I. Industry Risk Analysis

(1) Policy Risk

Currently, the policy risks in the oral contraceptive industry are concentrated in the implementation and evaluation stages. At the policy implementation level, regulatory authorities are tightening control over drug advertisements, online sales channels, and prescription management. Entrepreneurs are facing the pressure of reconstructing the compliance of marketing models. During the policy evaluation period, ethical disputes over reproductive health products may trigger a dynamic adjustment mechanism, posing a risk of tightened access qualifications for the in – hospital market. The medical insurance cost – control policy continues to compress the reimbursement scope of OTC drugs, directly affecting the stability of the terminal pricing system. International drug regulatory standards are forcing domestic policies to iterate rapidly. Enterprises need to continuously invest funds to cope with the upgrade of the registration and approval process, and their cash flow is under pressure in the short term.

(2) Economic Risk

The economic risks currently faced by the oral contraceptive industry are concentrated in the fluctuations on the demand side and the squeeze on the cost side. In an economic downturn, consumers reduce their medical expenditures, and the consumption priority of non – essential drugs decreases, directly impacting market demand. At the same time, the capital winter has made it difficult for the biopharmaceutical industry to raise funds. Coupled with the rising prices of raw materials and the profit – margin compression by the centralized procurement policy, start – up enterprises are facing the dual pressures of difficult recovery of R & D investment and price competition. The long – term demand uncertainty brought about by the intensification of population aging and the adjustment of the fertility policy further amplifies the cyclical fluctuation risks of the industry.

(3) Social Risk

Significant generational consumption differences are exacerbating the industry’s difficulties. Generation Z and the millennial group have a more open attitude towards the concept of health management, but the continuously low fertility rate weakens the core demand scenario. The Generation X, with strong traditional contraceptive concepts, still holds social discourse power, and there is a risk of moral disputes in the public opinion field. Young people are more sensitive to the side effects of drugs and prefer non – drug contraceptive methods, while the medical needs of the elderly population have not been effectively transformed. The generational cultural gap has led to an increase in the cost of health education. Entrepreneurs need to deal with the suppression of sex education by conservative forces and meet the picky demands of Generation Z for the technological attributes of products.

(4) Legal Risk

The oral contraceptive industry faces multiple legal risks. Strict drug approval requirements may extend the product launch cycle and increase compliance costs. The production process must comply with GMP standards, and non – compliant products will face penalties or even recall risks. Sales and promotions are restricted by advertising laws, and improper statements can easily lead to false advertising lawsuits. The collection and storage of patients’ privacy data must comply with the provisions of the Personal Information Protection Law, and information leakage may result in high – value fines. Patent infringement disputes occur frequently, and generic drug enterprises are prone to face intellectual property lawsuits from original research pharmaceutical companies. After the implementation of the Consumer Rights Protection Law, insufficient side – effect warnings or improper handling of after – sales disputes may trigger compensation risks. Policy adjustments in some regions may suddenly raise the industry access threshold, leading to the invalidation of previous investments.

II. Entrepreneurship Guide

(1) Suggestions on Entrepreneurial Opportunities

Entrepreneurs should focus on the non – prescription (OTC) oral contraceptive market segment, develop new short – acting contraceptives suitable for the physical constitution of Chinese women, and combine private e – commerce channels to build a closed – loop service of “online consultation + direct drug delivery” to strengthen consumer education and reduce selection anxiety. For the sinking market, basic and universal products can be designed, while in first – and second – tier cities, mid – to high – end product lines with vitamin compound formulas can be promoted. At the same time, a hardware linkage scenario of smart pill boxes + menstrual cycle management apps can be set up, and a subscription – based membership service can be explored to improve the repurchase rate.

(2) Suggestions on Entrepreneurial Resources

Entrepreneurs in the oral contraceptive industry should focus on the integration of core resources. They should first obtain compliance qualifications and support from drug regulatory policies, and cooperate with CRO institutions with clinical trial experience to accelerate product registration. They should bind high – quality raw material suppliers and pharmaceutical enterprises with GMP certification to ensure the supply chain, and reduce the initial production capacity investment through the ODM model. They should layout both online and offline channels, connect to mature e – commerce platforms and chain pharmacy terminals, and use private domain traffic tools to accurately reach young female users. They should form a composite team covering medicine, pharmacy, and Internet marketing, and introduce authoritative consultants in the field of reproductive health to enhance professional endorsement. They should expand financing channels with government health industry funds or investment institutions in the medical sector, and apply for innovative drug support policies for differentiated product lines (such as natural – ingredient contraceptives). At the same time, they should establish a user privacy data protection system and strengthen ethical compliance construction to avoid public opinion risks.

(3) Suggestions on Entrepreneurial Teams

Entrepreneurs in the oral contraceptive industry should form a composite team with expertise in pharmaceutical R & D, clinical medicine, regulatory affairs, and insights into the female health market. The core members should include at least one professional with drug registration and application experience to handle the strict approval processes in different countries, and operational talents familiar with gynecological medical channels should be introduced to quickly build trust among doctors. The team should have legal advisors to specifically handle ethical reviews of contraceptive drugs and patent layout, and market personnel with experience in Internet health products should be recruited to accurately reach young female users. A flat decision – making mechanism should be adopted to ensure that the product iteration speed is in sync with policy and regulatory changes.

(4) Suggestions on Entrepreneurial Risks

Entrepreneurs should first ensure product compliance, strictly follow the approval process of OTC drugs by the National Medical Products Administration, complete bioequivalence tests and safety data filing in advance, and avoid project failures due to lack of qualifications. A dual – backup mechanism for the supply chain should be established, with a focus on monitoring the supply stability of pharmaceutical raw materials (such as the purity of progestin), and priority supply agreements should be signed with at least two raw material factories that have passed GMP certification. To address the risk of user privacy, a privacy computing module should be embedded in the intelligent consultation system to ensure that health data is “usable but invisible”. In terms of marketing, an AI review system should be preset to automatically filter absolute terms prohibited by the Measures for the Review of Drug Advertisements, and “regional compliance packages” for advertisement review and filing in different provinces and cities should be prepared in advance. It is recommended to reserve 20% of the funds to cope with sudden policy adjustments, such as the expansion of volume – based procurement or changes in the policy of converting prescription drugs to OTC drugs.