On September 29, 2022 YishengBio Co., Ltd. (to be renamed as YS Biopharma Co., Ltd., and herein referred to as "YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, and Summit Healthcare Acquisition Corp. (Nasdaq: SMIH) ("Summit"), a publicly traded special purpose acquisition company, reported that they have entered into a definitive agreement for a business combination of Summit and the Company (the "Transaction") (Press release, Yisheng Biopharma, SEP 29, 2022, View Source [SID1234621582]). Upon closing of the Transaction, the combined company will be renamed as YS Biopharma Co., Ltd. and become a publicly traded company on the Nasdaq.

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YS Biopharma’s YSJATM rabies vaccine is one of the leading products in the human use rabies vaccine market in China with a total product sales of approximately RMB503 million in the fiscal year ended March 31, 2022. Supported by strong sales & marketing infrastructure, over 90 million doses of YSJATM rabies vaccine have been administered with excellent protection efficacy and safety for post-exposure protection against rabies.

YS Biopharma has also developed a broad pipeline powered by its proprietary PIKA immunomodulating technology platform, including four clinical stage candidates, targeting a wide range of clinical indications with significant market potential, such as rabies, COVID-19, hepatitis B, cancer, shingles and influenza.

Over the years, YS Biopharma has made significant advancements in commercialization expertise and manufacturing infrastructure. It has completed the construction of three state-of-art manufacturing plants for YSJATM rabies vaccine, PIKA adjuvanted rabies vaccine and PIKA adjuvanted recombinant COVID-19 vaccine.

Upon closing of the Transaction, YS Biopharma will continue to be led by Mr. Yi Zhang, its founder and chairman, Dr. Hui Shao, its president and chief executive officer, and the current management team. YS Biopharma has over 800 employees with business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines.

Mr. Yi Zhang, the founder and chairman of YS Biopharma, commented, "YS Biopharma has always been the trailblazer and at the forefront in developing new technology and products for vaccine and immunological therapeutics. This transaction will fuel our strategy for future business expansion and execution and allow shareholders to participate in significant upside potential created by the partnership with Summit."

Dr. Hui Shao, the president and the chief executive officer of YS Biopharma, stated, "Today’s announcement on strategic combination between YS Biopharma and Summit represents a major milestone in our journey to become a global leader in transformative vaccine and therapeutic biologics arena. We anticipate the closing of the business and financial transactions will further accelerate the commercialization endeavor of our promising pipeline in many countries and create shareholder values for both YS Biopharma and Summit."

Mr. Bo Tan, the chief executive officer, co-chief investment officer and director of Summit, stated, "Summit is missioned to identify high-quality growth companies in global healthcare industry. YS Biopharma is clearly a differentiated vaccine platform with growing revenue and robust pipelines. With sponsor’s firm commitment, support from our shareholders and Forward Purchase Investors and further enhanced by a bonus share structure in the transaction, we believe YS Biopharma will be well positioned to achieve the next series of milestones and the business combination will create meaningful value for our shareholders."

YS Biopharma Investment Highlights

A global commercialization-stage biopharmaceutical company focusing on innovative vaccines and therapeutic biologics with over 800 employees and business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines
A leading human use rabies vaccine manufacturing company in China, with approximately RMB503 million product sales in the fiscal year ended March 31, 2022, over 1,700 local Centers for Disease Control and Prevention sales coverage, as well as over 90 million doses administered with excellent safety and efficacy profile for post-exposure protection against rabies
An in-house developed and proprietary PIKA immunomodulating technology platform in immunological and therapeutic innovation, having established strong intellectual franchise evidenced by over 70 patents granted by over 30 jurisdictions covering both technology and product innovations
PIKA adjuvanted rabies vaccine candidate is expected to enter into a multi-center Phase III clinical trials in Singapore, the Philippines, Vietnam and Pakistan in the fourth quarter of 2022, with the potential to become "best in class," and cited as a novel vaccine with dose reduction and accelerated regimen by the Background Paper of World Health Organization (WHO)
PIKA recombinant COVID-19 vaccine in Phase II/III clinical development in the United Arab Emirates, the Philippines and Pakistan with potentially differentiated immunological profile as compared to mRNA-based vaccines, including two-year sustainable immune response, cellular immuno response, broad neutralization against all the prevalent COVID-19 virus mutants such as Omicron variants, and additional therapeutic treatment benefits
Established track record, technical expertise and infrastructure in mass production of vaccine and biologics, providing strong execution support in clinical development and commercialization objectives
Transaction Overview

