Ionis to present at upcoming investor conferences

On August 30, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported that management will participate in fireside chats at the following investor conferences (Press release, Ionis Pharmaceuticals, AUG 30, 2022, View Source [SID1234618794]):

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2022 Wells Fargo Healthcare Conference on Wednesday, September 7, 2022
Citi’s 17th Annual BioPharma Conference on Thursday, September 8, 2022
Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022
A live webcast and additional information about each fireside chat can be accessed on the Investors & Media section of the Ionis website at www.ionispharma.com. Replays will be available on the Ionis website within 48 hours of each event.

Fosun Pharma Announces 2022 Interim Results

On August 30, 2022 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, reported its interim results for the first half of 2022 (Press release, Fosun Pharma, AUG 30, 2022, View Source [SID1234618793]).

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In the first half of 2022, Fosun Pharma achieved stable growth in revenue and recurring income. The proportion of revenue from new and sub-new products and the revenue from countries and regions outside Chinese mainland continued to increase, and the revenue structure constantly improved. During the reporting period, the revenue of the Group amounted to RMB2,1340 million, an increase of 25.88% YOY; net profit (after extraordinary gain or loss) attributable to shareholders of the listed company amounted to RMB1,862 million, an increase of 18.57% YOY; net cash flow from operating activities amounted to RMB 1,820 million, an increase of 6.66% YOY. The Group’s global operation capability was further enhanced, and revenue from regions and countries outside Chinese mainland reached RMB7,592 million, accounting for 35.58% of the total revenue and a YOY increase of 4.92 percentage points.

"In the first half of 2022, despite the pressure arising from Covid-19 resurgence in various regions of China, Fosun Pharma continued to promote innovation and transformation, comprehensively accelerated its international layout, strengthened the product pipelines, promoted the integration of operation, improved the efficiency in business divisions, and achieved solid growth." said Wu Yifang, Chairman of Fosun Pharma. "Fosun Pharma’s core competitiveness is embodied in its open R&D ecology, forward-looking international layout, and systematic commercialization team. In the second half of 2022, Fosun Pharma will continue implementing the 4IN strategy, increasing R&D investment, continuously optimizing operational control, improving asset operational efficiency, and actively expanding cooperation opportunities with leading global pharmaceutical companies. With patient-centered and clinical needs-oriented, the Group will continue to innovate and promote more good products into the global market, and bring health to all families."

Continuously Promoting Innovation & Transformation, Revenue Contribution of New Products and Sub-New Products Reached over 25%

Fosun Pharma’s innovative R&D is always based on satisfying unmet clinical needs, adhering to technology-driven and product-driven, and accessing global outstanding scientific talents, leading technologies and high-value products through diversified and multi-level cooperation modes such as independent R&D, co-development, license-in projects and deep incubation. By the end of June 2022, Fosun Pharma has over 2,800 R&D personnel, of which over 1,500 have master’s degrees or above. More than 260 pipeline projects, including innovative drugs, biosimilars, generic drugs and consistency evaluation items are under research.

Fosun Pharma continues to increase its investment in R&D. In the first half of 2022, R&D expenditures reached RMB 2,399 million, an increase of 22.77 % YOY. Among them, R&D expenses reached RMB 1,818 million, representing a period-on-period increase of RMB256 million or 16.39%. The R&D expenditures in the pharmaceutical manufacturing segment reached RMB 2,062 million, representing a period-on-period increase of 16.04%. Total R&D expenditures in the pharmaceutical manufacturing segment accounted for 14.39% of the revenue from the pharmaceutical manufacturing segment. In particular, R&D expenses amounted to RMB 1,491 million, accounting for 10.41% of the revenue from the pharmaceutical manufacturing segment.

Product structure optimization and sales growth from new product launches were the key drivers of Fosun Pharma’s results. In the first half of 2022, the revenue of new products and sub-new products, including COMIRNATY (in Hong Kong, Macau, and Taiwan region), Han Li Kang, Han Qu You, Su Ke Xin and Han Si Zhuang accounted for more than 25% of the revenue from the pharmaceutical manufacturing segment.

