On August 25, 2023 Henlius (2696.HK) reported its 2023 interim results (Press release, Henlius Biopharmaceuticals, AUG 25, 2023, View Source [SID1234634701]). In the first half of 2023, Henlius reported a boost in operating profits of RMB240.0 million and revenues of RMB2.5005 billion, up by 93.9% YoY, driven by growth in core oncology products. HANQUYOU (trastuzumab) and HANSIZHUANG (anti-PD-1 mAb) recorded sales of RMB1.2767 billion and RMB556.3 million, respectively.

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As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 5 self-developed products have been launched, reaching more than 40 markets and benefiting over 450,000 patients. Over 10 marketing applications have been accepted for review in China, the United States (U.S.), the European Union (EU), Brazil, Canada, Indonesia, Singapore and other countries and regions. While accelerating global expansion, Henlius continues to invest in innovation with total spending on R&D hitting RMB673.8 million in the first half of 2023.

Wenjie Zhang, Chairman and Executive Director of Henlius, remarked: "During the first half of 2023, Henlius achieved a rather remarkable milestone, becoming profitable for the first time in half a year. In particular, HANQUYOU and HANSIZHUANG have led to a jump in total revenue. As we progressed toward self-financing and increased momentum, we optimized our internal operations, refined our systems, and deepened our moats, thus laying the groundwork for long-term sustainable and high-quality growth to keep up in the global race."

Jason Zhu, Chief Executive Officer, President and Chief Financial Officer, said: "Innovation and collaboration have allowed us to penetrate markets and expand with momentum. Moreover, lean operations have enabled us to unleash new growth opportunities and reach beyond our own borders. As we progress, we will maintain an innovative outlook and work closely with our partners to benefit patients worldwide."

Global sales on an unstoppable growth streak

In the first half of 2023, Henlius achieved a total sales revenue at a record high of approximately RMB2.1529 billion increased by 82.2% YoY, with its ever-increasing self-supporting capability, driving the company into a new stage of sustainable development. The company has established a professional and efficient commercial team to build a business presence in the China market and drive the market penetration on the in-house products HANQUYOU, HANSIZHUANG and HANBEITAI (bevacizumab). In the first half of 2023, these core products of the company gained sales revenue of RMB1.2767 billion, RMB556.3 million and RMB44.9 million, respectively. In addition, the company received a profit-sharing of RMB254.1 million and RMB20.8 million for HANLIKANG (rituximab) and HANDAYUAN (adalimumab) respectively.

Henlius’ core oncology product, HANQUYOU (trastuzumab, trade name in Europe: Zercepac, trade name in Australia: Tuzucip and Trastucip), continues to grow at a rapid pace and achieved global sales of approximately RMB1.2767 billion in the first half of 2023, up by 57.1% YoY. Specifically, its market share has been further expanded in China. Since March 2023, the monthly sales in Chinese mainland have exceeded RMB200 million. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB1.2471 billion, representing an increase of 55.8% YoY. Overseas revenue from product sales and licensing recorded RMB32.8 million approximately, up by 120.1% YoY. Henlius has been actively promoting the global commercialization of HANQUYOU, resulting in its approval in more than 40 countries, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia, which makes it the China-developed biosimilar with the most marketing approvals. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA) and is expected to approve in the second half of the year and to further cover mainstream biopharmaceutical markets and benefit more patients around the world.

HANSIZHUANG (serplulimab), the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC), has achieved total sales revenue of RMB556.3 million in the first half of 2023. Its monthly sales in Chinese mainland have exceeded RMB100 million since March 2023, a year after its launch. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). Up to date, HANSIZHUANG has completed the tendering process in 29 provinces, and was included into customized commercial medical insurance in 17 cities and provinces, benefitting over 34,000 patients. On the other hand, the New Drug Applications (NDAs) for HANSIZHUANG in the first-line treatment of esophageal squamous cell carcinoma (ESCC) has been accepted by the NMPA in China, with a decision expected in the second half of 2023. If approved, ESCC will be the fourth disease indication for HANSIZHUANG. The company also plans to submit NDA for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the second half of 2023. Furthermore, the company is advancing the commercialization of HANSIZHUANG on overseas markets at high speed. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG and is expected to be approved in the first half of 2024. The company also plans to submit BLA to the U.S. FDA in 2024.

