Biocartis BE0974281132

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1. joe123 27 augustus 2020 08:47

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   Zijn er gegadigden op het forum die willen deelnemen aan deze live webcast?
2. MisterBlues 27 augustus 2020 12:42

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   Joe, ik ga zeker deelnemen. Ik ben erg benieuwd hoe ze er voor staan en wat voor verwachtingen ze uitspreken.
   
   Hoe zit het met die FDA-goedkeuringen?
3. MisterBlues 27 augustus 2020 13:42

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   Managing China’s growing oncology burden
   
   www.mckinsey.com/industries/pharmaceu...
   
   August 26, 2020 | Article
   By Tina Hou, Franck Le Deu, Yi Shao, and Jody Tian
   
   Significant increases in incidence rates have made cancer a high priority in China. Progress has resulted from innovative treatments and greater access to care, yet much more needs to be done.
   
   Article (11 pages)
   
   Cancer is among China’s five high-priority disease areas, 1 with patients experiencing a significant health burden and unmet needs, as emphasized in the Chinese government’s Healthy China Action Plan (2019–2030). Here, more than five people die from cancer every minute. Indeed, roughly 50 percent of the global gastric cancer, hepatocellular carcinoma, and esophageal cancer burden is diagnosed in patients from China. 2 The burden of disease is exacerbated by late diagnosis; approximately 55 percent of patients in China are diagnosed with hepatocellular carcinoma in stages III and IV, compared with 15 percent and 5 percent in the United States and Japan, respectively. 3 China also exhibits a unique epidemiological and patient profile. For example, 61 percent of patients with lung adenocarcinoma in China have a particular EGFR mutation that is seen in only 11 percent of such patients in the United States (Exhibit 1). 4
   ………………………………..
   
   4. China is a global leader in cell therapy
   
   China has a high level of activity in cell-therapy clinical trials and is emerging as a global leader. Cell-therapy development in China is largely driven by academia and hospital-initiated projects: 89 percent of the 84 CAR-T trials 7 initiated during the 12 months between May 2019 and April 2020 belong to this track (Exhibit 6). Like immuno-oncology, cell therapy will be a hypercompetitive market. High-quality manufacturing capabilities and competitive pricing schemes will be important requirements for cell therapy to achieve commercial success in China.
   
   5. Research quality is improving
   
   The improved quality of oncology research in China is gaining recognition, although principal investigators (PIs) in China remain underrepresented globally. The number of oncology articles by Chinese PIs published in the top five journals has grown by 24 percent per year, from 20 articles in 2015 to 47 in 2019. 8 The number of oral presentations by Chinese PIs at American Society of Clinical Oncology (ASCO) meetings also has increased, from only one in 2015 to six in 2019. However, Chinese PIs still account for only 2 percent of all speakers at ASCO meetings. 9
   Biopharmaceutical and biotech companies should step up engagement with Chinese PIs and shape more opportunities for them to lead global programs and innovative studies.
   Transformative shaping of ecosystems will improve oncology-patient access in China
   Although patient access to quality care is improving, fundamental gaps remain. The three main hurdles are late diagnosis, low biomarker testing rates, and varying treatment quality.
   Most patients in China are still diagnosed at a late disease stage (stage III or IV) and have limited access to early screening. For example, the late-stage diagnosis rate in non-small-cell lung cancer is as high as 80 percent. 10 Local governments and pharmaceutical companies are working on early-screening programs for some cancers. Colorectal-cancer screening programs in Shanghai have increased the early-stage diagnosis rate to 53 percent (out of the total diagnosed patients), a fourfold improvement over the previous years.
   Cancer biomarkers have improved the success of oncology treatment, yet the adoption rate of cancer-biomarker testing varies across different hospital tiers in China. Experts tell us that in the top 500 hospitals, the testing rate for key biomarkers such as EGFR and HER2 can reach 80 to 95 percent. However, due to high costs and constrained availability, the rate of next-generation sequencing testing is only 15 percent. Treatment capacities, capabilities, and standards also vary across different classes of hospitals, complicated by the surge in available therapy options.
   