The pre-money equity value of YS Biopharma in the proposed Transaction is approximately $834 million. YS Biopharma shareholders will become the majority owners immediately after the closing of the Transaction. The business combination is expected to provide up to approximately $230 million in gross proceeds to YS Biopharma, including $30 million from Forward Purchase Investors and up to approximately $200 million currently held in Summit’s trust account, assuming no redemption from Summit’s existing public shareholders. Proceeds from the Transaction will allow YS Biopharma to fund its ongoing and planned clinical trials, future commercial launch of PIKA adjuvanted rabies vaccine, the construction of new GMP-compliant manufacturing plants as well as developing other product candidates.

Each of the board of directors of YS Biopharma and Summit has unanimously approved the proposed Transaction. The shareholders of YS Biopharma have also approved the proposed Transaction at its extraordinary general shareholders meeting. Completion of the proposed Transaction is still subject to the approval of Summit’s shareholders and certain other customary closing conditions, including, among others, a registration statement on Form F-4 (the "Registration Statement"), of which the proxy statement/prospectus forms a part, being declared effective by the U.S. Securities and Exchange Commission (the "SEC"), and the approval by the Nasdaq Stock Market LLC on the listing application of the combined company. The Transaction is targeted to be completed in the first quarter of 2023.

Additional information about the proposed Transaction, including copies of the business combination agreement and related agreements, will be provided in a Current Report on Form 8-K to be filed by Summit with the SEC and available at www.sec.gov. YS Biopharma intends to file the Registration Statement, which will contain a proxy statement and a prospectus, with the SEC in connection with the Transaction.

Advisors

Wilson Sonsini Goodrich & Rosati, Jingtian & Gongcheng and Maples and Calder (Hong Kong) LLP are serving as legal advisors to YS Biopharma in connection with the Transaction.

Cooley LLP and Ogier are serving as legal advisors to Summit in connection with the Transaction.

Investor Presentation

An investor presentation with more detailed information regarding the proposed Transaction will be filed by Summit as an exhibit to a Current Report on Form 8-K, which can be viewed on the SEC’s website at www.sec.gov.

On September 29, 2022 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported that the results from a phase Ib study of pruxelutamide (used to be called proxalutamide, GT0918) for the treatment of patients with androgen receptor positive (AR+) metastatic breast cancer (AR+ mBC) in China have been published in the international journal, European Journal of Cancer (2021 Impact Factor: 10.002, EJC) on September 28, 2022, further demonstrating the efficacy and safety of pruxelutamide in patients with AR+ mBC (Press release, Suzhou Kintor Pharmaceuticals, SEP 29, 2022, View Source [SID1234621572]).

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Highlights

Pruxelutamide showed promising activity in heavily pretreated AR+ mBC patients.
Pruxelutamide showed an acceptable safety profile in heavily pretreated AR+ mBC.
Recommended phase II dose of pruxelutamide was defined as 200mg orally once daily.
AR expression, cell-free DNA yield, CNV might be associated with response.
Patients with PIK3CA pathogenic mutation showed longer progression-free survival.
Metastatic breast cancer (mBC) remains a largely incurable disease in most patients, resulting in approximately 0.5 million deaths every year worldwide. At present, the primary goals of mBC therapy are to prolong patient survival and maintain their quality of life. Any novel therapy likely to provide a survival advantage in patients is valuable.

Pruxelutamide is an oral, newly-generation AR antagonist, developed by Kintor Pharma. Results from this study of pruxelutamide were published in a paper titled "Proxalutamide in patients with AR-positive metastatic breast cancer: Results from an open-label multicentre phase Ib study and biomarker analysis". This phase Ib study was designed to evaluate the preliminary efficacy and safety of pruxelutamide monotherapy in patients with pretreated AR+ mBC and to determine the RP2D of pruxelutamide. The corresponding author of the paper, Professor Huiping Li of Peking University Cancer Hospital & Institute, was the principal investigator of the phase I clinical trial in China.