Yi Kai Da (Axicabtagene Ciloleucel Injection) of Fosun Kite, a joint venture, as the first CAR-T cell therapy product approved for launch in China, has been launched for more than one year. As of the end of July 2022, Yi Kai Da has been included in the urban customized commercial health insurance of 44 provinces and municipalities and over 50 commercial insurances, while the number of treatment centers on file had reached nearly 100.

Deepening Global Operation and Becoming a Preferred Domestic World-renowned Partner of Multinational Pharmaceutical Companies

Fosun Pharma continuously strengthened its global operation capability, and implemented a multi-dimensional internationalization strategy in innovation and research, license-in, production and operation, as well as commercialization. Significant progress has been made in its market access capability by establishing commercialization team building in the United States, Africa, Hong Kong and Macau markets. By the end of June 2022, the overseas commercial team of Fosun Pharma comprised more than 1,400 employees. Fosun Pharma has established marketing platforms in the United States, Africa and Europe, and achieved the direct sales of preparations to the United States market. Sisram Medical, Breas and other medical device business have covered major regions such as China, the United States and Europe, and Fosun Diagnosis’ COVID-19 nucleic acid test kits and COVID-19 antigen test kits have been sold in more than ten countries.

Relying on years of domestic industry experience and global channel network, Fosun Pharma has become the preferred domestic partner of world-renowned multinational pharmaceutical companies.

In the first half of 2022, Fosun Pharma and Amgen’s subsidiary entered into a licensing agreement regarding the exclusive commercialization of its 2 innovative drugs, namely Otezla (apemilast tablets) and Parsabiv (etelcalcetide), in Chinese Mainland (excluding Hong Kong, Macau and Taiwan region) to further enrich the Group’s innovative product layout in the non-oncology field.

Fosun Pharma’s industry-leading License-In & Out capabilities maximize the value of independently developed products and innovative products of partners. In the first half of 2022, Shanghai Henlius, a subsidiary, has successively granted various product licenses to Organon, Eurofarma, Getz Pharma and other companies, in order to cover incremental markets with the help of leading international partners.

Relying on the Fosun Pharma’s international production standards and quality system certifications, together with overseas product access and marketing capabilities, in January and March 2022, Fosun Pharma’s subsidiary Fosun Pharmaceutical Industrial was licensed to manufacture and supply the generic versions of Molnupiravir, a COVID-19 oral drug of Merck, and Nirmatrelvir, a COVID-19 oral drug of Pfizer, and a combination of Nirmatrelvir/Ritonavir by MPP for certain mid- and low-income countries in the world. The license allows the production of the active pharmaceutical ingredient and the finished drug, continuing to contribute to the global efforts to fight COVID-19.

In order to further improve the cost competitiveness of products and to enhance the rational allocation of production resources, Fosun Pharma is actively integrating manufacturing capacities to build a large-scale, cost-competitive manufacturing system. In China, Fosun Pharma is building two comprehensive pharmaceutical preparation manufacturing centers and three raw pharmaceutical production bases to consolidate the strength in the integrated production of APIs gradually. Overseas, several injectables manufacturing lines of Gland Pharma have passed GMP certification in the US, EU, Japan, Australia and other major regulatory markets, supplying the global market.

Fighting Against Epidemic Together to Secure Production and Actively Fulfilling Corporate Social Responsibility

In the first half of 2022, the domestic epidemic spread in various provinces and cities, and the production, supply chain, logistics as well as the number of hospital offline diagnosis and treatment faced staged pressure. Fosun Pharma responded to the local pandemic prevention and control policies and actively took countermeasures to ensure production and operation activities were conducted orderly. Fosun Pharma secured the production and supply of key drugs such as Han Qu You, Han Li Kang and Yi Kai Da as well as anti-epidemic materials such as nucleic acid test kits and antigen test kits for COVID-19 during the pandemic through centralized closed-loop management of front-line production personnel, increased supply chain and logistics options and other means, comprehensively assisting the prevention and control of the pandemic by focusing on prevention, detection and treatment of COVID-19.