   
4. Flatlander 27 augustus 2020 15:18

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   MB
   Very helpful post! Thanks.
   
   The China market picture becomes cleared every day.
   
   The EGFR mutation rate at 61 % is even higher than the 48% I recall seeing in the past. The high predominance of a single mutation makes Idylla a very cost effective option for first line testing. Single gene testing using Idylla makes sense when there is a high probability that the test will identify the gene defect that allows treatment prescription in day (perfect for AZN's Tagrisso) as opposed to waiting several weeks for NGS. NGS will be necessary when tracking resistance mutations that develop after initial first line treatment. Complimentary usage of these technologies will likely evolve.
   
   I'm optimistic of BCART's potential in China since the the reimbursement system emphasizes costs savings and allows the hospital/ POC provider to mark up and profit from offering cost effective MDx testing. Unfortunately, that reimbursement approval process will take at least another 2 years to play out. This statement suggests that the bulk of the current MDx testing is by PCR methods. Head to head testing suggests that Idylla has numerous advantages over commonly used PCR methods.
   
   " Experts tell us that in the top 500 hospitals, the testing rate for key biomarkers such as EGFR and HER2 can reach 80 to 95 percent. However, due to high costs and constrained availability, the rate of next-generation sequencing testing is only 15 percent. "
   
   Finally. The Gene Therapy angle is also interesting. We have heard nothing about this since the Kite announcement last June.
   
   Next weeks update has a lot of ground to cover!
   FL
   
5. DeZwarteRidder 27 augustus 2020 15:22

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   In China worden bedrijven zoals Biocartis uitgeknepen of opgelicht, dus naar China gaan is een domme fout.
6. Flatlander 27 augustus 2020 16:53

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   MB
   
   This excerpt of the Mckinsey report caught my eye.
   
   "4) Execution, execution, and execution—make time to market the number-one priority. Identify opportunities and pursue initiatives that can accelerate development timelines without compromising quality, through trial-design optimization and innovation, patient-recruitment acceleration, and trial-site capability planning. Though still at a nascent stage, innovative solutions to patient recruitment and trial design have emerged with the introduction of new technologies. For example, cancer-patient recruitment is the main challenge for many pharmaceutical companies, due to the lack of a well-established database in this increasingly competitive market. Leading local data integrators are improving the patient-recruitment process by leveraging their own databases and proprietary AI algorithms to identify the most appropriate patients for recruitment. Using real-world data to reduce recruitment cost while ensuring trial quality could be further explored in China."
   
   BCART already has a relationship with Covance and several large pharma companies who have presences in China. Assistance running clinical trials is Covance's main business.
   www.covance.com/industry-solutions/dr...
   
   The MDx screening of clinical trial candidates is allowed under the RUO designation which WanfoCartis already has. Therefore, Idylla may already be in use for assisting clinical trial enrollment. If this is the case, then BL's statement about the placement of 400 Consoles this year might be logical. If this is the case, BCART will not just be marking time for two years waiting for full IVD registration and waiting for the reimbusement codes to be assigned.
   
   FL
   
7. MisterBlues 27 augustus 2020 17:20

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   FL
   
   Hopefully we'll find out very soon sept. 3.
   
   400 consoles is not easy to hide under a Chinese carpet. :-)
   
   There are indeed many ways in which BCART may come in handy during patient research and recruting in China.
   
   The article ends like this:
   
   For companies building an oncology business in China, the market is still underdeveloped, and success may depend on the right partnerships, local engagement, and acceleration of time to market.
   
8. Phoene 27 augustus 2020 22:26

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   Comment on a post from Biocartis. Seems like Idylla start at Pakistan to.
   
   Idylla is now available at Chughtai Lab , the largest laboratory network in Pakistan! Let's save lives with #septicyte
   
   www.linkedin.com/feed/update/activity...
   
