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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 462 drug applications between 8 May 2024 and 14 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 139, covering 103 drug names.

2024/05/08 – 2024/05/14

Period
2024/05/08 to 2024/05/14, 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
462
Drugs with new generic filings (by drug name, de-duplicated)
103
Accepted this week, now under review
2

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

462filings, 139 of them generic

By application type

Application typeFilings
Supplement177
Generic139
New drug101
Import27
Import re-registration13
Unspecified5

By drug type

Drug typeFilings
Chemical drug334
Therapeutic biologic63
TCM61
Prophylactic biologic4

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

103 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Sacubitril Valsartan Sodium Tablets3270
3Benidipine Hydrochloride Tablets324
4Fluvoxamine Maleate Tablets320
5Telmisartan Tablets314
6Sildenafil Citrate Tablets3112
7Deutetrabenazine Tablets310
8Nicorandil for Injection311
9Famotidine Injection228
10Phenylephrine Hydrochloride Injection225

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

264 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized19170
2Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized1020
3Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized767
4Janssen Research & Development LLC730
5Yi Chang Ren Fu Pharma Co., Ltd. romanized720
6Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized721
7Hubei Di Liu Pharmaceutical Co., Ltd. romanized640
8Bai Ao Tai Biopharmaceutical Co., Ltd. romanized630
9Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.623
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620

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

170 this week

AcceptedDrugApplicants
2024/05/14Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2400041 AstraZeneca AB; Name not romanized
2024/05/14Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2401460 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2024/05/14Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401459 Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2024/05/14Generic · Class 3 Famotidine InjectionCYHS2401455 Hainan Wei Jian Pharma Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/05/14Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2401452 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2024/05/14Generic · Class 3 Desonide CreamCYHS2401451 Hainan Quan Ying Pharma Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized
2024/05/14Generic · Class 3 Cycloserine CapsulesCYHS2401450 Hebei Long Hai Pharma Co., Ltd. romanized
2024/05/14Generic · Class 3 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2401447 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/14Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401444 Chongqing Xi Er An Pharma Co., Ltd. romanized
2024/05/14Generic · Class 3 Arformoterol Tartrate Inhalation SolutionCYHL2400094 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/05/14Generic · Class 3 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400093 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/05/14New drug · Class 1 SCT650C 注射液 · No verified English nameCXSL2400316 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2024/05/14New drug · Class 1 WGc-043 注射液 · No verified English nameCXSL2400315 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 1 WGc-043 注射液 · No verified English nameCXSL2400314 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 1 IBI3003 · No verified English nameCXSL2400313 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/14New drug · Class 1 注射用YK012 · No verified English nameCXSL2400312 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2024/05/14New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400311 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/05/14New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400310 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/05/14New drug · Class 1 注射用RFUS-250 · No verified English nameCXHL2400491 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/14New drug · Class 1 注射用RFUS-250 · No verified English nameCXHL2400490 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/14New drug · Class 1 HSK39004吸入混悬液 · No verified English nameCXHL2400489 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/05/14New drug · Class 1 HSK39004吸入混悬液 · No verified English nameCXHL2400488 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/05/14New drug · Class 2.2 利拉鲁肽注射液 · No verified English nameCXHL2400487 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 2.1 HDM3010 · No verified English nameCXHL2400486 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/05/14New drug · Class 1 HTMC0658片 · No verified English nameCXHL2400485 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/05/14New drug · Class 1 HTMC0658片 · No verified English nameCXHL2400484 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/05/14New drug · Class 1 ABSK043胶囊 · No verified English nameCXHL2400483 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2400482 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2400481 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/14New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2400480 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized

140 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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