The Group continued to ensure the supply of Comirnaty (mRNA COVID-19 vaccine) to Hong Kong, Macau and Taiwan region, to meet the local needs for epidemic prevention and control. In July 2022, Fosun Pharmaceutical Industrial, a subsidiary of Fosun Pharma, and Genuine Biotech entered into an agreement in relation to the strategic cooperation on, among other things, the joint development and Fosun Pharmaceutical Industrial’s exclusive commercialization of Azvudine. The cooperation scope includes the treatment and prevention of Novel Coronavirus (2019- nCoV) and AIDS. The Azvudine tablets, independently developed by China, is the first small molecular oral medication for COVID-19 approved for launch. On 25 July 2022, the drug obtained the emergency conditional approval from the NMPA for use in treatment of adult patients suffering moderate COVID-19.

Since August 2022, there have been epidemic resurgences in Hainan and Henan provinces, Xinjiang and Tibet autonomous regions, and other regions in China. Prevention and control situation of COVID-19 remain severe and complex. Fosun Pharma and Genuine Biotech actively responded to the needs of local governments and deployed Azvudine tablets to many places across the country urgently and helped build a solid barrier for epidemic prevention and control, to protect people’s health.

With remarkable achievements in environmental, social, and corporate governance (ESG) and positive contributions in the fight against the COVID-19 pandemic, Fosun Pharma topped the 2022 Fortune China ESG Impact List.

NCCN Announces Collaboration with Myovant Sciences and Pfizer to Support Projects to Understand and Mitigate Cardiovascular Risk in Patients with Prostate Cancer

On August 30, 2022 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported a collaboration with Pfizer and Myovant Sciences to fund research projects seeking to improve cardiovascular management of patients with prostate cancer being treated with androgen-deprivation therapy (ADT) (Press release, NCCN, AUG 30, 2022, View Source [SID1234618792]).

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"Cardiovascular disease is an important comorbid condition in many patients living with prostate cancer, especially in those receiving ADT," said Crystal S. Denlinger, MD, FACP, Senior Vice President, Chief Scientific Officer, NCCN. "Congratulations to all of these inspiring investigators. We hope their work can advance the management of cardiovascular risk to improve overall health of this patient population."

The selected research projects are:

Zhaoping Li, MD, PhD, David Geffen School of Medicine at UCLA

Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy

Alicia Morgans, MD, MPH, Dana-Farber Cancer Institute

CV CARE: Cardiovascular Care of Androgen Related Effects in Prostate Cancer Patients

Vivek Narayan, MD, MSCE, University of Pennsylvania, Abramson Cancer Center

The Cardiovascular Risk Evaluation in Men with Prostate Cancer (CARE-PC): Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation

Camille Ragin, PhD, MPH, and Daniel Geynisman, MD, Fox Chase Cancer Center

Investigating the Role of African Genetic Ancestry in Cardiovascular Complications and Cardiotoxicity among Prostate Cancer Patients Post Treatment with Androgen Deprivation Therapy

Balaji Tamarappoo, MD, PhD, Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment with Quantitative Coronary CT Angiography
Roughly half of the people treated for prostate cancer receive ADT, often for a prolonged duration. A majority of them may have pre-existing risk factors for cardiovascular disease, which is the primary cause of non-cancer death among people with prostate cancer. Data also shows that roughly a third of patients with uncontrolled risk factors for cardiovascular events are not on appropriate medications. The goal of this project is to improve the awareness, identification, and implementation of interventions for known modifiable risk factors (i.e. hypertension, dyslipidemia, diabetes) for cardiovascular disease.

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert clinicians and scientists from NCCN Member Institutions. The selected projects are set to be completed within three years. The total amount of grants awarded for this research is approximately $1.5 million.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website, an informed consent database, and points to consider on the best practices for biorepositories, registries, and databases. For more information, visit NCCN.org/orp.

IDEAYA Biosciences to Participate in Investor Conferences in September 2022

On August 30, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in investor conferences and events in September 2022 (Press release, Ideaya Biosciences, AUG 30, 2022, View Source [SID1234618791]).

