Jeg er uenig med Erik, i denne meldingen kom det ny informasjon vedrørende NÅR resultatene av Cevira fase 3 studiet skulle publiseres, ikke bare at de skulle etablere en ny avdeling. Altså betydelig informasjon for markedet spør du meg.
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Helt enig! Det er vi «alle» enig i at det var! Men PHO lover bedring.
Urettferdig at så få i markedet fikk plukket opp meldingen til partneren Asieris.
Den burde også kommet fra PHO. Ingen jeg har pratet med er uenig i at PHO burde meldt dette😊. Godt tekinvestorer fikk med seg oppdateringen fra Asieris. En liten trøst, men urettferdig.
Alle momenter som ble beskrevet i melding fra partneren er samlet sett svært verdidrivende for asset Cevira og verdsettelse av dette mener jeg og også fra tilbakemelding i mail fra selskapet (beklager og lover bedring med work in progress kommentar)? Vi snakker tross alt om fase III oppnådde endepunkter og safety profil som nå aktivt jobber med markedstilgang og kommersialiseringsjobb med økte investeringer. Myndigheter beskrives også å være «på lag» med nasjonale vedtatte initiativ og int kvinnehelse. Du skal være rimelig nedsnødd om ikke det er verdifull informasjon om et produkt som er svært nære å kunne komme i salg i et mulig stort marked?
Tipper ledelsen jobber med mye om dagen. Det glapp med denne meldingen fra Asieris. Det tok for lang tid før de agerte og sendte ut en pressenyhet og dermed lover de fremover bedring med partnernyheter og work in progress med infoflyt.
Det er ikke vanskelig å følge logikken til Dahl. Han har nok rett i at det faktum at det at Asieris opprettet en forretningsenhet sier egentlig ikke noe nytt om Cevira som rettferdiggjør en børsmelding fra PHO.
Samtidig så må det være lov å bruke sin egen logikk. Og den mest logiske slutningen som kan trekkes er at Asieris aldri ville opprettet en egen forretningsenhet for Cevira dersom det ikke hadde en direkte sammenheng med positive resultater med Cevira.
Så selv om PHO ikke har nødvendig grunnlag for å sende ut egen børsmelding, så er det sterke indisier som tilsier at Asieris har lykkes med Cevira og at produktet ligger an til å bli godkjent for salg.
Dette får vi høyst sannsynlig bekreftet om få uker.
Men når det kommer til avlesning av Fase III resultatene så burde nok PHO konkludert annerledes, som påpekt av andre.
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Sterke indisier? Vi vet jo at fase III studien møtte primærendepunkt og at det jobbes med NDA.
Logikk? Det er jo ikke noe å lure på. Det står svart på hvitt at enheten sentreres rundt Cevira som er en av de viktigste assetene til Asieris. I tillegg skal de ekspandere
« Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women’s health.»
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Om det ikke kvalifiserer til børsmelding så er jo pressemelding et bra alternativ.
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Alle som kjenner til den enorme utfordringen Kina står ovenfor vedrørende arbeidskraft etter konsekvensene av ettbarnspolitikken, skjønner at Cevira kommer til å bli en enorm suksess.
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At kinesiske damer ikke får barn er faktisk på toppen av lista av bekymringer for CCP.
Birth rate for Kina 2023 kom i går:
https://www.wsj.com/world/china/chinas-population-decline-accelerated-last-year-a5096672
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På kort sikt sliter jo Kina litt. Arbeidsledigheten endte i desember på 5,1 prosent, opp fra 5 prosent måneden før. Blant unge mellom 16 og 24 var den vel over 14 prosent.
Men Kinas lederskap er åpenbart bekymret for tiden. I fjor ble det for andre år på rad nedgang i befolkningen. Nedgangen var på 2,75 millioner mennesker. Det er langt flere enn den på 850.000 i 2022, som da var den første nedgangen siden 1961.
Så alt som kan bidra til å snu trenden, inklusive Cevira, er nok kjærkomment.
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Problemet er at pga ettbarnspolitikken ville de fleste ha guttebarn for å ha noen som kunne forsørge familien i fremtiden. Hvordan det ble praktisert er en annen historie, men det har ført til at ratio kvinner:menn er helt ute å kjøre, og med en arbeidsstokk som er aldrende så er arbeidskraft en mangelvare i Kina.
