Member Info for Alquemie

That should have read " {NB Primacaine IS NOT prilocaine, but I'm assuming that this is a translation error]

As per the NMPA website, drug approval notifications posted June 15th:

Serial no. 192

Request no. JXHS2500041

Drug Name Lidocaine and Primacaine Aerosol {NB Primacaine IS NOT lidocaine, but I'm assuming that this is a translation error]

Applicant: Shanghai Fosun Pharmaceutical Industry Development Co., Ltd.

Approval No. National Drug Approval Number HJ20260058

Approval Date: June 10, 2026

Again, a general comment, there is certainly PE interest in CDMOs, although largely confined to those with specialist skills- ADC, radiopharma, peptides. Probability of a trade sale dictated by both skill set and locale (and shareholder base, if PE heavy and approaching end of investment cycle).

I can't comment on Evotec as we work with one of their investors. I will make two obvious points relevant to similar CDMOs: Established D&PD units will continue to come under pressure in part due to still fragile early biopharma funding, but also through the switch in big pharma D&PD strategy (look at licensing and acquisition activity for the past year), and the here to stay importance of Chinese innovation to future pipelines.

With respect to biosimilars, ignore the stated originator product market sizes and look hard at the timeline(s) to market entry and active competition. "Expiry" in no way translates into launch year and originator pushback (multi-layered IP, defensive pricing) and PBM shenanigans have profoundly constrained biosimilar penetration in the US, making the time to accrue future revenue, and its quantum, very hard to predict. Operating margins are generally in low double figures.

I had missed that the Phase III bioequivalence study (CTR20242364: Zezheng Biotechnology), where home-grown product was compared directly with Recordati-supplied Fortacin, was completed last summer. Same PI as the Plethora-sponsored study- Dr Hui has been a busy boy. NDA status unknown.

If approved, it would be a Class 3 product (domestic copy of a foreign drug) rather than a true generic, although I'm sure that Fosun would consider it competing in order to reduce the royalty on Senstend, if ever approved. Zezheng is a subsidiary of the CSPC Group, not the minnow I once took it to be.

Can two branded products make money in what is a very modest market? And (in contrast to Recordati), are Fosun and CSPC willing to put up the heavy promo essential to build a market de novo? Domestic product should offer significant cost advantages over an imported version.

@Kendall12 : My amusement arose largely from Bignose's innumeracy and spurious royalty calculation (bizarrely, since repeated) not his understandable ignorance of regulatory process or licensing agreement structure. That said, it's generally wise not to waffle on when understanding is absent, n'est-ce pas?

To repeat, there is little more futile than expecting rational explanation or contrition from the clown alley "managing" RPG, regardless of how barbed or expert that criticism might be, or in believing that "a turnaround" is possible.

I had a good chuckle at the notion that a more nuanced and informed missive than Bignose's Trumpian ramble might effect the raising of an RPG eyebrow.

The reality is that RPG, through a history of backing near worthless assets, amateur deal-making, and total absence of understanding of regulatory and market strategies has no meaningful control over its trajectory.

Forget the whining emails- get the pitchforks and flaming torches out...

Wooo...that should have them spluttering over their foie gras and Château d'Yquem (the 1811, of course).

But, by breadth of rant and degree of miscomprehension alone, up there with the best Truth Social postings.

Do keep up- PSNW went into receivership back in 2023, with the lifeboat company, which acquired most of the staff and assets being liquidated within a year.

While CMC issues were likely compounded by PSNW ineptitude (and appalling project management), the "impurity" issue is inherent, being dealt with through an EMA granted change in specification.

As to gloating over the demise of PSNW, remember it was they who provided clinical trial supply for China, and as is not unusual in contract drug manufacturing, critical know how and CMC data may have been lost. The Taiwan FDA have yet to accept the revised spec, and the NMPA may take the same stance if unconvinced of equivalence between clinical trial supply and commercial supply, or are otherwise unsatisfied with characterisation of the main impurity.

"Bothwell is correct"- on first glance, I thought this had been posted today, the 1st of April.

But, in a troubled world, it's a comfort that such innocent credulity still exists- Santa Claus, the Easter Bunny, US approval, China sales...bless...

"How can they get so many things wrong"- whoo...the irony.

First off, there's been no revision to the Recordati agreement- still 15% net royalty, dropping to 3% or less in February 2028.Net revenues reflect sales to wholesalers (transfer NOT retail price): Wholesaler take up has varied between years and does not directly reflect manufacturing volume- unsold stock can be held over to the next purchase cycle or trashed if short remaining shelf life.