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Citi’s 17th Annual BioPharma Conference
September 7-8, 2022

Wells Fargo Healthcare Conference
September 7-9, 2022

Morgan Stanley 20th Annual Global Healthcare Conference
September 12-14, 2022
Monday, September 12 at 4:15pm ET
Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by Ashwin Pai, M.D. Managing Director

Baird 20th 2022 Global Healthcare Conference
September 13-14, 2022
Wednesday, September 14 at 9:05am ET
Corporate Presentation by Paul Stone, Chief Financial Officer, IDEAYA Biosciences

Oppenheimer’s Oncology Summit / University of Texas MD Anderson Cancer Center
September 21, 2022

Cantor Oncology, Hematology & HemOnc Conference
September 28, 2022
Wednesday, September 28
Panel: "Novel Targets in Oncology: Risk vs. Reward", with participation by Mike White, Chief Scientific Officer, IDEAYA Biosciences

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

Antengene Announces Interim 2022 Financial Results and Provides Corporate Update

On August 30, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported its interim results for the six months ended June 30, 2022, and provided corporate updates on key events and achievements since the start of 2022 (Press release, Antengene, AUG 30, 2022, View Source [SID1234618790]).

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"As we celebrate the fifth anniversary of Antengene’s founding, we are delivering on our long-term vision to build a global, multi-product biopharmaceutical company that is successfully developing novel and commercializing ground-breaking products in oncology/hematology. I am pleased to report that we delivered excellent 2022 interim results across the three main components of our long-term success, in our commercial product, clinical pipeline, and discovery," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "So far this year, we successfully launched our lead first-in-class/only-in-class product, XPOVIO, in Mainland China and reported product revenue of RMB 53.96 million. The strong sales momentum highlights Antengene’s transformation into a commercial organization and demonstrates our team’s robust commercialization capabilities in China and the APAC markets. In addition, we progressed three first-in-human programs, and plan to advance one to two more this year. Furthermore, we have entered into two collaborations to evaluate new treatment combinations and innovative new technologies."

Dr. Mei continued, "Looking ahead, we are increasingly enthusiastic about XPOVIO and believe it is an enabler for Antengene’s future growth. Since July 2021, the product has been approved in 4 markets, incorporated in practice guidelines by 5 leading international medical societies, and is currently being studied in 8 trials to substantially broaden the use to encompass earlier lines of therapy, new treatment regimens, and additional hematology, and potentially solid tumor indications."

Dr. Mei commented further, "Turning to our clinical pipeline of differentiated, first-in-class/best-in-class programs, before the end of the year, we intend to report critical clinical data on two mid-stage programs – ATG-016 (eltanexor), a next generation XPO1 inhibitor and ATG-008 (onatasertib), an mTORC1/2 inhibitor, and one Phase I dose escalation program for our ERK1/2 inhibitor, and file one additional IND for an antibody drug conjugate to Claudin 18.2 and completing preparations for an IND filing for the exciting ‘don’t eat me signal’ blocker, anti-CD24 antibody. Our team of over 400 employees across China, APAC regions, and the US, plus our core capabilities in discovery, development, and manufacturing, support our deep and productive early-stage research that is poised to deliver a steady flow of opportunities based on a broad range of novel targets, modalities, innovative technologies, and partnerships."

In conclusion, Dr. Mei said "Looking forward, we believe our cash and bank balances of RMB 2.151 billion, strong near-term revenue growth potential and careful budgetary control will enable overall company growth and development, and support our operations. Cancer is a disease that knows no borders, so we are driven to develop advanced cancer therapies and innovative medicines with differentiated profiles for the benefit of broad patient populations globally and to deliver value for our investors. Antengene is optimistic about this year and the future based on the dedication of our team, and collaborators all around the world. We look forward to updating you on our progress throughout the rest of this year and in the future."