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Stock Code: 688176
Stock Abbreviation: Yahong Medicine
Jiangsu Yahong Medicine Technology Co., Ltd. Investor Relations Activity Record Form
Number: 2024-001
Investor Relations Activity Type
Specific Object Research □ Analyst Meeting
□ Media Interview □ Performance Briefing
□ Press Conference □ Roadshow Event
□ On-site Visit
□ Other (Please describe other activities in text)
Participating Units: Southwest Securities, Dongwu Securities, Golden Eagle Fund, Great Wall Fund, Huabao Fund, ICBC Ruijin, Shangtou Morgan, Ping An Fund, Tianhong Fund.
Dates: January 11, 2023, January 12, 2024
Location: Online Meeting
Listed Company Reception
Personnel Names
Board Secretary, CFO: Yang Mingyuan
Investor Relations Director: Chen Juan
Investor Relations Activity
Main Content Introduction
Key Issues Discussed and Responses:
The company introduced its corporate situation, major business developments, key financial information, and future development plans.
Question 1: How is the progress of the APL-1202 clinical trials?
Answer: APL-1202 is currently undergoing three key clinical trials. The Phase I/II clinical trial for APL-1202 oral combined with trastuzumab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) was completed in September 2023, with positive interim results. The results of this analysis will be disclosed at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU). APL-1202 combined with chemotherapy infusion for the critical clinical trial in the treatment of recurrent high-risk NMIBC is actively preparing for data cleaning. The Phase III clinical trial of APL-1202 monotherapy for untreated intermediate-risk NMIBC is actively recruiting subjects. The company will disclose subsequent clinical results in accordance with relevant regulations and disclosure obligations.
Question 2: What is the plan for APL-1202’s foreign clinical development?
Answer: APL-1202’s overseas development primarily focuses on the clinical trial of trastuzumab combined with APL-1202 as neoadjuvant therapy for MIBC. The trial completed the Phase II clinical trial analysis in September, with positive results. The results will be disclosed at the 2024 ASCO-GU annual meeting. The company will formulate subsequent clinical development plans based on the results of this trial.
Question 3: How is the current competitive landscape for APL-1202?
Answer: Currently, there is no oral drug for the treatment of non-muscle-invasive bladder cancer (NMIBC) globally. Apart from Merck’s Keytruda® receiving FDA conditional approval in January 2020 and Ferring Pharmaceuticals’ Adstiladrin® gaining FDA approval in April 2023, both drugs for the treatment of BCG-unresponsive, high-risk NMIBC, with or without papillary tumors, and not suitable for or unwilling to undergo bladder removal surgery, there are no other newly approved drugs in the NMIBC treatment field.
Question 4: When will APL-1702’s Phase III clinical trial results be disclosed? When is the NDA? How will pricing be determined in the future?
Answer: APL-1702, used to treat advanced cervical high-grade squamous intraepithelial lesions, has completed its international multicenter Phase III clinical trial and will disclose the trial data at the 2024 EUROGIN conference. The company will actively communicate with regulatory authorities to submit the new drug marketing application. Regarding NDA, the company will fulfill disclosure obligations in accordance with the Shanghai Stock Exchange Science and Technology Innovation Board Listing Rules and other relevant regulations. Currently, traditional surgical methods are the main treatment for precancerous lesions of cervical cancer patients. APL-1702 will consider various factors such as the comprehensive cost of traditional surgical treatment, the innovation of the product itself, pharmacoeconomic evaluation, and patient payment capacity for pricing.
Question 5: When will APL-1706 go for NDA?
Answer: The company announced in November 2023 that the NDA for APL-1706 (generic name: intravesical ammonium chloride hexylate) for the diagnosis and management of bladder cancer has been accepted by the National Medical Products Administration (NMPA). Regarding the subsequent situation of NDA, the company will fulfill disclosure obligations in a timely manner according to relevant regulations.
Question 6: What are the plans for the company’s anti-infective product APL-2301?
Answer: APL-2301 is a new mechanism of action antibacterial drug developed by the company for the treatment of infections caused by Acinetobacter baumannii. It has been approved for Phase I clinical trials in Australia. Considering that the anti-infective pipeline is not the company’s focus area, the company will seek external cooperation and other methods for subsequent development.
Question 7: What is the market space for the two products, posaconazole tablets, and neratinib maleate tablets introduced by the company?
