Og der var du på pletten ja 
Kan hende det går an å tjene litt mer penger i USA i det minste, da. Det er vel ikke helt utenkelig. Poenget var i utgangspunktet at du ville frådet om kjeften om det dukket opp noe negativt fra fag/forskning.
/ultrahaus
Her er referatet fra Investor Relation møte;
Announcement date: 2026-09-17
Stock Code: 688176 Stock Abbreviation: Yahong
Pharmaceutical Jiangsu Yahong Pharmaceutical Technology Co., Ltd. Investor Relations Activity Record Form
No.: 2026-010
□ Targeted Survey □ Analyst Meeting
Investor Relations Event □ Media Interview □√ Performance Briefing
Event Category: □ Press Conference □ Roadshow Event
□ On-site Visit
□ Other (Please specify other activity content in writing)
Participating Unit Name: STAR Market 2026 Semi-Annual Innovative Drug Industry Collective Performance Briefing
Date: September 16
, 2026, Shanghai Stock Exchange SSE Roadshow Center
(website: http://roadshow.sseinfo.com/).
Chairman and General Manager: Mr.
PAN KE; Listed Company Reception Director, Board Secretary, and Chief Financial Officer: Mr.
Chen Baohua; Personnel Names
: Independent Director: Mr.
Zhang Binghui Main questions and responses exchanged:
The company introduced its situation, main business progress, and future development
plans.
Q1: What are the main drivers of the company’s performance in the first half of the year? Please introduce the scaling up of
core product commercialization. Can Commercial Capacity (Self-owned/Contract Manufacturing)
Investor Relations Match the Volume Growth Pace?
Main content of the movement: Introduction
to Shao Reply:
Dear investor, hello. The company achieved operating revenue
of 155.3533 million yuan in the first half of the year, mainly due to steady advancement of Commercialization 2.0 upgrades,
further improving the commercialization system, continuously enhancing commercialization efficiency, optimizing market strategies
and implementation quality, and steadily advancing Ouyoubi’s ® commercialization promotion during the reporting period.
CEVIRA/Cevira ®® Achieving commercial sales. During the reporting period, Xiweita ®
was approved for market launch by the National Medical Products Administration in March 2026, became
the world’s first to launch in Beijing in June
, and within 10 days rolled out in 70 hospitals
across 30 cities nationwide The first party simultaneously achieved its first online launch on JD Health. The company focuses on public hospitals as its core for an omnichannel commercial layout, having built a professional promotion team of over 100 people focused on the education of photodynamic therapy doctors and the dissemination of clinical evidence, comprising medicine, marketing, and sales. Already marketed products like Ouyou Bi ® have also made breakthroughs in market access for dual-channel pharmacies. For detailed operating information, please refer to the company’s “2026 Interim Report” disclosed on August 29, 2026.
Q2:
What is the promotion and sales situation of Xiwei 1702 in China during July~September? How much was the total monthly sales in August? How much new sales revenue is there? By September 15, how many hospitals had been promoted and how many bottles had been sold per hospital on average?
Reply:
Dear investor, hello. The company’s product, Xiweita ®, is currently focusing on public hospitals as the core for an omni-channel commercial layout. It has established a professional promotion team of over 100 people focused on the education of photodynamic therapy doctors and clinical evidence dissemination, composed of medicine, marketing, and sales, as well as complete commercialization support departments covering government affairs, market access, business, and supply chain. At the same time, it promotes the implementation of full-domain business in broad markets through commercial partners. For specific operating conditions, please refer to the company’s subsequent periodic reports and related announcements. Thank you for your attention.
Q3: Did Company 1702 Xiwei participate in the medical insurance
selection negotiations on September 5~10? Please also introduce the necessity and feasibility of being included in medical insurance for 2026~2027, as well as the company’s arrangements. Also, roughly when will the BD 1702 be available in Europe?
Reply:
Dear investor, hello. For information related to medical insurance, please refer to the information published by the National Healthcare Security Administration. In the European market, Xiweita’s ® marketing authorization application has been successfully accepted by the European Medicines Agency and will actively seek overseas commercialization partners in Europe and emerging markets. For subsequent developments in the above matters, the company will strictly fulfill its information disclosure obligations in accordance with the “Shanghai Stock Exchange STAR Market Listing Rules” and other relevant regulations.