Interim Financial Results and Highlights

For the interim period ended June 30, 2022, Antengene reported results, compared to the interim period ended June 30, 2021:

Revenues of RMB 53.96 million, mainly attributable to the commercial launch of XPOVIO in Mainland China on May 13, 2022 compared to nil for the comparable period in 2021
Adjusted loss of RMB 126 million, compared to RMB 210 million for the comparable period in 2021.
Cash, bank balances and cash management products were RMB 2.151 billion as of June 30, 2022 compared to RMB 2.370 billion as on December 31, 2021.
XPOVIO Key Performance Indicators in APAC markets as of June 30, 2022

Approved in 4 markets: Mainland China, South Korea, Singapore, and Australia for hematologic cancer indications, including in combinations with existing regimens for the treatment of relapsed/refractory multiple myeloma (R/R MM as part of established multi-drug regimens) and as a monotherapy for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
Broad acceptance by major clinical guidelines: 6 regimens have received 18 recommendations by the clinical guidelines of 5 leading medical societies, including the National Comprehensive Cancer Network (NCCN) Guidelines, the Chinese Society of Clinical Oncology (CSCO) Guidelines, the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Guidelines, the International Myeloma Working Group (IMWG) Guidelines and the Guidelines for the Treatment and Diagnosis of Multiple Myeloma in China.
8 clinical studies of XPOVIO are underway, including 4 registrational studies, 2 of which are global studies jointly conducted by Antengene and Karyopharm Therapeutics Inc.
MARCH results were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and published in BMC Medicine.
Well-prepared commercial team of nearly 190 personnel with a proven track record of commercial success in China and APAC has paved the way to a successful launch of XPOVIO. In addition, we have developed a deep understanding of the dynamics and key stakeholders in our target markets, including KOLs, physicians, and leading industry organizations.
Mid to Late-Stage Programs (Antengene has certain Asia-Pacific rights)

Antengene is exploring two members of the novel XPO1 inhibitors plus a novel mTORC 1/2 dual inhibitor.

– Selinexor (ATG-010, first-in-class XPO1 inhibitor): We are highly committed to the further development of XPOVIO, with an extensive program in MM and non-Hodgkin lymphoma (NHL), including a number of combination developments, that can help expand our label and market. The drug is being tested as a monotherapy or as an add-on to standard therapy in MM, DLBCL, as well as other hematologic malignancies. These programs aim to potentially improve response rates and expand the clinical utility of the drug.

In May 2022, the Phase I/II SWATCH trial was designed to evaluate selinexor in combination with lenalidomide plus rituximab (SR2) for the treatment of R/R DLBCL and relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) dosed its first patient in China.
Data from the pivotal MARCH study in patients with R/R MM were presented at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, and published in BMC Medicine.
– Eltanexor (ATG-016, second generation XPO1 inhibitor)

Phase II segment of the KCP-8602 trial in solid tumors/hematologic malignancies is currently enrolling patients with high-risk myelodysplastic syndromes (MDS) in China.
– Onatasertib (ATG-008, mTORC1/2 inhibitor)

Results from the Phase I/II TORCH-2 study of ATG-008 plus toripalimab in solid tumors were announced at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Early-Stage Clinical Programs (Antengene has global rights)

Antengene’s early-stage clinical programs have differentiated features that could provide distinct competitive advantages to other products in the areas

ATG-017 (ERK1/2 inhibitor) has potential synergy with checkpoint inhibitors and KRAS inhibitors. The Phase I ERASER study in patients with advanced solid tumors and hematologic malignancies is underway in Australia. Antengene is collaborating clinically with Bristol Myers Squibb to evaluate ATG-017 in combination with Opdivo (nivolumab) in patients with advanced solid tumors.
ATG-101 (PD-L1/4-1BB bispecific antibody) was designed to block the binding of immunosuppressive PD-1/PD-L1 and activate immune effectors. The multicenter Phase I PROBE study in patients metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) is ongoing in the US, Australia, and China.
ATG-037 (CD73 small molecule inhibitor) reduces immunosuppression in the tumor microenvironment. Enrollment in the Phase I STAMINA trial of ATG-037 in patients with locally advanced or metastatic solid tumors is underway in Australia.
ATG-018 (ATR small molecule inhibitor) limits DNA damage repair mechanisms in tumor cells. The Phase I ATRIUM Study for the patients with advanced solid tumors and hematologic malignancies dosed its first patient in Australia.
Internal Discovery Program

