and clinical research.

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BUSINESS INSIGHTS, PHARMACY MARKET

AustinPx Expands Development and Manufacturing Technologies

Businesswire | May 10, 2023

AustinPx, a contract development and manufacturing organization (CDMO) specializing in analytical and formulation development services and cGMP manufacturing for small molecule drugs, today announced the expansion of its capabilities to meet industry demand for the Company’s services and expertise. The Company has added new spray drying and encapsulation capabilities and has also expanded its GMP manufacturing capacity for high shear and fluid bed granulation. AustinPx has installed and validated a Dott. Bonapace INCAP capsule filler, a Freund-Vector VFC3 model fluid bed, and a Freund-Vector GMXB-Pilot model granulator. The INCAP rounds out the Company’s solid dose manufacturing capabilities, while the fluid bed and granulator supplement the Company’s manufacturing scale. “The investments are a key component of AustinPx’s larger strategy to expand our oral dose development and manufacturing capabilities to better serve our clients’ increasing demand,” said Justin Keen, PhD, senior vice president operations. “The additions demonstrate our ongoing commitment to providing our clients with the best possible service and support." In line with the Company’s mission of providing science-driven formulation development, AustinPx has installed a PROCEPT modular 4M8-Trix for the development of spray dried amorphous solid dispersions. The addition supplements AustinPx’s current portfolio of bioavailability enhancement technologies, including KinetiSol® Technology - the Company’s proprietary fusion-based amorphous dispersion manufacturing platform. “We are excited to add spray drying to our portfolio,” said Dave Miller, PhD, chief scientific officer. “When combined with our existing formulation capabilities, the addition enables us to provide a comprehensive suite of bioavailability enhancement solutions to identify the optimal formulation pathway for poorly soluble compounds and address a greater number of our clients’ challenges.” The expanded capabilities are now available for use. These additions are the first of several strategic investments planned for the Company in the immediate future, as AustinPx continues to position itself as a leading CDMO in the pharmaceutical industry. About AustinPx AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

PHARMA TECH

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

Globenewswire | June 01, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma. “The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.” The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST. “This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.” About Ciltacabtagene Autoleucel (cilta-cel) Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5 Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9 In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10 About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13 About the Janssen Pharmaceutical At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

PHARMACY MARKET

Athenex, Inc. Reaches Agreement With Lenders to Pursue Expedited Sales Process

Globenewswire | May 16, 2023

Athenex, Inc. a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that, following an ongoing strategic review, it has reached agreement with its lenders to move forward with an expedited sales process of the Company’s assets across its primary businesses: Athenex Pharmaceutical Division (“APD”), Orascovery, and Cell Therapy. To best facilitate this process, Athenex and certain of its subsidiaries filed voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas. This will enable the Company to divest its assets and wind down the Athenex platform in an orderly fashion, while seeking to maximize value for its stakeholders. The Company anticipates concluding the expedited sales process by July 1, 2023, with the Chapter 11 cases continuing thereafter to resolve claims. Athenex has also reached an agreement with its secured lenders, subject to court approval, for the consensual use of cash collateral, which will enable the Company to, among other things, satisfy certain obligations to its vendors for authorized goods received and services rendered after the filing. Athenex Pharma Solutions (“APS”), which includes the Company’s manufacturing facility in Clarence, New York, is expected to continue its operations for at least the next 90 days, to provide commercial supply of tirbanibulin ointment. In addition, APD is continuing to operate in the ordinary course and fill customer orders with the ample inventory it has on hand. Dr. Johnson Lau, Chief Executive Officer of Athenex, on behalf of the management team and the Athenex Board of Directors, said, “Throughout our history, we have sought to become a leader in bringing innovative cancer treatments to the market and improving patient health outcomes. Our team was successful in bringing tirbanibulin, through regulatory approvals, to the U.S. market and a number of EU countries, as well as Taiwan. Unfortunately, our oral paclitaxel product candidate received a complete response letter from the U.S. Food and Drug Administration, and this significant regulatory setback, coupled with challenging biotech markets and the difficult economic environment, put tremendous pressure on our ability to continue to fund our businesses. “Over the past two years, we made considerable progress in refocusing our business around our promising NKT cell therapy platform, monetizing non-core assets to improve our balance sheet and extending our cash runway, paying down $108 million of debt, and undertaking a comprehensive review of strategic alternatives to create value for our stakeholders. While we explored every viable avenue to avoid this outcome, an orderly sales process represents the best path forward at this time. “Our goal remains to identify purchasers who will continue development of the important drug candidates for which we have established a good foundation, and to bring them to market on behalf of medical practitioners and, most importantly, for patients. We are incredibly thankful to our team for their dedication to Athenex and will look to support our colleagues through this transition period.” Pachulski Stang Ziehl & Jones LLP is acting as Athenex's legal counsel. MERU is serving as its financial advisor and Cassel Salpeter & Co., LLC as its investment banker. About Athenex, Inc. Founded in 2003, Athenex, Inc. is a clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next-generation cell therapy products for the treatment of cancer. The Company’s mission is to become a leader in bringing innovative cancer treatments to the market and to improve patient health outcomes. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company is focused on its innovative Cell Therapy platform, based on natural killer T (“NKT”) cells.