On March 28, 2023 -Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, reported that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF) (Press release, Sino-American Cancer Foundation, MAR 28, 2023, View Source [SID1234629474]). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design (AIDD) technology in the ADMET Predictor software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target.

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Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved.

"We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes," said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. "By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities."

As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met.

"SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research," added Dr. Frank Luh, CEO of SACF. "Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer."

John DiBella, SLP Division President, said, "The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.

On March 28, 2023 Biocom California, the association representing the life science industry of California, reported the following statement regarding their application to intervene in support of Illumina’s challenge to the European Commission’s jurisdiction over the acquisition of GRAIL (Press release, Illumina, MAR 28, 2023, View Source [SID1234629473]). The statement can be attributed to Joe Panetta, Biocom California’s president and CEO:

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"The European Court of Justice has granted Biocom California’s application to intervene in support of Illumina’s challenge to the European Commission’s jurisdiction over the acquisition of GRAIL. As the court recognized, Biocom California has a ‘direct, existing interest in the outcome’ of the case. The EU’s expanded approach to reviewing mergers, if upheld by the court, will make it more difficult for small, new and growing businesses to find investors, due to the unpredictability inherent in the new interpretation. Innovation in the life sciences will suffer as a result. The acquisition of GRAIL will allow Illumina to accelerate the availability and affordability of GRAIL’s multi-cancer early detection test, transforming the landscape of cancer detection on a global scale and ultimately save lives. As a leader and advocate for more than 1,700 life science companies, Biocom California strongly believes enabling this acquisition would ensure the growth and development of our innovation ecosystem, and ultimately improve the lives of patients.

On March 28, 2023 iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, reported that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA) (Press release, iOnctura, MAR 28, 2023, View Source [SID1234629472]).

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The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market and thereby patient access to novel treatments in the UK. Reserved for innovative therapies for life-threatening or seriously debilitating conditions, ILAP provides applicants with a toolkit to support all stages of the design, development, and approval process.

Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumor proliferation and breaks immune tolerance in patients with solid and hematological tumors.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Innovation Passport is an exciting step in the clinical development programme for roginolisib, a drug with a game-changing clinical safety and activity profile. Being awarded this passport will allow us to work closely with the MHRA and its partner agencies to chart out a roadmap for regulatory and key development milestones with the primary goal of achieving early patient access to roginolisib."

PI3Kδ inhibition in solid tumors has recently emerged as a novel approach to treating cancer because of its potential in targeting multiple tumor survival pathways. First-generation PI3Kδ inhibitors are used to treat hematological tumors, but safety concerns and limited target selectivity have curbed their clinical usefulness. These concerns are even more aggravated in patients with solid malignancies where rapid onset of toxicities have been observed. In contrast, roginolisib has a favorable toxicity profile with less than 5% Grade 3/4 toxicities at the biologically effective dose in clinical studies. Importantly, these toxicities have to-date been transient in nature without the need for dose reductions.

Clinical activity, including partial and complete responses, are being seen in patients with both solid and hematologic malignancies. Further details on clinical responses will be released at a future international clinical conference in 2023. Fourteen of 43 patients (including 12 of 28 uveal melanoma patients) are still on treatment, with two patients having been on treatment for more than two years. The one-year OS rate is currently 70%; median OS has not been reached.

A research paper recently published in Cancer Research Communications highlights that roginolisib has immune-modulatory properties that can be exploited in solid tumors and further reinforced the conclusion that roginolisib inhibits regulatory T cell proliferation while having limited anti-proliferative effects on conventional CD4+ T cells and no effect on CD8+ T cells; both immune cell types key to a robust immune response to tumors. You can access the link to the paper here.

On March 28, 2023 OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP") (Press release, Quest PharmaTech, MAR 28, 2023, View Source [SID1234629471]).

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According to the terms of the agreement, OncoVent agreed to grant exclusive rights to OEP, which will be responsible for the commercialization of oregovomab, an immunotherapy drug candidate, in Taiwan, including related regulatory applications and necessary clinical trials. OncoVent is entitled to a number of payments from OEP under the license agreement, including a one-off non-refundable upfront payment upon the effective date of the license agreement, multiple regulatory milestone payments, and multiple commercial milestone payments, in a total transaction amount of up to US$11.2 million. OEP also agreed to purchase oregovomab from OncoVent at a price equal to an agreed percentage to the average sale price of oregovomab in Taiwan.