   
9. joe123 28 augustus 2020 12:17

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   quote:

   MisterBlues schreef op 27 augustus 2020 12:42:

   Joe, ik ga zeker deelnemen. Ik ben erg benieuwd hoe ze er voor staan en wat voor verwachtingen ze uitspreken.
   
   Hoe zit het met die FDA-goedkeuringen?
   

   Zeer goed MB.
   Leg Herman Verelst het vuur maar eens goed aan de schenen.
   Benadruk hem maar dat het geduld van de brave particuliere beleggers van het eerste uur bijna op is !!!
10. [verwijderd] 28 augustus 2020 14:16

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    Pakistan...veel volk daar: 233.000.000.
    27 augustus: alweer 2 vacatures
    
    Spannend!
11. MisterBlues 28 augustus 2020 17:28

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    quote:

    joe123 schreef op 28 augustus 2020 12:17:

    [...]
    Zeer goed MB.
    Leg Herman Verelst het vuur maar eens goed aan de schenen.
    Benadruk hem maar dat het geduld van de brave particuliere beleggers van het eerste uur bijna op is !!!
    

    De beleggers van het eerste uur hebben een baard van de kin tot de grond en zitten helemaal onder de spinrag.
    
    Het is vooral de vraag of het erger is dan verwacht wordt of juist beter. Ik denk dat het best wel eens mee kan vallen.
12. FilipVanderAa 28 augustus 2020 23:36

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    MisterBlues, kom jij je hier verstoppen voor Mentie op het Mithra forum :)
13. Flatlander 29 augustus 2020 03:56

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    The more I dig into things it seems reasonable that 400 Idylla units may have been placed in China labs. According to the following they have been placing the units there for the Covance Commercialization agreement for more than a year.. We'll have to listen on Sept 3 to see if they start breaking China and Asia out separately.
    FL
    www.biospace.com/article/biospace-glo...
    
    Biocartis – Belgium-based Biocartis forged a global strategic commercialization agreement with Covance, LabCorp’s Drug Development business. Under terms of the deal, Biocartis’ Idylla platform and its oncology assay will be provided to Covance’s customer base. Several Idylla instruments have already been placed at Covance sites in the US and China to support global oncology trials. Financial details of the agreement are not disclosed.
14. MisterBlues 29 augustus 2020 09:44

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    quote:

    FilipVanderAa schreef op 28 augustus 2020 23:36:

    MisterBlues, kom jij je hier verstoppen voor Mentie op het Mithra forum :)
    

    Lol :)
15. MisterBlues 29 augustus 2020 09:50

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    quote:

    Flatlander schreef op 29 augustus 2020 03:56:

    The more I dig into things it seems reasonable that 400 Idylla units may have been placed in China labs. According to the following they have been placing the units there for the Covance Commercialization agreement for more than a year.. We'll have to listen on Sept 3 to see if they start breaking China and Asia out separately.
    FL
    www.biospace.com/article/biospace-glo...
    
    Biocartis – Belgium-based Biocartis forged a global strategic commercialization agreement with Covance, LabCorp’s Drug Development business. Under terms of the deal, Biocartis’ Idylla platform and its oncology assay will be provided to Covance’s customer base. Several Idylla instruments have already been placed at Covance sites in the US and China to support global oncology trials. Financial details of the agreement are not disclosed.
    

    Het past niet echt bij de aanpak van BCART om hier openheid van zaken te geven. Geografische verdeling: USA en Rest of the world. :)
    
    In het kader van de handelsoorlog zou het ook nog wel eens politiek gevoelig kunnen liggen!? Ik weet wel dat IBA, protontherapie-apparaten een enorme deal heeft gemaakt met China. Waarom dan geen BCART als China nu kanker wil aanpakken, die aldaar epidemische vormen aanneemt?
    
    Ik ben met FL erg benieuwd wat ze hier over gaan zeggen!
    