Answer: The company introduced posaconazole tablets (trade name: Dipart®) and neratinib maleate tablets (trade name: Oyobi®) focusing on the urogenital field. Through the commercialization of these two drugs, the company aims to build a strong commercialization team, optimize the commercialization operating system, accumulate experience through practice, and cultivate a more professional and mature team to meet the landing of core strategic products, benefiting more patients. Posaconazole tablets are a multi-target tyrosine kinase inhibitor (TKI) used for the first-line treatment of advanced renal cell carcinoma and for the treatment of advanced renal cell carcinoma patients who have received cytokine therapy. The Chinese Society of Clinical Oncology (CSCO) recommends posaconazole monotherapy as the standard first-line treatment for advanced renal cell carcinoma. Neratinib maleate tablets are an irreversible pan-epidermal growth factor receptor (HER2) TKI, suitable for adult patients with HER2-positive early-stage breast cancer undergoing enhanced adjuvant therapy after receiving trastuzumab. The latest CSCO “Breast Cancer Diagnosis and Treatment Guidelines” and “Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Norms” recommend neratinib for the postoperative enhanced adjuvant treatment of lymph node-positive patients. In addition, posaconazole tablets were officially prescribed in Shanghai in October 2023, and neratinib maleate tablets have recently landed. The company will continue to actively promote the market, and for the commercial revenue of the two products, the company will strictly fulfill disclosure obligations in accordance with the Shanghai Stock Exchange Science and Technology Innovation Board Listing Rules and other relevant regulations.
Question 8: How is the company’s commercialization progress?
Answer: The company has initially established a commercialization team consisting of departments such as medical affairs, market access, sales, marketing, business, digital operations, and sales effectiveness. The company aims to benefit more patients through efficient commercialization operations and practical accumulation, building a more professional and mature team to meet the landing of core products. Additionally, to accelerate the strategic layout in the field of women’s health, the company has added the Women’s Health Division during the commercialization phase. Based on the positioning of diagnosis and treatment integration, the company independently established the “Miyi Hui” online doctor service
kilde: 江苏亚虹医药科技股份有限公司投资者关系活动记录表（2024年1月11日、1月12日） - Jiangsu Yahong Meditechannouncement - Moomoo
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Security Code: 688176
Security Abbreviation: YAHONG MEDICINE
Jiangsu YAHONG Medicine Technology Co., Ltd.
Investor Relations Activity Record Form
Number: 2024-002
Investor Relations Activity Type:
Specific Object Research □ Analyst Meeting
□ Media Interview □ Performance Briefing
□ Press Conference □ Roadshow Event
□ On-site Visit
□ Other (Please describe other activities in words)
Participating Units:
Southwest Securities, Huashang Fund, Pengyang Fund, ICBC Credit Suisse Fund, Haitong Securities, Guolian Fund, Zhaohong Fund, Xinpeng Investment, China Post Fund, Western Profit Fund.
Time: January 15, 2024, January 16, 2024, January 17, 2024
Location: Online Meeting, Company Conference Room
Listed Company Reception Personnel:
Board Secretary, CFO: Yang Mingyuan
Securities Affairs Representative: Ji De
Investor Relations Director: Chen Juan
Main Content of Investor Relations Activity Introduction:
Major Questions and Answers:
The company introduced its corporate situation, main business progress, major financial situations, and future development plans.
Question 1: How is the progress of APL-1202 clinical trials? When will the results of the key clinical trial using APL-1202 in combination with chemotherapy infusion for recurrent high-risk NMIBC be disclosed?
Answer: APL-1202 is currently conducting three key clinical trials. The Phase I/II clinical trial of APL-1202 oral administration in combination with trastuzumab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) was completed in September 2023, with positive interim results. The analysis results of this trial will be disclosed at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU). The key clinical trial of APL-1202 in combination with chemotherapy infusion for recurrent high-risk NMIBC is actively preparing for data cleaning. The Phase III clinical trial of APL-1202 monotherapy for untreated intermediate-risk NMIBC is actively recruiting subjects. Regarding subsequent clinical results, the company will fulfill its disclosure obligations in a timely manner according to relevant regulations.
Question 2: What is the market potential for APL-1202? How is the current competitive landscape?
Answer: According to Frost & Sullivan analysis, the global number of new bladder cancer patients increased from 520,000 in 2016 to 573,000 in 2020, and is expected to reach 651,000 by 2025 and 736,000 by 2030. The number of new bladder cancer patients in China increased from 77,000 in 2016 to 86,000 in 2020, and is expected to reach 101,000 by 2025 and 118,000 by 2030. Due to the long survival period of NMIBC patients, the number of existing patients is much larger than the annual number of new patients. Currently, there is no oral drug for the treatment of non-muscle-invasive bladder cancer (NMIBC) on the market globally. In recent years, Keytruda® (pembrolizumab) by Merck received conditional FDA approval in January 2020, and Adstiladrin® by Ferring Pharmaceuticals received FDA approval in April 2023. Both drugs are used to treat carcinoma in situ (CIS) of NMIBC with or without papillary tumors, which is refractory to Bacillus Calmette-Guérin (BCG) therapy, is at high risk, and is unsuitable or unwilling for cystectomy. There are no other newly approved drugs in the NMIBC treatment field.
