Our JourneyOur breakthroughs, from company formation to FDA approval
Our breakthroughs include being awarded BioNexus status and achieving a first for Malaysia: approval of SKF™ as a New Dietary Ingredient (NDIN) by the USFDA.
Obtained FDA Clearance
- SKF7™ achieved a first for Malaysia when it was cleared by the USFDA as a New Dietary Ingredient (NDIN). SKF7™ has been successfully registered in:
- • Singapore, as a traditional medicine
- • Indonesia, as a dietary supplement
- • United States, as a dietary supplement
- In progress:
- • Canada, as a natural health product
- • European Union (EU) and United Kingdom, as a herbal medicine product
- • Australia and New Zealand, as a complementary medicine
- • China, as a dietary supplement
- • South Korea, as a health functional food; and
- • United Arab Emirates (UAE) and Saudi Arabia, as a dietary supplement
Approval of Phase 2 Randomized Clinical Trials
- We received approvals from three regulatory bodies in Malaysia, Indonesia and India to conduct the “Dose-Ranging Study Of Labisia pumila Aqueous Ethanolic Standardized Extract (SKF7™) For Obesity: A Randomized, Double-Blind, Placebo-Controlled, Phase-2 Study”.
- Submitted the SKF7™ dossier to the United States Food and Drug Administration (USFDA) for clearance as New Dietary Ingredient.
- Submitted the SKF7™ dossier to the European Food Safety Authority (EFSA) for clearance as Novel Food.
Acquired Labeesity® IPR and Trademark
- We secured the Commercialisation of R&D Fund (CRDF) from the Malaysian Technology Development Corporation (MTDC) to acquire the Trademark and IPR for Labeesity® from Universiti Sains Malaysia (USM).
- We secured funding from the Ministry of International Trade and Industry (MITI) of Malaysia to conduct R&D on the effects of SKF7™ on diabetes and cancer by Universiti Kebangsaan Malaysia (UKM) and Universiti Putra Malaysia (UPM).
- We were one of the top companies at the Nutrition Capital Network Investor Meeting at SupplySideWest, held in Las Vegas, United States. We were also in the top 10 companies at Leaders in Innovation Accelerator (LIA Malaysia).
Approval of Labeesity® by NPRA
- Labeesity® which contains SKF7™, the Standardised bio-extract of Labisia pumila, was approved by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) as a traditional medicine, and launched in October. Read more about Labeesity®
Pre-Clinical Works Continues
- Selected as part of BioNext program, a partnership between SME Corp and Bioeconomy Corporation Biotech that identifies and assists local biotech companies with the potential for global success. Preclinical works continued towards regulatory approval and optimising lab scale findings to commercial scale.
Appointed as Anchor Company by the Ministry of Agriculture and Food Industry
- We were appointed as an Anchor Company by the Ministry of Agriculture and Food Industry (MAFI) under the National Key Economy Area, Entry Point Project 1, High Value Herbal Products Program to conduct pre-clinical and clinical research on Labisia pumila as an anti-obesity botanical drug. This was a continuation from the R&D by Prof Zhari Ismail et al, Universiti Sains Malaysia (USM).
Labisia pumila for Anti-obesity
- A study funded by the National Research Grant Scheme (NRGS) led by Prof Zhari Ismail from Universiti Sains Malaysia (USM), was published, proving the benefits of Labisia pumila and highlighting its efficacy as an anti-obesity treatment. We began discussions with the Ministry of Agriculture and Food Industry (MAFI) of Malaysia on the commercialization of these findings.
- We began expanding our research into the study of the medicinal value of local plants and herbs such as Orthosiphon stamineus (Misai Kucing), and Labisia pumila (Kacip Fatimah). This was our first introduction to biopharmaceuticals and botanical drugs development and commercialization. See our product pipeline here.
Appointed as Program Partner
- We were appointed as a Program Partner of the Northern Corridor Implementation Authority (NCIA), whose objective was to accelerate economic growth in the northern region of Peninsular Malaysia. Under this program, our scope expanded to include plant genomics, DNA fingerprinting, and product development.
Assembled Research Team
- We assembled a team of leading researchers from multiple Malaysian public universities across various expert domains to study plant and herb pharmacology; the first collaboration of its kind. View the full leadership and advisory team here.
Expanded into Horticulture
- We expanded our R&D and commercialization of products and services to include food crops and herbal medicine.
Established Tissue Culture Lab and Nursery
- We established a tissue culture laboratory and plant nursery. This was our first step in building our proprietary end-to-end tissue culture technology and plant germplasms.
- The Malaysian Biotechnology Corporation (now known as the Bioeconomy Corporation) awarded Orchid Life with BioNexus status and seed funding to expand the commercialization of tissue culture technology from Universiti Putera Malaysia (UPM).
Awarded Our First Grant from MTDC
- Under the Technology Garage Fund scheme, the Malaysian Technology Development Corporation (MTDC) gave us our first break by helping us commercialize tissue culture technology for propagating orchids, based on research by Universiti Putra Malaysia (UPM).
Founded Orchid Life Sdn Bhd
- Orchid Life Sdn Bhd was established on 1 December 2006. Our founders Abdul Razak Mohd Isa and Mustadza Muhamad had intended for Orchid Life to be an agribiotechnology company focusing on horticulture and floriculture products and services.
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