In the first half of 2023, the company continued to strengthen, broaden, and deepen its business development around the world, generating approximately RMB347.57 million in overseas licensing and other revenue, an increase of 222.5% YoY. The company joined hands with international partners such as Accord, Abbott, Boston Oncology, Getz Pharma, Elea, Eurofarma, KGbio and Fosun Pharma to accelerate overseas commercialization of products such as HANQUYOU, HANSIZHUNAG, HANLIKANG, HANDAYUAN, and HANBEITAI in countries and regions including the U.S., the EU, Brazil, Canada, Singapore, and Indonesia. In addition, the company is committed to improving the accessibility of immunotherapies and medicines for autoimmune diseases in emerging markets. During the reporting period, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. For the commercialization of HANSIZHUANG, the company expanded its collaboration with KGbio to include 12 MENA countries in addition to the previously agreed 10 ASEAN countries.

R&D innovation underpinned future

The first half of 2023 saw Henlius continue its differentiated innovation and R&D initiatives, exploring novel targets and molecular mechanisms in more disease areas. As the company continues to deploy its innovation centres in California and Shanghai to optimize its research layout, it also steadily expands its clinical layout worldwide. Currently, Henlius has pro-actively built a diversified and high-quality product pipeline, including over 60 molecules across monoclonal antibody (mAb), bispecific antibody (BsAb), ADC, fusion protein, and small molecule drug conjugate, of which more than 80% are self-developed. During the reporting period, Henlius is conducting over 30 clinical studies for more than 10 products globally, including 8 phase 3 clinical trials. In addition, 1 product has been granted a Breakthrough Therapy Designation (BTD) by the NMPA, 6 clinical trials have made important progress, and the Investigational New Drug Applications (INDs) for 2 potential first-in-class ADC candidates were accepted for review by the NMPA.

Henlius has actively expanded its differentiated advantages for HANSIZHUANG and has launched over 10 clinical trials of combination therapy worldwide with over 3,600 subjects enrolled globally. In addition to the launched indications of sqNSCLC and ES-SCLC, Henlius also explored to treat patients with nsNSCLC and limited-stage small cell lung cancer (LS-SCLC), covering the full range of first-line treatments of lung cancers. Over 90% of lung cancer patients are expected to benefit from the therapies. Among them, the first patients in the U.S. and Australia have been dosed in an international multi-centre phase 3 clinical trial of HANSIZHUANG in LS-SCLC in January and April 2023, respectively. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. As of now, 38 trial sites have been initiated, which is expected to accelerate the progress of the trial thus propelling the product towards US market approval. In the area of gastrointestinal cancer, the results of HANSIZHUANG for the first-line treatment of ESCC was published in Nature Medicine (IF: 82.9) and also updated at 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy.

In the first half of 2023, the company continues to make every effort to promote the global multicentre phase 3 clinical studies for HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb). The first patient in the U.S. was dosed in phase 3 clinical trials of HLX04-O for wAMD in the first half of 2023. Moreover, the latest clinical results for HLX208 (BRAF V600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb) and HLX26 (anti-LAG-3 mAb) were presented to global academic community. Several potential first-in-class candidates are being fully promoted from discovery to early-stage clinical pipeline. During the reporting period, the phase 1 clinical trial for the company’s self-developed HLX51, a novel humanized agonistic anti-OX40 mAb for the treatment of patients with advanced/metastatic solid tumours and lymphomas has been approved by the NMPA. Moreover, the company further strengthened its commitment in innovation and enhanced its Linker-Centric Diversified Conjugate Platforms. Utilizing the self-developed ADC platform Hanjugator, Henlius is actively pursuing clinical trial approval for HLX42 (a novel EGFR-targeting ADC) and HLX43 (a novel PD-L1-targeting ADC).

Elevating quality and efficiency, steadfastly pursuing global supply

Henlius has been building an integrated and comprehensive production platform to continuously improve the accessibility of its products. The current commercial production capacity is 48,000 litres, and Songjiang First Plant and Xuhui Facility have been officially put into operation, forming synergy, and developing scale effects that allow the company to supply products stably to markets beyond China, including Europe and Latin America. To further meet the global commercial production needs, the company is constructing Songjiang Second Plant, with a total capacity of 96,000 litres in the first phase. In 2026, the total production capacity is expected to reach 144,000 litres. In the first half year of 2023, Henlius made progress in lean operations and the localization of key materials and continued to evolve supply chain sustainability. The company adopted such cutting-edge technologies as Raman Spectroscopy and such system as manufacturing SCADA system.

The company has always been upholding the highest quality standards, allowing its products to go global. Xuhui Facility has been certificated by China and the EU GMP while Songjiang First Plant obtained China GMP and the EU Qualified Person (QP) certification. The company’s commercial production facilities and supporting quality management system have also passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. In July and August 2023, Xuhui Facility received the GMP inspection conducted by PIC/S member the Indonesian Food and Drug Authority ("BPOM") for the production line of HANSIZHUANG and Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU, respectively.

