On May 11, 2021 Shanghai Henlius Biotech, Inc reported the Company has entered into a license agreement with Suzhou NeuPharma Co., Ltd. (NeuPharma) in respect of a small-molecule inhibitor of BRAF V600E HLX208 (RX208) (Press release, NeuPharma, MAY 11, 2022, View Source [SID1234617726]). NeuPharma will grant Henlius an exclusive license to research, develop, produce, commercialize and sublicense the product in China (including Hong Kong, Macau and Taiwan regions). This collaboration is an important part of Henlius’ strategies to accelerate diversified innovation with a variety of drug targets and modalities to further enhance current pipeline.

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BRAF V600E inhibitors can be used in the treatment of colorectal cancer, melanoma, and certain rare diseases including Erdheim-Chester Disease (ECD). Studies have shown that BRAF V600E inhibitor in combination with anti-EGFR monoclonal antibody can effectively improve the survival and prognosis of patients with colorectal cancer. The licensed product has a proprietary new chemical structure different from other marketed BRAF inhibitors, and it exhibited excellent anti-tumor efficacy and safety in preclinical studies. This product is currently in Phase 1 clinical study, and early clinical data have also suggested preliminary efficacy and minimal side effects in patients with cancer. It has the potential to become the Best-in-Class BRAF V600E inhibitor, and may have a synergy with Henlius’ proprietary EGFR or PD-1 targeted antibodies to enhance a high-quality, innovative and differentiated product portfolio for the treatment of various cancer types.

Henlius has accumulated rich experiences in global clinical trials and product commercialization in the field of oncology over the years. Its clinical development platform strictly complies with GCP standards and has passed several GCP inspections by the NMPA and the European Medicines Agency. Henlius will accelerate the clinical development and commercialization of this licensed product to full speed, leveraging its therapeutic potential in multiple cancer types to develop innovative and effective therapies for the patients. Looking forward, Henlius will further strengthen the in-licensing and collaboration on external high-quality innovative assets, to expand and upgrade its product pipeline and bring more affordable therapies to patients around the world.

About BRAF V600E Mutation
BRAF protein is an important upstream regulator of the MAPK/ERK signaling pathway, and the V600E mutation of BRAF can activate the downstream MEK protein, which induces the proliferation and invasion of tumor cells. The V600E mutation frequently occurs in colorectal cancer, thyroid cancer, melanoma and other types of cancers, which often predicts poor prognosis. Among those cancers, colorectal cancer is the second most common cancer in China, with a 5-15% BRAF V600E mutation rate[1].

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On May 11, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA ("Eurofarma"), a leading Brazilian pharmaceutical company with considerable experience in introducing and marketing innovative medical products throughout Latin America, for the development, manufacturing and commercialization in 16 Latin American countries of Henlius’ independently developed HANLIKANG (rituximab biosimilar), HANQUYOU (trastuzumab biosimilar, trade name in Europe: Zercepac), and HANBEITAI (bevacizumab biosimilar) (Press release, Shanghai Henlius Biotech, MAY 11, 2022, View Source [SID1234614786]). This collaboration is not only an endorsement of Henlius’ product quality and operational strength, but also a continuation of the company’s goal of advancing its worldwide footprint, building momentum for the company’s evolution from biotechnology to biopharma.

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Under the agreement terms, Henlius will receive up to a total of $50.5 million, including a $4.5 million upfront payment. Meanwhile, Eurofarma will acquire exclusive rights to rituximab HANLIKANG in 12 countries, including Mexico, Guatemala and Panama, as well as trastuzumab HANQUYOU in 11 countries, including Mexico, Chile and Ecuador, and bevacizumab HANBEITAI in 15 countries, including Mexico, Argentina and Chile. In addition, Eurofarma will obtain semi-exclusive rights to the three products in Brazil.

Mr. Jason Zhu, President of Henlius, said, "We feel really honored to partner with Eurofarma. Henlius has always adhered to our intention to improve patients’ lives by timely providing them with quality and affordable protein therapeutics. Eurofarma has one of the largest sales teams in Latin America. Its robust business network and resources will effectively promote the commercialization of Henlius products in Latin America and the availability to patients. It is hoped that our three products can become effective treatment options for more patients in Latin American countries and light up their lives."