IND Candidates for the Remainder of 2022: ATG-022 (Claudin 18.2 antibody-drug conjugate). IND filing expected in 2H2022.
2023 Potential IND/CTA Filings: ATG-031 (anti-CD24 monoclonal antibody).
Early Stage, IND Track Programs: ATG-027 (B7H3/PD-L1 bispecific antibody), ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)
Business Development

Antengene’s business development strategy is focused on partnerships to facilitate clinical collaborations, in-license novel programs, or enable access to novel platform/drug development technologies to complement and enrich our in-house capabilities.

Entered into a clinical collaboration with BeiGene, Ltd. to evaluate XPOVIO in combination with tislelizumab in a Phase I/II trial in patients with T and NK Cell lymphoma.
Entered into a research collaboration with Celularity Inc. to evaluate the potential therapeutic synergy from combining one of Antengene’s novel bispecific antibodies with Celularity’s cryopreserved human placental hematopoietic stem cell-derived NK cell therapy platform.
Clinical Programs Poised to Deliver Proof-of-Concept Data in 2022 and 2023 (originated in-house/through partners): The Antengene pipeline has been developed with a particular interest in addressing those mechanisms that underly resistant diseases, and how we can reverse those resistance mechanisms, or modulate the tumor microenvironment in a way that allows the regaining of control of cancer growth. This portfolio is extremely well positioned to allow us to evaluate proprietary combinations, from our pipeline.
Corporate Updates

Biologics Drug Discovery Laboratory in Hangzhou Qiantang New Area: The construction of the 2,600 m2 biologics drug discovery laboratory in Hangzhou was completed and became fully operational in May 2022. This laboratory focuses on new antibody discovery. Currently, there are 16 scientists on-board.
Biologics Manufacturing Facility in Hangzhou Qiantang New Area: The ground-breaking ceremony for the biologics manufacturing facility in Hangzhou was held in August 2022. This would be a staged construction project spreading over three years, from 2022 to 2025.
Financial Results

Cash, bank balances and cash management products: Cash, bank balances and cash management products on June 30, 2022 were RMB 2.151 billion as compared to RMB 2.370 billion on December 31, 2021.

Revenue: Revenue for the period ended June 30, 2022 was RMB 53.96 million as compared to nil for the comparable period in 2021.

The increase in revenue is primarily attributable to the commercial launch of XPOVIO, a first-in-class XPO-1 inhibitor, in Mainland China on May 13, 2022.

Research and development costs: Research and development costs for the period ended June 30, 2022 were RMB 179 million as compared to RMB 135 million for the comparable period in 2021.

The increase is primarily attributable to increased drug development expenses and expansion of R&D personnel.

Selling and distribution expense: Selling and distribution expenses for the period ended June 30, 2022 were RMB 90.4 million compared to RMB 0.1 million for the comparable period in 2021.

The increase is primarily attributable to increased employee costs and market development expenses to launch our lead product, XPOVIO.

Administrative expenses: Administrative expenses for the period ended June 30, 2022 were RMB 85.9 million compared to RMB 78.5 million for the comparable period in 2021.

The increase is primarily attributable to increased professional fees in relation to operating and administrative activities.

Adjusted loss: Adjusted loss for the period ended June 30, 2022 was RMB 126 million compared to RMB 210 million for the comparable period in 2021.

Outlook for 2022 and Beyond: Business and Pipeline Objectives

2 Additional NDA approvals of XPOVIO expected: Hong Kong and Taiwan
PBS listing (Australia Reimbursement) of XPOVIO in Australia expected by the end of 2022 (Australia Reimbursement)
Obtaining the complete data set for expansion cohorts of the Phase II TORCH-2 study: ATG-008 in combination with toripalimab
Interim data read-out for Phase II study: ATG-016 in patients with MDS
Preliminary data read-out in first-in-human studies of the ERASER study of ATG-017
Near-term IND filings: ATG-022 (Claudin 18.2 ADC), ATG-031 (anti-CD24 monoclonal antibody)