Henlius has always been patient-centred and committed to addressing more unmet clinical needs. The company will continue to improve the efficiency of our business operations and innovation, strengthen partnerships with international partners, and expand its global presence in the future.

On August 25, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), reported its interim results for the six-months ended June 30, 2023, and provided updates on multiple milestones achieved since the beginning of 2023 (Press release, Antengene, AUG 25, 2023, View Source [SID1234634700]).

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Dr. Jay Mei, Antengene’s Founder, Chairman and CEO, said, "In the first half of this year, Antengene has achieved significant progress across its clinical programs. We are very encouraged that the mTORC1/2 inhibitor ATG-008, a drug candidate in late-stage clinical development, continues to show impressive and robust therapeutic potential in patients with cervical cancer with expanded patient enrollment. Meanwhile, we have made big strides with our global rights assets, particularly ATG-022 (Claudin 18.2 antibody-drug conjugate) and ATG-101 (PD-L1/4-1BB bispecific antibody), two clinical stage global rights programs in dose escalation studies that have already reported partial responses (PRs) at clinical centers at low dose levels. Furthermore, ATG-031, one of our in-house developed programs, has been cleared by the US FDA to enter a clinical study, thus becoming the world’s first CD24 monoclonal antibody entering clinical development in oncology. We look forward to releasing more clinical data as we progress into the next few months. While making rapid advances in clinical development, we entered into a landmark partnership with Hansoh Pharma, one of the largest pharmaceutical companies in China. We are confident that this partnership will further expand the commercial reach of XPOVIO in China and boost the opportunities for the drug upon additional NRDL listings and indication expansions. During the same period, we delivered on multiple commercial milestones for XPOVIO in our APAC markets, namely the recent regulatory approval for the drug in Hong Kong China, NDA submission in Indonesia, expanded insurance coverage by the Australian Pharmaceutical Benefits Scheme (PBS) for the two XPOVIO regimens, and inclusion into the Cancer Drug List in Singapore." Dr. Mei continued, "With the rapid progress in our differentiated clinical portfolio, positive early results from multiple trials, momentous growth trajectory for XPOVIO, and a solid cash position, we are well positioned to maintain steady progress in our global R&D pipeline and deliver on our mission of bringing more transformative medicines to cancer patients around the world."

1. Excellent progress in first/best-in-class global rights clinical programs with clinical readouts beginning this fall

Antengene has built an expansive pipeline of oncology drugs at various stages going from clinical to commercial. This pipeline comprises 6 global rights assets and 3 assets with rights for the APAC region.

ATG-022 (Claudin 18.2 antibody-drug conjugate), with activity across a range of Claudin 18.2 expression levels, advanced to Phase I in Australia and the Mainland of China, and granted two Orphan Drug Designations (ODD) consecutively by the U.S. Food and Drug Administration (FDA) for treatment of gastric and pancreatic cancers. The drug is currently enrolling patients in the dose escalation phase, and a PR has already been reported by the clinical center earlier than the projected efficacious dose range.
ATG-031 (anti-CD24 monoclonal antibody), a potential first-in-class program to target the "don’t eat me" pathways, has successfully achieved US IND clearance for its Phase I trial. Our preclinical data suggest that CD24 is a target not expressed on human red blood cells, meaning that it will unlikely cause anemia issues commonly seen in molecules targeting CD47. Moreover, CD24 has higher tumor expression compared to CD47, making it a differentiated, high-potential approach to this exciting macrophage-regulating pathway. Antengene has selected multiple centers across the US for this clinical trial, with the MD Anderson Cancer Center in Houston, TX as the leading clinical site which is currently in active preparation for initiation. As part of the site initiation process, the Scientific Review Committee of MD Anderson Cancer Center has granted approval, putting us on a solid track to initiate enrollment in the fourth quarter of this year.
ATG-101 (PD-L1/4-1BB bispecific antibody) has been designed to target PD-1/PD-L1 resistant cancers, supported by conditional 4-1BB activation of an enhanced T-cell response. The program is currently in dose escalation cohorts in its study spanning the Mainland of China, Australia, and the United States. The study is approaching the biologically active dose with good tolerability, and has already reported PR and durable stable diseases (SDs) in patients treated at low doses levels. Notably, from low dose level, SD has been observed in the longest-treated patient who had been on the drug for over a year.
ATG-037 (CD73 inhibitor), which shows preclinical activity in the CD73 pathway without a hook effect, is advancing through a dose escalation study. Patients are being enrolled at both Australian and Chinese sites. The trial was designed to include a dose escalation study of ATG-037 monotherapy and in combination with pembrolizumab, to assess the potential for additional clinical benefits. At present, a total of 13 patients have started the combination treatment.
ATG-017 (ERK1/2 inhibitor), a small molecular kinase inhibitor, has reached RP2D for monotherapy and successfully progressed to a combination dose expansion study, in conjunction with nivolumab, in the US and Australia.
ATG-018 (ATR inhibitor), a unique small molecule inhibitor, is making smooth progress through its dose escalation phase. 7 patients are with stable disease out of 12 efficacy evaluable patients at low dose levels.
AACR posters highlighted preclinical proof-of-concept data for three clinical programs: ATG-031 (anti-CD24 monoclonal antibody), ATG-017 (ERK1/2 inhibitor), ATG-037 (CD73 inhibitor) and a new research program: an LILRB4 antagonist antibody, ATG-034.
2. Encouraging clinical results for mid-to-late-stage APAC programs