"We are extremely proud of this new partnership, which marks our more robust coverage in biosimilars and confirms our recent moves and work to provide Latin America with the greatest products of the world. We are putting together two of our main strategies to achieve our goals: expanding our presence regionally to increase the revenues from international operations and deploying new technology to the medicine, that definitely helps us become a reference in innovative matter", says Martha Penna, Vice President of Innovation at Eurofarma.

Bearing patients’ needs in mind, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as joining hands with partners in the value chain. HANQUYOU (trade name in Europe: Zercepac), the first Chinese mAb biosimilar approved in both Europe and China, and HANBEITAI are commercialized by the company’s in-house team in China market. At present, both 150mg and 60mg dosage forms of HANQUYOU have been included in China’s National Reimbursement Drug List (NRDL), benefiting over 50,000 patients to date. HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA). As of now, it has benefited more than 100,000 Chinese patients. Meanwhile, Henlius has aggressively pursued international commercialization of HANQUYOU and HANLIKANG. The company actively collaborated with global partners such as Accord Healthcare, Cipla, Mabxience, and the Jacobson Group to bring its HANQUYOU to patients in the United States, Canada, Europe, and other emerging markets, covering over 80 countries and regions worldwide. Zercepac is now available in around 20 European nations and regions, including the United Kingdom, Germany, Spain, France, Italy, Ireland, Hungary, and Switzerland. Moreover, the company has also reached a cooperation agreement with Colombian pharmaceutical company Farma de Colombia to promote the commercialization of HANLIKANG in Colombia, Peru, Ecuador and Venezuela. Including the cooperation with Eurofarma, Henlius’ products have reached 19 populous countries in Latin America, covering more than 90% of the Latin American population.

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On May 11, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported plans to transfer and spin-off its cannabinoid clinical development pipeline assets to a wholly-owned subsidiary, Acanna Therapeutics Inc. ("Acanna"), by way of dividend to Enveric shareholders (Press release, Enveric Biosciences, MAY 11, 2022, View Source [SID1234614276]). The spin-off transaction will be subject to various conditions, including Acanna meeting the qualifications for listing on The Nasdaq Stock Market, and if successful, would result in two standalone public companies.

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Dr. Joseph Tucker, CEO of Enveric Biosciences, commented, "In these challenging markets, the Board and Management team have spent considerable time evaluating the best way to create additional value for all stakeholders – patients, shareholders, and employees. We believe it would be in the best interest of our shareholders to spin-off 100% equity ownership of our cannabinoid clinical development pipeline. Upon completion of the proposed transaction, each resulting public company would be able to focus all its resources on the development of its respective pipeline assets, enabling, we anticipate, greater opportunity for product development success."

Acanna has secured an initial $1MM from an investor in a Series A Convertible Preferred Stock and Warrant financing. Under the terms of the investment, Acanna will, subject to certain other conditions, receive an additional $4MM upon completion of the spin-off into an independent, separately traded public company listed on The Nasdaq Stock Market. Following the spin-off and the investment of an aggregate of $5MM, that investor is expected to hold 25% of Acanna and warrants to acquire additional shares. Palladium Capital Group acted as a financial advisor to Enveric. Please see the Current Report on Form 8-K filed by Enveric on May 11, 2022, for further details.

Dr. Tucker continued, "For Enveric and Acanna, this spin-off transaction would allow each company to commit 100% of its efforts and capabilities towards developing its respective drug candidate portfolio. For Enveric, going forward, we intend to focus on mental health. We believe that Enveric’s achievements in the last year, including preparations for a clinical trial, positive preclinical data, and ongoing expansion of our drug candidate portfolio, the Psybrary, position us well for the future."

Strategic Rationale for Spinoff
The Company believes that spinning off the cannabinoid assets will allow Enveric and Acanna to maximize long-term value for all stakeholders. Following the proposed transaction, both Enveric and Acanna intend to:

Have separate, focused management teams with the knowledge and skills to deploy appropriate strategies and meet the unique requirements for each company’s operations.
Allocate capital more efficiently and strategically to develop their respective assets further.
Provide unique investment characteristics of interest to the capital markets.