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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 332 drug applications between 24 April 2024 and 30 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 73 drug names.

2024/04/24 – 2024/04/30

Period
2024/04/24 to 2024/04/30, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
332
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
3

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

332filings, 101 of them generic

By application type

Application typeFilings
Supplement160
Generic101
New drug51
Import re-registration9
Import6
Unspecified5

By drug type

Drug typeFilings
Chemical drug214
TCM67
Therapeutic biologic43
Prophylactic biologic6
Biologic2

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets5223
2Minoxidil Liniment4252
3复方聚乙二醇电解质散(Ⅱ) · No verified English name324
4Pregabalin Oral Solution315
5Bupivacaine Hydrochloride Injection314
6Fluvoxamine Maleate Tablets220
7Alanyl Glutamine Injection214
8Lactulose Oral Solution2134
9Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
10Lansoprazole Enteric Capsules213

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Di Liu Pharmaceutical Co., Ltd. romanized24230
2Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized880
3Shenyang Xing Qi Yan Yao Co., Ltd. romanized810
4Beijing Foyou Pharma CO.,LTD535
5Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
6BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED440
7Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized441
8Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized444
9Henan Hua Feng Pharmaceutical Co., Ltd. romanized440
10Shaanxi Jun He Run Kang Pharma Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

97 this week

AcceptedDrugApplicants
2024/04/30Import · Class 1 ASP2138注射液 · No verified English nameJXSL2400083 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/04/30Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2401322 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2024/04/30Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2401319 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/04/30Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2401318 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 硫酸沙丁胺醇糖浆 · No verified English nameCYHS2401315 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401314 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Bilastine Oral SolutionCYHS2401313 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401312 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Pregabalin Oral SolutionCYHS2401311 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Epinephrine InjectionCYHS2401310 Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized
2024/04/30Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2401309 CISEN PHARMACEUTICAL CO., LTD.
2024/04/30Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401308 Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2401307 Shaanxi Li Cai Pharma Co., Ltd. romanized; Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2024/04/30Generic · Class 3 Azithromycin Eye DropsCYHL2400080 Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/30New drug · Class 1.1 清降和胃颗粒 · No verified English nameCXZL2400022 Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400282 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400281 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 注射用sacituzumab tirumotecan · No verified English nameCXSL2400280 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400279 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400278 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 PM8002注射液 · No verified English nameCXSL2400277 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/04/30New drug · Class 1 PM1009注射液 · No verified English nameCXSL2400276 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400275 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400274 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400273 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 1 SQ-22031滴眼液 · No verified English nameCXSL2400272 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2024/04/30New drug · Class 2.4 Lidocaine CataplasmsCXHS2400038 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2024/04/30New drug · Class 1 苹果酸司妥吉仑片 · No verified English nameCXHS2400037 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2024/04/30New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2400424 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2024/04/30New drug · Class 2.2 环孢素眼用凝胶 · No verified English nameCXHL2400423 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized

67 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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