In this open-label, dose-expansion, multicentre phase Ib trial, patients with AR+ mBC (immunohistochemistry [IHC] AR≥1%) received pruxelutamide orally once daily. Two pruxelutamide dose cohorts (cohort A: 200mg; cohort B: 300mg) were sequentially investigated. Primary endpoints were disease control rate (DCR) at 8 and 16 weeks and recommended phase II dose (RP2D).

Finally, 45 eligible patients were enrolled and treated. 30 eligible patients were enrolled in cohort A (200mg orally once daily) from April 19, 2018, to March 7, 2019. 15 patients were enrolled into cohort B (300mg orally once daily) from March 11, 2019, to April 16, 2019.

Among 39 evaluable patients, DCR at 8 and 16 weeks was 25.6% (95% confidence interval [CI], 11.9–39.4%), with 26.9% in cohort A and 23.1% in cohort B. The 6-month progression-free survival (PFS) rate was 19.6% (95% CI, 10.2–37.5%). In the triple-negative subgroup, DCR at 8 weeks was 38.5%, with median PFS of 9.1 months (95% CI, 7.8–NA) in those who achieved response at 8 weeks (n = 5).

All 45 patients were evaluable for safety. Overall, pruxelutamide demonstrated a good safety profile. The most common grade 3 or 4 AEs were AST increase (8.9%) and γ-glutamyltransferase increase (8.9%). No treatment-related deaths or dose reductions occurred in either cohort.

This study conducted another exploratory analysis to identify potential predictive biomarkers of treatment response. By biomarker analysis, patients with moderate AR expression of IHC (26%–75%), PIK3CA pathogenic mutations, or <60 ng/ml cell-free DNA yield showed longer PFS.

In conclusion, pruxelutamide demonstrated promising anti-tumour activity with an acceptable safety profile in patients with heavily pretreated AR+ mBC, particularly in the TNBC subgroup. And, this study determined the RP2D to be 200mg orally once daily. Furthermore, we identified that AR expression, CNVs, and cfDNA yield may be associated with the response to pruxelutamide, highlighting the importance of conducting genomic profiling in patients with AR+ mBC to identify those likely to benefit from pruxelutamide treatment. The data supports further clinical development of pruxelutamide on treating breast cancer patients.

On September 29, 2022 Kling Biotherapeutics, BV, (Kling Bio) a clinical stage biotechnology company focused on developing novel antibody-based therapeutics for cancer and infectious diseases generated through its proprietary discovery platform, reported the dosing of the first patient with KBA1412 in its Phase 1b trial (KBA1412-101, NCT05501821), an open-label, multi-center study evaluating the safety, tolerability, PK/PD, and potential efficacy of KBA1412 in adult patients with advanced solid tumors not responding to standard of care (Press release, Kling Biotherapeutics, SEP 29, 2022, View Source [SID1234621571]).

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KBA1412 is a first in class fully human anti-CD9 antibody based on an antibody produced by circulating B cells in the blood of a cancer survivor. "KBA1412 has remarkable properties identified in preclinical studies including efficacy as monotherapy mediated by two anti-cancer mechanisms (cell-mediated cytotoxicity and enhanced immune cell infiltration into tumors), synergy with PD-1 blockade, and a very favorable preclinical safety profile not seen previously with anti-CD9 antibodies" said Timothy M. Wright, MD, Kling Bio co-founder and interim CEO.

The Phase 1b study will involve dose escalation followed by several expansion cohorts in patients with selected solid tumor types. The expansion cohorts will study KBA1412 alone and in combination with a PD-1 checkpoint inhibitor to further define the dose for future Phase 2 studies and to evaluate secondary endpoints for preliminary assessment of clinical efficacy. "This study marks an important milestone for Kling Bio and demonstrates the potential to leverage the ‘human-to-human’ approach from discovery to clinical development for advancing novel cancer treatments," said Sohail Ahmed, MD, MBA, Chief Medical Officer at Kling Bio.

