Daily Brief Health Care: Shanghai Junshi Bioscience, New Ruipeng Pet Group, Edwards Lifesciences, Actinogen Medical, Remegen Co Ltd, Context Therapeutics, Stryker Corp and more

• Shanghai Junshi Bioscience (688180 CH) did not receive FDA approval for toripalimab in US, as the agency could not conduct on-site inspection of the company’s manufacturing facility for the drug.
• Toripalimab (branded as TUOYI) is showing decelerated revenue growth rate in China. Besides being approved for small patient population, TUOYI has seen reduction in price after being included in NRDL.
• In May 2022, the company launched adalimumab biosimilar in China. It marks a late entry in a highly competitive market. COVID-19 oral drug should not bode well for the company.

• New Ruipeng Pet Group, a China-based pet clinic operator and provider of pet care services, filed for a U.S. IPO. The company plans to list ADSs under the ticker “RPET.”
• The company’s most recent private round was a $500M venture round led by Boehringer Ingelheim and Tencent at a ~$4.4B valuation in September 2020. 
• We believe investors should think twice before investing in the New Ruipeng IPO as the pet hospital operator struggled to grow revenues, operating losses mounted, and labor costs increased.

• Despite the healthcare disruptions in several key geographies, Edwards Lifesciences delivered a good result surpassing the analyst consensus estimates in terms of revenues as well as earnings.
• In the quarter Edwards made a series of some external investments in several promising early-stage technologies.
• We provide the stock of Edwards Lifesciences with a ‘Hold’ rating and a revision in the target price.

Actinogen’s recent quarterly update confirmed that the company remains on track to start US recruitment in H1 CY23 for its six-month, placebo-controlled Phase IIb portion of the XanaMIA study. The study is designed to assess the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment (CI) and mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood phosphorylated Tau, or pTau). The company also started enrolment in Q4 CY22 for its XanaCIDD Phase IIa study assessing Xanamem in patients with CI relating to persistent depression despite ongoing treatment with standard-of-care medications. We expect the next material clinical data milestone for the company will be the XanaCIDD results, due in late CY23 or early CY24.

• RemeGen’s revenue declined in 22H2, leading to lower-than-expected performance last year.However, 2022’s low base is good for the growth this year,especially when non-COVID treatment returns to normal after China reopens. 
• We analyzed our revenue forecast on RC48 and RC18. We don’t think there should be big difference between the market value of RemeGen and Akeso. So, RemeGen’s valuation is attractive.
• The sentiment in HKEX has changed this year, so the trading strategy should be different. The pullback could be a buying opportunity, especially for good biotech companies such as RemeGen.

Context Therapeutics has announced that two patients enrolled in the Phase II OATH trial (ONA-XR+anastrozole in advanced endometrial cancer) have achieved partial response (tumor shrinkage) to the treatment. This translates to an overall response rate (ORR) of 22% (two of nine evaluable patients) and strengthens the previously announced positive data from the study (four-month progression free survival (PFS) rate of 77.7%). Management expects to report additional data from the study in Q223 and similar results from a wider cohort should further validate the therapeutic potential of the combination treatment, in our opinion. The beginning of 2023 has been eventful for Context and we expect heightened investor interest given anticipated data readouts from multiple ONA-XR studies (including the SMILE and ELONA trials in breast cancer) later this year.

• Stryker managed to deliver an all-around beat in its recent result despite facing inflationary challenges and unprecedented supply chain challenges.
• The company saw growth in organic sales and interestingly, the international organic growth rate exceeded the company’s U.S. growth rate, demonstrating its globalization progress.
• The great progress of Stryker’s Mako offense resulted in strong growth of its installed base and continued utilization increases.