Q4: 1. Recently, media reported that Beilian Biotech, a subsidiary of Yahong Pharmaceuticals, received
angel round financing from Hengxu Capital to advance domestic clinical trials for the APL-2501 pipeline. What is the amount of angel round financing? Will its U.S. subsidiary Baylink Biosciences also independently raise funds to advance …
Ja, det er jo rart at ikke alle som en tar bølgen når det kommer en pressemelding om ting som ble presentert på en konferanse i 2025 
That’s you, hva med å eie det.
Hentet fra Nykode-tråden:
Hvis Photocure skulle laget en tilsvarende, hvilke argumenter skulle de hatt?
Ville hatt med nysatsingen medicare refusjon AssureMDX og medicare refusjon. Mulighet for shortskvis😆
Noen som kjenner til hvor FDA nedklassifisering av teknisk utstyr offentliggjøres?
Skulle vel tro det var her :
https://www.federalregister.gov/
Samt du kan følge saken her :
https://www.regulations.gov/search?searchTerm=FDA-2026-N-8249
Her er final response fra FDA v/ Karl Stortz sin Petition. ( anbefaler alle å lese denne)
https://downloads.regulations.gov/FDA-2022-P-2644-0046/attachment_1.pdf
Skjønner ikke hvorfor du fortsetter å dra opp dette avslaget som KZ fikk fra FDA. Det er historie og helt irrelevant på dette tidspunkt da FDA nå har tatt roret selv får å nedklassifisere utstyret.
Avslaget til KZ ble publisert 28 mars:
13 april kom FDA med melding om at dem ville jobbe for å nedklassifisere utstyret på eget initiativ.
14 august kom det ny melding fra FDA et dem nå hadde levert en proposed order for nedklassifisering. Dette er nå ute med 60 dagers høringsfrist (midten av oktober), med etterfølgende 1-3 måneder behandlingstid for å gå igjennom kommentarer. Med tanke på at FDA selv har tatt styringen, leger, produsenter osv. var positive ifbm. KZ sin søknad, skal det mye til for at dette ikke blir noe av :
Du må gjerne fortsette å gnåle om avslaget KZ fikk i Mars, men det er helt feil fokus og historie. Med tanke på behandlingstid for FDA’s “proposed order” er vi potensielt nærmere en nedklassifisering en avslaget fra Mars du maser om.
Bro, slow down.
Du har helt rett at avslaget er historie, å at det allerede er priset inn osv osv.
Men er jo allikevel interessant å lese detaljer om hva som ligger bak avslaget?
En detaljert begrunnelse har ikke vært publisert hverken her ( før nå), eller av Photocure.
For de som leser både ris og ros, velbekomme,
For rocket’s only gjengen, keep scrolling!
For å være helt ærlig. Nei, det har liten eller ingen verdi på dette tidspunkt.
Hadde du bare postet det og latt det være med det så hadde jeg ikke reagert. Men er vel 5. eller 6. gangen du drar opp avslaget KZ fikk på søknaden sin.
Når du på slutten legger til “(anbefaler alle å lese denne)” som om det er en “smoking gun” gjemt i avslaget blir det for dumt.
Realiteten er at man er nærmere beslutningen til FDA’s egen prosess for nedklassifisering en man er for KZ’s avslag tilbake i mars.
Så får man bestemme selv hva man synes er viktigere og fokusere på det.
Peace out 
Mange måter å se dette på.
Fordelen med å lese begrunnelsen for avslaget, er jo at man kan lette i dokumentet som nå er relevant/publisert i FDA sin prosess.
https://www.regulations.gov/search?searchTerm=FDA-2026-N-8249
Skulle da tro kriteriene som ble påpekt i avslaget, er like relevant for pågående prossess?
Forskjellen er jo at det er dem som avslo søknaden som nå er dem som kjører prosessen.
Forslaget er allerede ute til høring.
Prosessen til FDA’s eget initiativ og KZ’s søknad er to helt forskjellige prosesser.
Det som er interessant er jo å følge med på kommentarene som kommer inn i høringen. Foreløpig kun 1 kommentar, som støtter omklassifiseringen.
Er kommentaren åpen? Eller er innholdet skjult?
Kan du linke til den.
Re svaret ditt, jada, helt enig med deg, nå er det FDA som styrer prosessen. Å setter kravene til leverandørene. Hva disse kravene blir, kan man derimot få en bedere forståelse av, ved å lese avslaget.
Men nok om det, var kun delt som informasjon, på lik linje med de andre linkene som henviser til pågående prossess. Beklager at du ikke likte det.