On September 29, 2022 Oxilio, a pioneering drug development company repurposing existing drugs to address unmet needs in cancer treatment, and Quotient Sciences, a drug development and manufacturing accelerator, reported an update on the development of Oxilio’s OXL001 product (Press release, Oxilio, SEP 29, 2022, View Source [SID1234621570]).

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Oxilio is pleased to announce that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its first Clinical Trial Application (CTA) with OXL001.

Following initial formulation development by Oxilio in collaboration with its partner company, TRx Biosciences, Quotient Sciences’ integrated Translational Pharmaceutics platform has been used to carry out the technical transfer and scale-up activities associated with this program and will continue to be used to support clinical trial material manufacturing and the investigation of the pharmacokinetics and safety of OXL001 in healthy volunteers.

Mark Egerton, PhD, CEO of Quotient Sciences, said: "We are delighted to be able to continue to assist Oxilio with their OXL001 program. By leveraging our unique, integrated Translational Pharmaceutics platform, Oxilio will have the flexibility to adjust doses based on emerging clinical data within their study, enabling us to improve their likelihood of success, reduce their development time, and ultimately get new medicines to patients faster."

Dr Simon Yaxley, Director of Oxilio, added: "Utilizing Quotient Sciences Translational Pharmaceutics platform has enabled us to successfully achieve this important milestone of receiving regulatory approval to undertake our first Phase 1 clinical trial with OXL001. We look forward to commencing this study within the next few weeks."

On September 29, 2022 Haleon plc ("Haleon") (LSE: HLN, NYSE: HLN) reported the commencement of offers to exchange seven series of outstanding unregistered notes issued by GSK Consumer Healthcare Capital US LLC (the "US Issuer") and GSK Consumer Healthcare Capital UK plc (the "UK Issuer", and together with the US Issuer, the "Issuers") (as set out below), as previously disclosed in Haleon’s public filings and pursuant to a registration rights agreement entered into at the time of the original issuance of the notes (Press release, Haleon Group, SEP 29, 2022, View Source [SID1234621569]).

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Upon the terms and subject to the conditions set forth in the prospectus and the accompanying letter of transmittal, Haleon is offering to exchange in seven concurrent, but separate, offers (the "Exchange Offers") any and all of the seven series of notes identified under "Title of Series of Original Notes" in the table below (collectively, the "Original Notes"), for a like principal amount of notes of the same series that have been registered under the Securities Act of 1933, as amended (the "Securities Act"), as described under "Title of Series of Exchange Notes" in the table below (collectively, the "Exchange Notes"). The terms of each series of Exchange Notes are substantially identical to the terms of the corresponding Original Notes of such series, except that the transfer restrictions, the special mandatory redemption provisions and registration rights applicable to the Original Notes do not apply to the Exchange Notes. The sole purpose of the Exchange Offers is to offer the holders of the Original Notes the opportunity to receive Exchange Notes that have been registered under the Securities Act and are expected to be listed on the New York Stock Exchange.

The Exchange Offers will expire at 5:00 p.m. (Eastern time) on October 28, 2022, unless extended or earlier terminated by Haleon (such date and time, as the same may be extended or earlier terminated with respect to any or all series of Exchange Notes (as defined below), the "Expiration Date"). In order to be exchanged, an Original Note must be validly tendered and not validly withdrawn at or prior to the applicable Expiration Date, and accepted by the relevant Issuer and Haleon. The "Settlement Date" with respect to the Exchange Offers will be promptly following the Expiration Date and is expected to be November 2, 2022.

A Registration Statement on Form F-4 (the "Registration Statement") relating to the issuance of the Exchange Notes was filed with the Securities and Exchange Commission ("SEC") today but has not yet been declared effective. The Exchange Offers are being made pursuant to the terms and conditions set forth in the preliminary prospectus, dated as of September 29, 2022 (the "Prospectus"), which forms a part of the Registration Statement.

Global Bondholder Services Corporation will act as Exchange Agent for the Exchange Offers. Questions or requests for assistance related to the Exchange Offers or for additional copies of the Prospectus may be directed to Global Bondholder Services Corporation at (855) 654-2014. You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Exchange Offers.