European royalties (as per annual reports, with flat conversion using 0.87 USD to the Euro):

2025= $228,000 (€198,360)

2024= $154,000 (€133,980)

2023= $171,000 (€148,779)

Transfer price to wholesalers is around €16.5 per unit (likely to have increased since 2022, but let's go with it). So, estimating net revenue from the royalty and the number of units delivered to wholesalers:

2025- €1.322m c. 80,000 units

2024- €0.893m c. 54,120 units

2023- €0.993m c. 60,180 units

Assuming no whacking jump in COGS and hence transfer price, Recordati's net profit on Fortacin for 2025 was c.€0.86m (there's no promotional spend). F-gas quotas will increasingly impact on COGS through carbon offset fees and HFA shortage.

European revenues are certainly lower than the wacky baccy-influenced 2019 projection, but by three orders of magnitude, not one.

Of absolutely no relevance, since a US submission will never happen, "regulatory data exclusivity" (more correctly "New Clinical Investigation exclusivity") only "runs out" AFTER product approval. For a non-NCE product without existent patent protection at time of NDA submission, market exclusivity runs for only three years post-approval.

Simples, Bothwell. Formulary inclusion is based on consideration of likely clinical utility and budget implications. Evidence for Fortacin efficacy was universally viewed as weak or ambiguous, hence the blacklisting by NHS England (and Welsh and Scottish equivalents). Recordati declined to undertake post-approval studies and hoped to cut their losses with OTC conversion. That's worked out well...

Did I ever mention the red flags around CMC?

Certainly does do not appear trivial: commercial sample analysis would have been initiated by end July 2025, usually a 60 day process, so an 11 month delay is highly significant. That a possible end is given indicates that one or more specific investigative processes are active, not that RPG would ever offer details. Is it just coincidence that the Taiwan FDA have never accepted the product variation? Orient have never received supply in over three years.

And there's still the non-publication of the Phase III data three years on- very strange given the prolific track record of the lead investigator. No longer a coin toss, now four to one against approval.

Over 8 years since relaunch and Recordati still only shifting around 80,000 units to wholesalers. And that's for an OTC product readily accessible by close to 84 million men across five countries. Less than two years left until even this pittance of a royalty effectively disappears (as an aside, if the CVC acquisition is agreed, a delisted Recordati will likely be broken up, with rationalisation of its bloated low-return OTC portfolio).

Biggest belly laugh was from the DLI blurb though...non-products poised for a non-existent market...priceless...

Twelve years? Closer to 16 years- you're forgetting the Sciele/Shionogi abandonment around 2010 on the basis that there was little hope of satisfying the (still existent) FDA requirement of having a validated co-primary endpoint, a sentiment shared by J&J and Menarini with respect to dapoxetine, along with a handful of small fry with various repurposed offerings. The last, and only, PE drug NDA to be submitted was 22 years ago.

No, he won't. In Silico uses an in-house developed multimodal aging clock, Precious1GPT in its discovery programs.

DL's guess my age biomarker approach is akin to doing complex arithmetic by taking off your your shoes and socks- not fit for any serious purpose other than gulling the dumbest of the worried well. Common knowledge that Zhavoronkov was delighted to get rid of it.

If I could ever bring myself to swallow my professional pride, not a bad gig- handsomely rewarded, with indolence and incompetence clearly held in high esteem, and plenty of scope for recreational activities, such as "See who can micturate the longest over shareholders" and "Most nonsensical comms release" contests.

Against this of course it that they must be struggling to cover the 'leccy bill. Perhaps Jim "Save the Moo-Moo" Mellon will dedicate his Juno book royalties to keep the lights on?

Bless...Bothwell doing pivotal study design...

I've a cheaper and equally credible protocol for you- mail out a thousand samples at random, and it gets approved if it makes three stars on Trustpilot. I mean, what does the FDA know, and who needs all that statistically significant dual endpoint efficacy guff?

Looking at the RPG operational updates, anticipated approval in December 2025 might not have been overly optimistic.NIFDC (or regional equivalent) sampling analysis would have commenced before end July 2025. Only a simple formulation of generic actives, so analysis should have been straightforward: in the absence of other issues, approval might have been as early as November.

So, either 2-3 months overdue, or still two months to go based on average NMPA approval time? Place your bets...

NMPA notifications recommenced on the 24th but as of today, nothing regarding Senstend. If it's any consolation, I'm advised that, based on the actual timeline, notification is still some two months short of the average standard (non-accelerated) imported drug approval time for 2025.

NMPA closure is only 9 days (15th to 23rd). There are a couple of "make-up" days but I don't believe that notices will be sent out until the 24th earliest (in my calendar as we have a couple of Chinese clients waiting for approval notifications...or not).