In addition, OncoVent granted OEP the right of first refusal for the exclusive sales, marketing, and distribution right in Hong Kong and Macau.

Oregovomab, a murine monoclonal antibody and a first-in-class anti-CA125 immunotherapy drug candidate, is currently being evaluated in a global Phase III trial using study drugs produced by Cytovance Biologics Inc, a wholly-owned subsidiary of the Company and a leading contract development and manufacturing organization (CDMO) serving the biopharmaceutical industry.

Prior to this, a Phase II clinical study of oregovomab in combination with standard chemotherapy for the first-line treatment of patients with advanced primary ovarian cancer was already completed. Results from the Phase II clinical trial showed that the safety and efficacy of the combination in patients with advanced primary ovarian cancer were in line with expectations, with the median progression-free-survival (PFS) of the oregovomab plus chemotherapy cohort significantly improved to 41.8 months, compared with 12.2 months with the chemotherapy-only regimen, with a hazard ratio (HR) of 0.46 (95% confidence interval [CI]: 0.28, 0.77). It also showed a significant improvement in overall survival (OS) with an HR of 0.35 (95% Cl: 0.16, 0.76).

Ovarian cancer is ranked the eighth most common cancer in women globally and the first-line treatment for this disease has not changed for many years. Oregovomab has obtained Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The first patient in a Phase III clinical trial of oregovomab was dosed in the U.S. in 2020. This global pivotal trial is expected to enroll 602 patients from 190 clinical sites in 17 countries and regions. As of the date of the announcement, the Phase III clinical trial of oregovomab has enrolled 534 subjects globally, of which 21 subjects are from Taiwan.

Mr. Calvin Tsai, Chief Executive Officer of OEP, said, "we have been actively expanding our oncology portfolio through R&D collaborations and in-licensing, in order to address unmet medical needs in a broad range of tumor types and bring renewed hope to cancer patients in the Asia Pacific region. Hepalink is a leading multinational biopharmaceutical company dual-listed in Hong Kong and mainland China. Its subsidiary, OncoVent, possesses a monoclonal antibody (mAb) technology platform and advanced biotechnologies for the development of oncotherapeutic vaccines and immuno-oncologic combination therapies. It is our pleasure to enter into this collaboration with Hepalink. We believe oregovomab can potentially improve the treatment outcomes for patients with advanced primary ovarian cancer. This collaboration with OncoVent not only strengthens our oncology portfolio, but also serves our overarching objective of advancing oncologic therapeutics."

Ms. Tao Han, Chief Business Officer of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. and Chief Executive Officer of OncoVent Co., Ltd, commented, "having established itself in the oncology field for over 20 years, OEP is a multinational pharmaceutical company with integrated capabilities in R&D, manufacturing and commercialization, as well as a highly experienced team in the Asia Pacific region. We are glad to have entered into this strategic agreement with OEP as it will allow us to jointly develop and commercialize oregovomab, a candidate drug with promising therapeutic potential, and explore the drug’s additional therapeutic utility for a broader population of cancer patients. Moving forward, Hepalink will continue to seek partnering opportunities to accelerate the expansion of its innovative drug business and develop a diverse range of commercial capabilities.

On March 28, 2023 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma" or "the Group", Stock Code: 600196.SH; 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China, announced its 2022 annual results today (the "Reporting Period") (Press release, Fosun Pharma, MAR 28, 2023, View Source [SID1234629470]).