If Haleon terminates any Exchange Offer with respect to one or more series of Original Notes, it will give prompt notice to the Exchange Agent, and all Original Notes tendered pursuant to such terminated Exchange Offer will be returned promptly to the tendering holders thereof. With effect from such termination, any Original Notes blocked in DTC will be released.

Notes issued by the US Issuer

Description of the Original Notes

Description of the Exchange Notes

CUSIP Number

Title of Series of Original Notes

CUSIP
Number

Title of Series of Exchange Notes

36264F AA9 /
U04020 AA8

3.024% Callable Fixed Rate Senior Notes due 2024

36264F AH4

3.024% Callable Fixed Rate Senior Notes due 2024

36264G AB5 /
U0396G AB9

Callable Floating Rate Senior Notes due 2024

36264F AJ0

Callable Floating Rate Senior Notes due 2024

36264F AB7/
U04020 AB6

3.375% Fixed Rate Senior Notes due 2027

36264F AK7

3.375% Fixed Rate Senior Notes due 2027

36264F AC5 /
U04020 AC4

3.375% Fixed Rate Senior Notes due 2029

36264F AL5

3.375% Fixed Rate Senior Notes due 2029

36264F AD3 /
U04020 AD2

3.625% Fixed Rate Senior Notes due 2032

36264F AM3

3.625% Fixed Rate Senior Notes due 2032

36264F AE1 /
U04020 AE0

4.000% Fixed Rate Senior Notes due 2052

36264F AN1

4.000% Fixed Rate Senior Notes due 2052

Notes issued by the UK Issuer

Description of the Original Notes

Description of the Exchange Notes

CUSIP Number

Title of Series of Original Notes

CUSIP
Number

Title of Series of Exchange Notes

36264N AA2 /
G4164D AA6

3.125% Fixed Rate Senior Notes due 2025

36264N AB0

3.125% Fixed Rate Senior Notes due 2025

Holders are advised to check with any bank, securities broker or other intermediary through which they hold Original Notes as to when such intermediary needs to receive instructions from a holder in order for that holder to be able to participate in, or (in the circumstances in which revocation is permitted) revoke their instruction to participate in, the Exchange Offers before the deadlines specified herein and in the documents pertaining to the Exchange Offers. The deadlines set by each clearing system for the submission and withdrawal of exchange instructions will also be earlier than the relevant deadlines specified herein and in the documents pertaining to the Exchange Offers.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (the "EEA"). For these purposes, a "retail investor" means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive (EU) 2014/65 (as amended, "MiFID II") or (ii) a customer within the meaning of Directive (EU) 2016/97(as amended, the "Insurance Distribution Directive"), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the "PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling of the New Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.

Any offer of the New Notes in any member state of the EEA will be made pursuant to an exemption under Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the Prospectus Regulation.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the United Kingdom (the "UK"). For these purposes, a "retail investor" means a person who is one (or more) of the following: (i) a retail client, as defined in point (8) of Article 2 of Regulation (EU) No 2017/565 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "EUWA"); or (ii) a customer within the meaning of the provisions of the Financial Services and Markets Act 2000 (as amended, the "FSMA") and any rules or regulations made under the FSMA to implement the Insurance Distribution Directive, where that customer would not qualify as a professional client, as defined in point (8) of Article 2(1) of Regulation (EU) No 600/2014 as it forms part of UK domestic law by virtue of the EUWA. Consequently, no key information document required by Regulation (EU) No. 1286/2014 as it forms part of UK domestic law by virtue of the EUWA (as amended, the "UK PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the UK has been prepared and therefore offering or selling the New Notes or otherwise making them available to any retail investor in the UK may be unlawful under the UK PRIIPs Regulation.

Any offer of the New Notes in the UK will be made pursuant to an exemption under Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of EUWA (the "UK Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the UK Prospectus Regulation.

In the United Kingdom, this press release is being distributed only to, and is directed only at (i) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the "Order"), and/or (ii) high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together referred to as "relevant persons"). This press release must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this press release relates is only available to, and will be engaged in with, relevant persons only.