Question 3: Will APL-1202 continue international clinical trials?
Answer: APL-1202 is mainly conducting clinical trials abroad, focusing on the neoadjuvant therapy of muscle-invasive bladder cancer (MIBC) in combination with trastuzumab. The trial completed the Phase II clinical trial analysis in September, obtaining positive results. The interim analysis results of this trial will be disclosed at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU). In the future, the company will formulate follow-up clinical development plans based on the results of this clinical trial.
Question 4: How is the clinical trial data for APL-1702?
Answer: The international multicenter Phase III clinical trial of APL-1702 for the treatment of high-grade squamous intraepithelial lesions of the cervix has achieved the main research endpoints, and the data from this trial will be disclosed at the 2024 EUROGIN Congress.
Question 5: When will APL-1702 be approved for marketing? How will it be priced in the future?
Answer: The international multicenter Phase III clinical trial of APL-1702 for the treatment of high-grade squamous intraepithelial lesions of the cervix has achieved the main research endpoints. The company will actively communicate with regulatory authorities to submit the new drug marketing application for this drug. Regarding the relevant information of the New Drug Application (NDA), the company will strictly comply with the rules of the Shanghai Stock Exchange Sci-Tech Innovation Board and other relevant regulations to fulfill its disclosure obligations.
Currently, traditional surgical methods are mainly used for the treatment of precancerous lesions of cervical cancer, including loop electrosurgical excision procedure (LEEP) and cold knife cone biopsy (CKC). There are no non-surgical treatment products on the market. In the future, the pricing of APL-1702 will consider factors such as the comprehensive cost of traditional surgical treatment, the innovation and pharmacoeconomic evaluation of the product itself, and the ability of patients to pay.
Question 6: Why did the company introduce pazopanib tablets and neratinib maleate tablets?
Answer: The company introduced pazopanib tablets (trade name: Dipatte®) and neratinib maleate tablets (trade name: Oyobi®) in the field of urogenital specialization. The commercial landing of these two drugs will be used to train a strong commercialization team, further optimize the commercialization operation system, and accumulate experience through practice. It aims to refine the company’s collaborative combat capability in commercialization to welcome the landing of core strategic products and benefit more patients.
Attachment List (if any): None
Date: January 17, 2024
Kilde: 江苏亚虹医药科技股份有限公司投资者关系活动记录表（2024年1月15日、1月16日、1月17日） - Jiangsu Yahong Meditechannouncement - Moomoo
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Hva er dette ?
Høres ut som cash money heroes
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APL-1706 er Hexvix og APL-1702 er Cevira. Begge utlisensiert til Asieris fra Photocure. Snart er begge produktene i salg i Kina. Milestones og royalties venter…
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Virker som at investorer tror at det ikke blir å komme noen Cevira nyheter før dataene presenteres i mars, mens virkeligheten er at NDA søknad kan bli levert når som helst.
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Photocure Partner Asieris to present unpublished clinical trial and real-world data on Hexvix in China at ASCO GU 2024
Photocure ASA, The Bladder Cancer Company, announces that its partner Asieris plans to present two studies in the field of bladder cancer at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), January 25-27 in San Francisco.
This includes a poster presentation of heretofore unpublished data from the Hexvix real-world evidence study in China (Abstract 593): “Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of Unpublished Clinical Trial and Real-World evidence.
Kan det tenkes at Asieris kommer opp med noe nytt når det gjelder dette med terapeutisk effekt? Får vi mer kjøtt på beinet? 
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Nei, dette er ikke en del av studien.
Om en skal tillate seg å spekulere - hva kan det være som har ytterligere betydning i disse hittil ikke-publiserte «dataene» ?
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Spekulere er vel i overkant, men siden du du gjør det, spekulerer jeg på om Hexvix i China og EU kan brukes i surveillance merkedet med flexible scope som er godkjente. Vi venter på nedklassifisering i US slik at surveillance markedet blir tilgjengelig for Cysview med scope som da kan brukes.
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