Goby Asia Healthcare Weekly 6/25

Highlights of the Week

Financial Times reported that AstraZeneca has drawn up plans to break up its China business and list it separately in Hong Kong as a way to deal with geopolitical tensions. The publisher of this weekly newsletter did a survey on LinkedIn to gather opinions about when or if this would take place. Opinions were divided; the largest vote (39%) from the total of 18 respondents was in favor of this change happening within a year. Read more here and here.

The United States of America has become the second country in the world, after Singapore, to allow the sale of cultivated lab-grown meat. Upside Foods and Good Meat announced that the US Department of Agriculture issued them final approval to sell lab-grown meat, clearing the path for the first-ever domestic sales of the product. Read more here.

The U.S. FDA is working with Qilu, a Chinese drugmaker, to import the chemotherapy drug cisplatin to ramp up supply amid an ongoing shortage of the drug in the United States. The FDA is also exploring importing carboplatin, another chemotherapy drug in shortage. The U.S. faces a widespread shortage of more than a dozen cancer drugs. Read more here.

Lunit Inc (KOSDAQ: 328310) is the best weekly gainer this week in the Asia-Pacific, returning 42.8%. Lunit is an AI software company devoted to developing AI solutions for precision diagnostics and therapeutics, to find the right diagnosis at the right cost, and the right treatment for the right patients. It is developing advanced medical image analytics and data-driven imaging. The company was listed on the Korean Stock Exchange in July 2022 at a price of 30,000 KRW. Less than a year later, it is at 142,200, almost 5x its IPO price. We can not find anything company-specific that explains the performance. It is most likely driven by the “AI” concept.?

Hua Medicine (HKEX: 2552) is the worst weekly performer this week in the Asia-Pacific. No specific news this week for Hua either. However, we noticed that Hua has lost about two-thirds of its value since early February 2023. One can speculate that sales of its approved gluokinase activator HuaTangNing is below expectation. Please see the table at beginning for other market movers for the past week.

The Shanghai Stock Exchange approved potentially the largest IPO in the world this year, the $9.1 billion IPO for Sygenta Group, a Chinese seed company with headquarters in Basel, Switzerland. In 2017, Chinese state company Sinochem acquired Sygenta for $43 billion, making it China's largest foreign acquisition. In 2019, Sygenta began working toward an IPO. Read more here.

Pharmcyclics Ltd., an AbbVie Inc. owned company, filed a patent infringement complaint against BeiGene for Brukinsa, BeiGene's blood cancer therapy. Pharmcyclics developed Imbruvica, its own blood cancer therapy, in conjunction with J&J. A recent study conducted by BeiGene comparing the two therapies reported superior efficacy and safety for Brukinsa over Imbruvica. BeiGene has also issued a denial of the patent infringement claim by Pharmcyclics/AbbVie. Read more here.

Russian news media reported that the Bank of China has restricted transactions involving Chinese Yuan for Russian bank clients to banks located in the EU, US, Switzerland, and the UK. The bank or Chinese government did not confirm or issue any statement on this matter. ?Read more here.

Adicon Holdings Ltd., a mainland Chinese laboratory chain backed by Carlyle Group, is seeking to raise HK$409 million from an initial public offering (IPO) in Hong Kong. The Hangzhou-based company plans to sell 32 million shares at HK$12.32 each, with trading expected to begin on June 30. The company tried to list twice between 2021-22 on the exchange. Read more here and here

I-Mab [NASDAQ: IMAB] appointed Raj Kannan as the Company's new Chief Executive Officer and a member of the board of directors, effective June 22, 2023. Raj?has a track record for successful M&A. There was also a rumor that I-Mab was for sale a few months ago. Coincidence? Read more here.

Hong Kong Exchanges and Clearing Limited (HKEX) opened its first North American office in New York at the Rockefeller Center. Read more here.

HKEX announced that it has launched the HKD-RMB Dual Counter Model to the secondary market for trading and settlement purposes on 19 June 2023. The Mode allows selected securities to be traded in both currencies. An initial group of 24 companies based in mainland or Hong Kong, such as China Mobile, were selected.?Read more here.

Greater China News

Clinical & Regulatory

Sirnaomics advanced STP705, a treatment for Squamous Cell Carcinoma in situ, into late-stage clinical development after an encouraging End of Phase-2 meeting with the U.S. FDA. Read more here.

BioCity initiated a Phase 2 trial of SC006, a novel oral endothelin receptor selective antagonist, and enrolled two patients with IgA nephropathy in China to assess the safety and preliminary efficacy of SC0062 relative to placebo in patients with chronic kidney disease with albuminuria. Read more here.

Minghui Pharmaceutical?dosed the first patient in Phase 1 clinical studies of two ADC programs targeting TROP-2 or B7-H3 to treat advanced or metastatic solid tumors. Read more here.

Presentations?