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The revenue from new products and sub-new products including Han Li Kang, Han Qu You, Comirnaty, Jie Bei An, Su Ke Xin, Han Si Zhuang accounted for more than 30% of the revenue from the pharmaceutical manufacturing segment, and the revenue structure continued to be optimized;
The revenue from new products and sub-new products including Han Li Kang, Han Qu You, Comirnaty, Jie Bei An, Su Ke Xin, Han Si Zhuang accounted for more than 30% of the revenue from the pharmaceutical manufacturing segment, and the revenue structure continued to be optimized;
During the Reporting Period, Fosun Pharma achieved steady business growth, mainly driven by the revenue growth from new and sub-new products and the effective control of sales expenses. In 2022, Fosun Pharma achieved a revenue of RMB 43.952 billion, with a year-on-year growth of 12.66%; the net profit after deducting extraordinary gain or loss attributable to shareholders of the listed company was RMB 3.873 billion, with a year-on-year growth of 18.17%; the net cash flow from operating activities was RMB 4.218 billion, with a year-on-year growth of 7.1%. The Company has achieved remarkable results in R&D innovation and transformation, and the international operation capability was further improved to achieve long-term sustainable development.

Continuously Increased R&D Investment with Remarkable Results in Innovation and Transformation

Fosun Pharma is a patient-centered, clinical demand-oriented, and innovative R&D driven company. Through independent R&D, cooperative development, licensing introduction, and in-depth incubation, Fosun Pharma continued to enrich innovative product pipelines, improved the research and clinical development ability of FIC (First-in-class) and BIC (Best-in-class) drugs, and accelerated the research, development, and transformation of innovative technologies and products.

Focusing on core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease), Fosun Pharma continued to increase its investment in innovative R&D, with a total R&D expenditure of RMB 5.885 billion for the year, with a year-on-year growth of 18.22%, among which, the R&D expenses amounted to RMB 4.302 billion, with a year-on-year growth of RMB 0.465 billion or 12.12%. The R&D expenditures in the pharmaceutical manufacturing business amounted to RMB 5.097 billion, with a year-on-year growth of 13.62%, and the R&D expenditures in the pharmaceutical manufacturing business accounted for 16.54% of the revenue from the pharmaceutical manufacturing business, among which, the R&D expenses amounted to RMB 3.552 billion, accounting for 11.53% of the revenue from the pharmaceutical manufacturing business.

During the reporting period, 6 self-developed innovative drugs (indications), 4 license-in innovative drugs (indications), and 27 generic drugs (indications) of Fosun Pharma were approved for launch in Chinese Mainland/Hong Kong, China/United States; 7 innovative drugs (indications) and 30 generic drugs (indications) had applied for launch (NDA) in Chinese Mainland; and 22 innovative drugs (indications) were approved for clinical trials (IND) in Chinese Mainland.

In 2022, multiple innovative products and indications of Fosun Pharma were approved for launch, benefiting more patients worldwide. Among them, Fosun Pharma’s first self-developed biopharmaceutical innovative drug, Han Si Zhuang (Serplulimab Injection), has been successively approved for three indications, Microsatellite Instability-high (MSI-H) solid tumors, Squamous Non-small Cell Lung Cancer (sqNSCLC) and Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Chinese Mainland; the indication of Small Cell Lung Cancer (SCLC) was granted with Orphan Drug Designation by the U.S. FDA and the European Commission (EC). The innovative indication Rheumatoid Arthritis (RA) of Han Li Kang (Rituximab injection) has been approved for launch and included in the 2022 National Reimbursement Drug List.

Both the monovalent COVID-19 vaccine COMIRNATY (30 mg per dose) (also known as BNT162b2 or COMIRNATY Original) and COMIRNATY Original/Omicron BA.4/BA.5 bivalent COVID-19 vaccine (also known as COMIRNATY Bivalent COVID-19 Vaccine) were officially registered in Hong Kong SAR and approved as a regular imported vaccine by the Macao SAR. The related dosage forms for children and infants have also been granted the Emergency Use Authorization (EUA) in Hong Kong SAR and Macao SAR, respectively, and included in the local immunization programs; Azvudine Tablets jointly developed by Fosun Pharma and Genuine Biotech obtained the emergency use authorization from the National Medical Products Administration in July 2022 for use in the treatment of adult COVID-19 patients with moderate symptoms.

Keverprazan Hydrochloride Tablets (trade name: Bei Wen), the first potassium ion competitive acid blocker (P-CAB) independently developed in China, jointly developed by the Group and Carephar and exclusively commercialized by the Group, was approved for launch in Chinese Mainland in February 2023 for the treatment of duodenal ulcer (DU) and reflux esophagitis (RE); Han Qu You (Trastuzumab for Injection), independently developed by Fosun Pharma and licensed to Cipla, has been approved for launch in Australia, and its approved indications cover all approved indications of the branded drug in the local market.

