On October 12, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, OCT 12, 2020, View Source [SID1234568301]).

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The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await the results from the ongoing randomized, phase 3 OCEAN study before submitting an application for marketing authorization. Upon completion, the outcome from the OCEAN study comparing melflufen and pomalidomide in patients with RRMM, will be submitted to regulatory authorities to potentially expand the label of melflufen.

The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD).

"Key opinion leaders and clinics across Europe have gained extensive experience of melflufen from our clinical development program in multiple myeloma. We share a mutual interest to enable early access to this rapidly growing patient population in desperate need of new treatment options", says Klaas Bakker, CMO of Oncopeptides.

According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if; the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.

The US Food and Drug Administration, FDA, has granted priority review to Oncopeptides´ New Drug Application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA has set a target date for the review of the New Drug Application, to February 28, 2021.

On October 11, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported the completion of the Share Subscription Agreement through which an affiliate of Pfizer Inc. ("Pfizer",NYSE: PFE) subscribed for newly issued CStone shares at approximately US$200 million (equivalent to approximately HK$1.55 billion), bringing into effect the multifaceted strategic collaboration that the companies announced on September 30, 2020 (Press release, CStone Pharmaceauticals, OCT 11, 2020, View Source [SID1234568284]).

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The Listing Committee of the Stock Exchange of Hong Kong approved the listing of 115,928,803 additional shares subscribed by Pfizer at a price of approximately HK$13.37 per share. The shares represent approximately 9.90 percent of the issued share capital of CStone as enlarged by the allotment and issue of the shares.

CStone entered into the share subscription as part of a strategic collaboration framework with Pfizer to advance its strategic, commercial and financial objectives as it transitions into a fully integrated biopharma company. Completion of the share subscription allows the companies to proceed with the initiatives envisioned as part of this framework:

CStone has agreed to grant Pfizer an exclusive license to commercialize sugemalimab, an anti-PD-L1 monoclonal antibody and one of CStone’s core late-stage assets, in mainland China
CStone and Pfizer will collaborate on the development and commercialization of additional oncology assets in the Greater China market
CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market

On October 10, 2020 Antengene Corporation, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, and WuXi Biologics ("WuXi Bio") (2269.HK) reported that they have signed a strategic cooperation Memorandum of Understanding (MoU) to co-operate in the development and production of novel drugs, and jointly promote the R&D of innovative oncology therapies (Press release, Antengene, OCT 10, 2020, View Source [SID1234568285]).

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China’s cancer incidence and mortality have been increasing in recent years. Low rates of survival and access to innovative therapies are persistent obstacles to local cancer treatment. With the vision of "Treating patients beyond borders", Antengene is committed to bringing novel mechanisms of action and cutting-edge anti-tumor therapies to patients in China, the rest of Asia Pacific and around the world. By leveraging outstanding R&D capability and applying a differentiated discovery and development strategy, Antengene has built a pipeline with 12 innovative clinical and preclinical products characterized by their high target selectivity and synergistic activity within the pipeline. Foundations have been built in oncology with the breadth of diseases in which the pipeline has shown activity also extending to viral infections, autoimmunity and other disease fields. As a leading global open-access biologics technology platform, Wuxi Biologics offers end-to-end solutions based on its sophisticated R&D system and technological platform to advance the process of promoting drug R&D from concept to commercial manufacturing. Through the collaboration, Antengene and WuXi Biologics will make full use of their extensive resources and professional capabilities to accelerate the research and development of first-in-class or best-in-class innovative cancer therapies and provide patients with high-quality and affordable treatment plans as soon as possible .

"We are very glad to launch a strategic cooperation with WuXi Biologics. This cooperation is a timely decision. WuXi Biologics has first-class biopharmaceutical capabilities and could empower us with advanced technology," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene, "At present, Antengene has carried out a comprehensive layout for the research and development of innovative cancer medicines, and continues to promote the science-oriented R&D of anti-tumor drugs such as small molecule drugs, monoclonal drugs and bispecific antibody drugs. We are looking forward to enhancing the quality of research and development and leveraging complementary strengths of both companies in order to ultimately benefit a wider range of cancer patients."

Dr. Chris Chen, CEO of WuXi Biologics, said: "We are pleased to establish a strategic cooperation with Antengene. Through our diversified and integrated biologics technology platform, WuXi Biologics will continue to empower Antengene to accelerate the R&D process of innovative oncology therapies. We look forward to working together to achieve a win-win situation based on our capabilities and advantages and make positive contribution to the health and wellness of patients in China and the world."

On October 9, 2020 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that following the Company’s name change from Oncology Venture A/S to Allarity Therapeutics A/S, the Company will be trading under its new short name ALLR from Monday, 12 October 2020 (Press release, Allarity Therapeutics, OCT 9, 2020, View Source [SID1234569150]). The share’s ISIN code, DK0060732477, will remain unchanged.

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Concurrently, the Company’s listed equity rights (warrants), TO 2, will change short name from OV TO 2 to ALLR TO 2. The ISIN code of this instrument, DK0061153657, will also remain unchanged.

On October 9, 2020 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary unaudited revenue for the third quarter of fiscal year 2020 (Press release, Biofrontera, OCT 9, 2020, View Source [SID1234568552]).

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The Biofrontera-Group generated total preliminary unaudited revenue of approximately EUR 20.8 to 21.0 million in the period from January 1st to September 30th, 2020. This corresponds to revenue growth of about 9% compared to the same period last year (EUR 19.1 million).

Thereof, total preliminary unaudited revenue for the third quarter amounted to between EUR 4.7 and 4.9 million, about 9% less than in Q3 2019 (EUR 5.2 million). Preliminary unaudited Q3 2020 revenues from pure product sales were between EUR 4.6 and 4.8 million, which corresponds to a 6% decline compared to EUR 5.0 million in Q3 2019.

In the traditionally weak third quarter due to seasonality, the Company generated between EUR 2.7 and 2.9 million from sales of Ameluz in the USA, compared to EUR 3.4 million (approx. -19%) in Q3 2019. Product sales from Xepi contributed about EUR 45 thousand, compared to EUR 0.1 million in the same reporting period in 2019.

In Germany, sales revenues in the third quarter increased by about 36% to between EUR 1.5 and 1.7 million. In the rest of Europe, the Company generated product sales of about EUR 0.4 million, compared to EUR 0.5 million (approx. -15%) in the same period last year.

Despite the economic and social impact of the corona pandemic, product sales in the German market increased significantly compared to the previous year. Revenues in the United States were negatively affected, where the crisis continues to have a much stronger impact on the market. As in previous years, however, the Company continues to see the fourth quarter as the key revenue driver for its growing business in all markets.