ATG-008 (mTORC1/2 inhibitor) unique, differentiated results in cervical cancer – The Phase II "TORCH-2" study is currently enrolling both checkpoint inhibitor (CPI)-naïve and CPI-pre-treated cervical cancer patients. Based on the latest data review as of August 23rd, 2023, out of the 31 CPI-naïve patients who received treatment (and 28 who had at least one tumor assessment), the objective response rate (ORR) was observed to be 46.4%. Among the 17 patients with prior CPI treatment (and 15 patients who had at least one tumor assessment), the ORR was observed to be 26.7%. Updated clinical data will be presented in the Antengene Annual R&D Day in November.
Selinexor (XPO1 inhibitor) expansion opportunities in Myelofibrosis and endometrial cancer – These clinical data demonstrate the deep and broad expansion potential of selinexor beyond the initial indications of multiple myeloma and diffuse large B-cell lymphoma.
Myelofibrosis: Results from the "XPORT-MF-034" study evaluating selinexor in combination with ruxolitinib in treating treatment-naïve myelofibrosis patients show that 91.7% of efficacy evaluable patients and78.6% of intent-to-treat (ITT) patients achieved a 35% or greater spleen volume reduction (SVR35) at week 24. Moreover, 77.8% of efficacy evaluable patients and 58.3% ITT patients achieved a 50% or greater reduction of their total symptom score (TSS50) at week 24. As a co-sponsor of the global registrational Phase III trial, Antengene will participate in the planning and conduction of the trial in the Mainland of China.
Endometrial Cancer: Updated exploratory subgroup analyses from the Phase III "SIENDO" study of selinexor as a maintenance therapy in patients with advanced or recurrent endometrial cancer showed a median progression free survival (PFS) of 27.4 months among TP53 wild-type endometrial cancer patients who were treated with selinexor as a maintenance therapy, compared to 5.2 months in the placebo cohort. Karyopharm is currently conducting the "XPORT-EC-042" study, a registrational Phase III trial in the US for indication expansion into the maintenance setting for endometrial cancer. Topline data are expected in late 2024-2025. A U.S. approval could open the door to registration in Antengene’s territories.
3. Fast-Growing Pan-APAC commercialization of XPOVIO spotlighting the new partnership with Chinese pharmaceutical company Hansoh Pharma for the commercialization of XPOVIO in the Mainland of China

In the first six months of 2023, XPOVIO obtained a New Drug Application (NDA) approval in Hong Kong China, achieved expansion in the insurance coverage by the Australian Pharmaceutical Benefits Scheme (PBS) to the XVd regimen, beyond the initially included Xd regimen, and was included into the Cancer Drug List in Singapore. Moreover, Antengene has completed an NDA submission for XPOVIO in Indonesia. Antengene plans to submit a supplementary NDA (sNDA) for XPOVIO for the treatment of relapsed/refractory diffuse large B-cell lymphoma in China in 2H 2023.
The exclusive partnership with Hansoh Pharma for the commercialization of XPOVIO in the Mainland of China positions Antengene to achieve greater national coverage across a larger number of cities, hospitals, prescribers, and maximizes the opportunity for future National Reimbursement Drug List (NRDL) inclusions.
Deal terms include upfront payment of up to RMB200 million and future milestone payments of up to RMB535 million. Antengene will continue to record revenues from sales of XPOVIO in the Mainland of China and Hansoh Pharma will charge a service fee to Antengene.
4. A Strong Cash and Bank Balance to Provide Runway Beyond 2025

As of June 30th, 2023, the company has a cash and bank balance of RMB1.32 billion. This strong cash and bank balance together with careful spending enables the continuous growth, development, and operation of Antengene beyond 2025.
Antengene plans to release the updated data across its clinical portfolio at the annual R&D Day in November 2023.