As the first CAR-T cell therapy product approved for domestic launch, Yi Kai Da (ejilunsai injection) from Fosun Kite, the cell therapy platform of Fosun Pharma, was further improved in drug accessibility. As of the end of 2022, Yi Kai Da has been included in the urban customized commercial health insurance of 70 provinces and municipalities and over 60 commercial insurances, while the number of treatment centers on record ~exceeded 130. As of the end of January 2023, nearly 300 patients with relapsed or refractory large B-cell lymphoma lymphoma had been treated with Yi Kai Da.

As of the end of the Reporting Period, the revenue from new and sub-new products accounted for more than 30% of the revenue from the pharmaceutical manufacturing business, which is mainly due to the revenue contribution of newly launched products, namely Han Si Zhuang and Jie Bei An, as well as the growth contribution of sub-new products, namely Han Qu You and Su Ke Xin, promoting the sustained and steady growth of business.

Adhered to Globalization with Continuously Improvement in Global Operation Capability

Relying on years of industrial experience, investment in innovative R&D and expanding of global channel network, Fosun Pharma has the industry-leading global two-way licensing capability to maximize the value of self-developed products and cooperative innovative products. During the Reporting Period, Fosun Pharma’s revenue outside the Chinese Mainland and other countries amounted to RMB 13.938 billion, accounting for 31.71%.

In 2022, Fosun Pharma and Amgen’s subsidiary formed collaboration on the exclusive licensing to commercialize two innovative drugs, namely Otezla (Apremilast Tablets) and Parsabiv (Etelcalcetide) in Chinese Mainland (excluding Hong Kong SAR, Macao SAR, and Taiwan region), further enriching Fosun Pharma’s innovative product layout in the non-tumor field; Shanghai Henlius, a subsidiary, successively granted a number of product licenses to Getz Pharma, Eurofarma, Abbott, Organon, and other companies in order to cover the incremental markets with the help of international leading partners. In addition, Gland Pharma, a subsidiary, proposed to acquire Cenexi, a European CDMO company, with a maximum total amount payable of up to EUR210 million, so as to strategically lay out its CDMO business in the European market and construct localized manufacturing capacity in Europe.

Fosun Pharma has taken the United States as a breakthrough in overseas markets, actively promoted the launch of generic drugs and Han Si Zhuang (Serplulimab Injection), and continuously improved the commercialization capacity in the U.S. market. At the same time, Tridem Pharma and Gland Pharma have established their own sales teams in Africa and India respectively, and will further improve the promotion and sales of products in other emerging markets in the future.

Continuous R&D Innovation for the Benefit of the Public and Active Practice of Social Responsibility

R&D innovation is the most important responsibility for Fosun Pharma’s sustainable development. Over the years, Fosun Pharma has adhered to R&D innovation, with a number of innovative achievements continuously implemented and a number of innovative drugs and new indications included in the latest version of the National Medical Insurance Drug Catalogue, further improving the accessibility and affordability of innovative drugs and benefiting more patients in China.

At the same time, Fosun Pharma has also given full play to its own advantages and vigorously promoted the construction of basic medical and health systems in developing countries and underdeveloped areas to help solve the problem of drug accessibility. In 2022, a subsidiary of Fosun Pharma was licensed under MPP to produce and supply two high-quality and affordable oral COVID-19 drugs to low- and middle-income countries in the globally agreed regions; as of the end of 2022, Fosun Pharma’s Artesun (Artesunate for Injection), a self-developed antimalarial innovative drug, was adopted to treat more than 56 million severe cases of malaria worldwide.

Fosun Pharma received many awards for its outstanding performance in ESG management, social responsibility, and other sustainable development fields. In 2022, Fosun Pharma was upgraded to A level in the ESG rating published by MSCI, an international index authority. Fosun Pharma has released CSR reports for 15 consecutive years to show stakeholders its practices and achievements in the field of social responsibility. Experts of the rating team of the China CSR Report Rating Expert Committee are of the view that Fosun Pharma’s CSR report is excellent and has awarded the Company with a five-star rating.