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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 388 drug applications between 10 May 2024 and 16 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 73 drug names.

2024/05/10 – 2024/05/16

Period
2024/05/10 to 2024/05/16, 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
388
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

388filings, 101 of them generic

By application type

Application typeFilings
Supplement158
Generic101
New drug89
Import22
Import re-registration11
Unspecified4
Drug-device combination product3

By drug type

Drug typeFilings
Chemical drug281
Therapeutic biologic57
TCM41
Prophylactic biologic6
Drug-device combination3

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
1Vonoprazan Fumarate Tablets3260
2Sacubitril Valsartan Sodium Tablets3270
3Benidipine Hydrochloride Tablets324
4Fluvoxamine Maleate Tablets320
5Sildenafil Citrate Tablets3112
6Nicorandil for Injection311
7Famotidine Injection228
8Phenylephrine Hydrochloride Injection225
9聚乙二醇钠钾散 · No verified English name223
10Tacrolimus Sustained-release Capsules216

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

219 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
3Janssen Research & Development LLC730
4Yi Chang Ren Fu Pharma Co., Ltd. romanized720
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620
7Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized610
8Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized545
9Hainan Huluwa Pharmaceutical Group Co., Ltd.535
10Pfizer Inc.520

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

138 this week

AcceptedDrugApplicants
2024/05/16Generic · Class 3 Montelukast Sodium Orally Disintegrating TabletsCYHL2400097 Beijing Bai Ao Pharma Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/05/16Generic · Class 3 Montelukast Sodium Orally Disintegrating TabletsCYHL2400096 Beijing Bai Ao Pharma Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2024/05/16New drug · Class 1 VPD/FC01001 注射液 · No verified English nameCXSL2400323 Wei Neng Sheng Ming Technology Group Co., Ltd. romanized
2024/05/16New drug · Class 1 IASO-782注射液 · No verified English nameCXSL2400322 Shanghai Xun Lu Bio Technology Co., Ltd. romanized
2024/05/16New drug · Class 1 CPU-216片 · No verified English nameCXHL2400497 Zhongguo Yao Ke University romanized; Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized
2024/05/16New drug · Class 1 CS060304片 · No verified English nameCXHL2400496 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/05/16New drug · Class 1 CS060304片 · No verified English nameCXHL2400495 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/05/16New drug · Class 1 CS060304片 · No verified English nameCXHL2400494 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/05/16New drug · Class 1 CS060304片 · No verified English nameCXHL2400493 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/05/16New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2400492 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2024/05/15Import · Class 2.2 艾加莫德α注射液(皮下注射) · No verified English nameJXSS2400042 argenx BV; Patheon Italia S. p. A.; Zai Lab (Shanghai) Co. Ltd.
2024/05/15Import · Class 1 PF-06823859注射液 · No verified English nameJXSL2400092 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/05/15New drug · Class 1 注射用BA1302 · No verified English nameCXSL2400321 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/05/15New drug · Class 1 RC148注射液 · No verified English nameCXSL2400320 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/15New drug · Class 1 FS-8002注射液 · No verified English nameCXSL2400319 Hua Pu Bio Technology (Hebei) Co., Ltd. romanized; Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Fu Sheng Kang (Shanghai) Bio Technology Co., Ltd. romanized
2024/05/15New drug · Class 1 注射用RC88 · No verified English nameCXSL2400318 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/15New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2400317 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/05/15New drug · Class 2.2 BCM347口溶膜 · No verified English nameCXHS2400043 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2024/05/15New drug · Class 2.2 BCM347口溶膜 · No verified English nameCXHS2400042 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
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.

108 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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