To learn more about the interim financial results of 2023, please see the full announcement at: View Source

On August 25, 2023 Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported that the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China (NMPA CDE) has granted priority review of New Drug Application (NDA) for ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody (Press release, Akeso Biopharma, AUG 25, 2023, View Source [SID1234634699]).

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In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.

Previously, CDE has granted Breakthrough Therapy Designation (BTD) for ivonescimab for three lung cancer indications. On August 1, 2023, the first NDA for ivonescimab was accepted by the CDE. The Priority Review process for ivonescimab is a milestone for the clinical value recognition of ivonescimab, which will expedite the process of approval and marketing of ivonescimab.

Ivonescimab is Akeso’s other novel bispecific antibody with a priority review following the marketing approval of cadonilimab (PD-1/CTLA-4 bispecific antibody). Prior to this, the review process for cadonilimab under Priority Review took only 9 months to complete, making it the world’s first approved bispecific antibody drug for cancer immunotherapy.

Following an acceptance of marketing application of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:

A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression (AK112-303), which has been granted BTD in China.
An international multicenter Phase III study of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi/AK112-301), which has been granted BTD in China.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy（AK112-306).
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC (HARMONi-3).
About Ivonescimab

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

On August 25, 2023 Novartis Pharma AG ("Novartis") reported to XOMA Corporation (the "Company" or "XOMA") that it intends to discontinue development activities related to NIS793, an anti-TGFß monoclonal antibody (Press release, Xoma, AUG 25, 2023, View Source [SID1234634698]). Novartis will cease enrolling patients in the remaining active TGFß clinical studies and will collect all data upon conclusion of these studies.

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XOMA licensed NIS793 to Novartis pursuant to that certain License Agreement, dated as of September 30, 2015, by and between XOMA (US) LLC, a wholly owned subsidiary of the Company, and Novartis Institutes for Biomedical Research, Inc., previously filed with the Securities and Exchange Commission as Exhibit 10.2 to its Quarterly Report on Form 10-Q for the period ended September 30, 2015.

NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.

On August 25, 2023 Taiho Pharmaceutical Co., Ltd. (Taiho Pharmaceutical) and Phost’in Therapeutics SAS (Phost’in) reported that the two companies have entered into an option and license agreement through which Taiho Pharmaceutical will obtain option rights to inlicense PhOx430, a First-in-Class small molecule targeting GnT-V (Nacetylglucosaminyltransferase-V) (Press release, Taiho, AUG 25, 2023, View Source [SID1234634697]).

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According to the terms of this agreement, Taiho Pharmaceutical will make an upfront payment to Phost’in. In return, Taiho Pharmaceutical will receive an option right to inlicense PhOx430 and additional undisclosed compounds and to exclusively develop and commercialize the compounds in Japan and certain other territories in Asia (excluding China). When Taiho Pharmaceutical will exercise its option right, the company will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercial milestones. The company will also pay royalties on net sales in its regions.

Phost’in retains the right to develop and commercialize the licensed compounds in other territories, including North America, Europe and China and will be in charge of manufacturing.

"We believe in the potential of Phost’in Therapeutics’s cutting-edge technologies targeting N-glycosylation to bring benefit to the patients in the oncology and fibrosis areas. This agreement resonates with our vision of supporting innovative and highly valuable new drugs to accelerate R&D for significant unmet needs," said Atsushi Azuma, Managing Director at Taiho Pharmaceutical.

Karine Chorro, CEO of Phost’in Therapeutics, remarked "We are very pleased to announce this collaboration with Taiho Pharmaceutical, a leading pharmaceutical company in the oncology area. This demonstrates the value of our targeted first-in-class, small molecule Gnt-V inhibitor approach to the treatment of solid tumours in cancer. We are eager to continue developing this novel approach in collaboration with our new partner".

About PhOx430

PhOx430 is a First-in-Class N-glycosylation inhibitor, designed to target GnT-V, a key nglycosylation enzyme responsible for suppressing the immune response and supporting cancer proliferation as well as formation of fibrotic tissues. PhOx430 is currently evaluated in Europe in a Phase I/II in patients with advanced solid tumors (the PhAST trial). It is also the first program from the Phost’ScreenTM platform that combines unique and patented chemical libraries with cutting-edge screening tools to produce selective nglycosylation inhibitors for the treatment of cancer and other serious immunoinflammatory diseases.