16. [verwijderd] 29 augustus 2020 12:23

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    Ik twijfelde terug een beperkte positie in BCART te nemen maar wellicht verstandiger om nu toch eerst de halfjaarcijfers maar eens af te wachten.
    Er hangt nog teveel "mist" rondom BCART om enig goed onderbouwde inschatting omtrent mee- of tegenvallende verkopen voorafgaand de cijfers te kunnen inschatten.
    Een pracht bedrijf/product, maar tot het tegendeel eindelijk wordt bewezen ook een eeuwige belofte.
17. [verwijderd] 29 augustus 2020 13:24

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    quote:

    Reply schreef op 29 augustus 2020 12:23:

    Ik twijfelde terug een beperkte positie in BCART te nemen maar wellicht verstandiger om nu toch eerst de halfjaarcijfers maar eens af te wachten.
    Er hangt nog teveel "mist" rondom BCART om enig goed onderbouwde inschatting omtrent mee- of tegenvallende verkopen voorafgaand de cijfers te kunnen inschatten.
    Een pracht bedrijf/product, maar tot het tegendeel eindelijk wordt bewezen ook een eeuwige belofte.
    

    Volledig mee eens, ik heb me enkele maanden geleden beperkt ingekocht.
    Voorlopig geen intentie om mijn positie uit te breiden omdat het gebrek aan transparantie werkt als stoorzender.
    Beleggers hebben het gissen naar de beleidsvoering.
18. Flatlander 29 augustus 2020 13:26

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    The fog is lifting. look at the following points.
    
    1) Wondfocartis announced that 400 labs participated in the Chinese EGFR testing study, in which Idylla received high marks.
    
    2) McKinsey indicates that innovative solutions to patient recruitment and trial design have emerged with the introduction of new technologies. RUO approved tests can be used to assist drug trial enrollment.
    
    3) BCART signs undisclosed terms agreement with Covance, a company who's largest business is conducting drug trials.
    
    4) BCART has CDx partnerships with AZN & BMS who have major drugs they are trying to launch in China. The AZN PR indicate that studies are ongoing "outside Europe" See excerpt from January PR.
    ":The prospective study with the tissue based Idylla™ EGFR Mutation Test (CE-IVD) under the existing partnership was initiated at more than a dozen sites in several European countries. In addition to the new master collaboration agreement, AstraZeneca and Biocartis have agreed to extend this ongoing study to additional countries within and outside Europe."
    
    5) Tagrisso is AZN's #1 drug and it's usefulness is dependent on the EGFR biomarker. Idylla is probably the fastest TAT EGFR test on the market. This mutation is present in anywhere from 43 to 60% of Asians that develop NSCLC. The high prevalence of this mutation makes a single gene test much more viable. Besides McKinsey indicates that NGS availability is much lower in China (I recall available in only 15% of testing facilities).
    
    6)BCART has initiated significant staffing increases that are not justified by the current demand that has been announced in previous calls. This suggests that they will disclose a new development that will justify the increased headcount. The Tagrisso CDx in China probably goes a long way to explaining this headcount increase.
    
    I've added shares this week based on this speculation (I've been putting pieces together thru the week). Oh besides these points, Immunexpress is conducting a Webinar on Sept 11 (911)at the start of a major sepsis conference to discuss the use of Idylla for triaging COVID 19 patients in the ERs. If this doesn't tip off the results of the validation study, I don't know what does.
    
    I've become optimistic enough to break my own rules on position sizing. Certainly BCART has dealt massive disappointment in the past, such that increasing share holdings is a difficult move for many shareholders. However, the the facts are lining up (at least in my mind) that the company is likely to be reaching a transformational point.
    
    FL
    
    '
    
19. [verwijderd] 29 augustus 2020 13:39

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    @Flatlander
    I see your point but it will not be before 3 September that we will know for sure that the fog really is lifting.
20. CGCDLR 29 augustus 2020 13:44

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    Veel succes,FL met je nieuwe aankoop!