Den var i listen av dokument du refererte til:
TL:DR
Støtter omklassifisering. Men vil ha en mer presis definisjon på enkelte parameter. Og vil ha forskjellen på FDA’s initiativ og KZ’s søknad, da det ikke kommer frem i forslaget.
https://www.regulations.gov/document/FDA-2026-N-8249-0001/comment
Mulig en issue med å finne den via mobil.
Linken gir kun feilmelding.
Står det hvilket selskap/individ som står bak kommentaren?
Lukter KZ*ansatt 
Takker, et raskt søk via AI, tyder på at han ikke har noe relasjon til KZ, han har vist kommentert på mange saker hos FDA.
Kommentar merket (#) deler jeg Steven sin interesse for, ikke lenge siden begrunnelsen for avslag kom, hva har endret seg siden?
Kommentaren i sin helhet :
This proposed order reclassifies diagnostic endoscopic light source systems (product code OAY) from class III to class II under a new regulation, 21 CFR 876.1560, renamed “Cystoscopic system intended as an aid for detection of bladder cancer.” Section V and Table 1 tie each of the six identified risks to health to a specific special control – false positive/negative results to clinical data and labeling, device failure to non-clinical testing and software hazard analysis, infection risk to sterilization validation, and so on. That risk-by-risk mapping is the right structure for a reclassification: it lets a reader trace each proposed 876.1560(b) requirement back to a documented hazard rather than a generic checklist.
(#) That same traceability does not fully carry through to two places in the record. The first is procedural. In October 2022, the PDD System’s manufacturer petitioned FDA to reclassify product code OAY from class III to class II (Docket FDA-2022-P-2644), including a February 2024 draft special control guidance submission. On March 27, 2026, FDA denied that petition because it “did not agree that the information provided and the special controls proposed by the petitioner supported reclassification.” Less than five months later, FDA is proposing the identical reclassification on its own initiative. A change in outcome is not itself irregular – but the notice does not say what changed in the evidence, or how the special controls proposed here differ from the ones the petitioner offered and FDA found insufficient. Stating that basis in the final order would let the record show what actually moved the outcome, rather than leaving readers to infer it.(#)
The second gap sits inside the special controls themselves. FDA’s MAUDE review found 11 unique MDRs for product code OAY as of April 30, 2026, and reports that “most of the adverse events were related to thermal injury from contact with the light cable.” The corresponding special control, proposed 876.1560(b)(3), requires performance testing that demonstrates “electrical, mechanical, thermal, and optical safety” generally, without a quantified thermal threshold – a maximum light-cable surface temperature or permissible contact duration – tied to that specific, dominant failure mode. Given that this one hazard accounts for most of the adverse event history FDA relied on to support reclassification, anchoring the thermal-safety testing to a measurable limit, referencing an applicable electrical-safety standard, would close the loop between the documented harm and an enforceable engineering requirement rather than leaving “thermal safety” for each 510(k) submitter to define.
A third gap sits in the same MDR data. Two of the 11 reports found that “the blue light mode stopped working after the first use” – a first-use reliability failure on a device with reusable, reprocessable components. Proposed 876.1560(b)(2) requires testing showing the device “performs as intended under anticipated conditions of use,” and (b)(5) adds software verification and hazard analysis, but neither is framed as a durability or repeated-use test, and a first-use light-source failure is not obviously a software defect. Clarifying that (b)(2) covers functional reliability across the device’s intended use cycle, not only a single-use bench demonstration, would tie the control back to that specific failure mode.
A related question follows from where the underlying data comes from. Every clinical and non-clinical performance parameter cited in Sections IV through VI – illumination spectrum and intensity, filter specifications, excitation power and density, optical performance – derives from a single approved device-drug combination, the PDD System with CYSVIEW, the only product ever cleared under this product code. The reclassification and the resulting 510(k) pathway will apply broadly to any future product-code-OAY device using any compatible optical imaging agent. Stating the (b)(2) performance parameters as device-agnostic, quantifiable acceptance criteria, rather than criteria benchmarked only against the incumbent’s own specifications, would let a new entrant with a different light source or imaging agent know what standard it is actually held to.
None of this counsels against reclassification; the risk-to-control mapping in Table 1 shows the underlying framework is sound. These points ask FDA to extend that same specificity to the procedural basis for the reversal, the thermal-injury and reliability controls, and the device-agnostic framing of the technical parameters before the order is finalized.