Gracell Biotechnologies announced its management team will participate and host investor meetings at the Truist Securities Cell Therapy Symposium: Symposia-cel on June 27, 2023, in New York, NY. Read more here.

Foresee Pharmaceuticals presented a poster at the June 19-21, 2023 WASOG International Conference on Sarcoidosis and Interstitial Lung Diseases on MMP-12 in a cardiac sarcoidosis mouse model, showing that Inhibiting MMP-12 with FP-020 attenuated macrophage infiltration, macrophage clustering, decreased fibrotic replacement, and reduced the number of activated fibroblasts. Read more here.

Everest Medicines announced its partner Calliditas Therapeutics AB made presentations on data from the NeflgArd Phase 3 Study at the European Dialysis and Transplant Association Congress in Milan, Italy from June 15-18. The presentation showed that the study met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug. Read more here.

Greater Asia News

Japan

Jadeite Medicines (privately-owned, based in Tokyo) received Orphan Drug Designation for odevixibat for the expected indication of Progressive Familial Intrahepatic Cholestasis, a rare disease affecting young children, from the Ministry of Health, Labour and Welfare (MHLW) of Japan. Read more here.

Revolka and Sumitomo Pharma Co. announced the successful completion of their collaborative drug discovery project for rare diseases with Revoka's design and identification of lead candidates using its aiProtein tech platform. Sumitomo Pharma will receive a right of first refusal to an exclusive license of the molecules and RevolKa will receive a milestone payment (financial details undisclosed). Read more here.

Takeda presented data from its Phase 3 clinical trial investigating HYQVIAwith Recombinant Human Hyaluronidase] as maintenance therapy for chronic inflammatory demyelinating polyneuropathy. Results showed a clinically significant reduction in relapse rate with HYQVIA vs placebo (9.7% versus 31.4%, respectively; p = 0.0045). Read more here.

South Korea?

SK bioscience received WHO Emergency Use Listing of its COVID-19 vaccine, SKYCovione, a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein. Read more here.?

Curocell announced updates from its Phase 2 clinical trial of anbal-cel at the International Conference on Malignant Lymphoma on June 15, including a durable complete response of 68% at 1 month, 61% at 3 months, and 60% at 6 months, respectively. Read more here.

SK pharmteco completed its second facility for Cell and Gene Therapies manufacturing in Europe, situated in the biotech cluster of Genopole in France. Read more here.

India

Sun Pharma's Canadian subsidiary, Sun Pharma Canada, received approval from Health Canada for WINLEVI, a 1% clascoterone cream, as a topical treatment for acne. Read more here.

Singapore

ASLAN Pharmaceuticals (Singapore) and Zenyaku Kogyo Co. (Japan) entered a strategic licensing agreement granting Zenyaku exclusive rights to develop and commercialize eblasakimab in atopic dermatitis (AD) and all other indications in Japan. ASLAN will receive an upfront payment of $12 million and may receive an additional $3 million in milestones. Zenyaku plans to initiate a Phase 1 study of eblasakimab in Japan in the first half of 2024. Read more here.?

AWAK Technologies and Singapore General Hospital launched a pre-pivotal clinical trial to study the safety and efficacy of the AWAK PD peritoneal dialysis system device that serves as transportable dialysis for patients with end-stage kidney disease. Read more here.

Zeta Surgical successfully treated the first patient in its first-in-human trial of Zeta Cranial Navigation System at Singapore's National Neuroscience Institute. Read more here.

HistoIndex announced it will present new data on its novel stain-free tissue imaging technology using clinically validated artificial intelligence (AI) algorithms at the EASL Congress, taking place June 21-24, 2023. Read more here.

Bangladesh

Dyadic International (Nasdaq: DYAI) entered into a Memorandum of Understanding with EDCL, the state-owned pharma company under the Ministry of Health and Family Welfare of Bangladesh, to facilitate biopharmaceutical research, pre-clinical development, cGMP production, clinical trials, regulatory and other relevant areas of interest in Bangladesh. Read more here.

Conferences

Click here to view our calendar of Upcoming Conferences.

Including:

June 23-26, 2023: The American Diabetes Association - Scientific Sessions will take place in San Diego, CA and in a virtual format. Register here.

June 24-27, 2023: The SNM - Society of Nuclear Medicine - Annual Meeting will take place in Chicago, IL. Register here.

June 24-28, 2023: The Research Society on Alcoholism - Annual Scientific Meeting will take place in Washington DC. Register here.

June 25-28, 2023: The TD Cowen 2nd Annual Tools/Dx Revolution will take place in Dana Point, CA. Register here.

June 25- 29, 2023: The Drug Information Association - Annual Meeting will take place in Boston, MA. Register here.

June 26, 2023: The H.C. Wainwright 1st Annual Neuropsychiatry Virtual Conference will take place in a virtual format. Register here.

June 26-28, 2023: UBS Healthcare Services Conference will take place in Cape Cod, MA. Register here.