YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 346 drug applications between 25 August 2023 and 31 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 65 drug names.

2023/08/25 – 2023/08/31

Period
2023/08/25 to 2023/08/31, 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
346
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
1

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

346filings, 83 of them generic

By application type

Application typeFilings
Supplement188
Generic83
New drug50
Import14
Unspecified8
Import re-registration3

By drug type

Drug typeFilings
Chemical drug238
TCM67
Therapeutic biologic34
Prophylactic biologic6
Biologic1

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4223
2Nicorandil for Injection321
3Lidocaine and Prilocaine Cream2224
4腺苷钴胺胶囊 · No verified English name228
5Tacrolimus Ointment216
6Enzalutamide Tablets212
7Potassium Chloride Injection2110
8Risperidone powder and solvent for depot suspension for Injection210
9Pemetrexed Disodium for Injection214
10注射用头孢唑肟钠 · No verified English name214

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

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32280
2Guizhou Rui He Pharmaceutical Co., Ltd. romanized23230
3AstraZeneca AB730
4Novartis Europharm Limited630
5Celgene Corporation610
6Sanofi Winthrop Industrie610
7Sanofi-Aventis Deutschland GmbH550
8Qilu Pharmaceutical Co., Ltd.520
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
10Shaanxi Kang Na Duo Pharma Co., Ltd. romanized330

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

96 this week

AcceptedDrugApplicants
2023/08/31Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2300074 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/08/31Import · Class 3.1 比奇珠单抗注射液 · No verified English nameJXSS2300073 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/08/31Generic · Class 3 Enzalutamide TabletsCYHS2302339 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/08/31Generic · Class 3 Enzalutamide TabletsCYHS2302338 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/08/31Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2302337 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Zhejiang Qian Yuan Hai Li Sheng Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 Epalrestat TabletsCYHS2302333 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2023/08/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302332 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302331 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2023/08/31Generic · Class 3 Potassium Chloride GranulesCYHS2302326 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/08/31Generic · Class 3 Nicorandil for InjectionCYHS2302325 Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/08/31Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2302323 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2023/08/31New drug · Class 1.1 麻星宣肺止咳贴 · No verified English nameCXZL2300056 Hubei You Er Sheng Pharma Co., Ltd. romanized
2023/08/31New drug · Class 1.1 麻星宣肺止咳贴 · No verified English nameCXZL2300055 Hubei You Er Sheng Pharma Co., Ltd. romanized
2023/08/31New drug · Class 1 注射用重组溶瘤病毒M1 · No verified English nameCXSL2300588 Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized
2023/08/31New drug · Class 1 SRSD101注射液 · No verified English nameCXHL2300932 Jing Yin Pharma (Shanghai) Co., Ltd. romanized
2023/08/31New drug · Class 1 OQL036 · No verified English nameCXHL2300931 Shanghai An Kuo Pharmaceuticals Technology Co., Ltd. romanized
2023/08/31New drug · Class 1 OQL036 · No verified English nameCXHL2300930 Shanghai An Kuo Pharmaceuticals Technology Co., Ltd. romanized
2023/08/31New drug · Class 1 ASK120067片 · No verified English nameCXHL2300929 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2023/08/31New drug · Class 2.4 康替唑胺片 · No verified English nameCXHL2300928 Shanghai Meng Ke Pharma Co., Ltd. romanized
2023/08/31New drug · Class 1 注射用MRX-4 · No verified English nameCXHL2300927 Shanghai Meng Ke Pharma Co., Ltd. romanized
2023/08/30Import · Class 1 PF-06940434注射液 · No verified English nameJXSL2300159 Pfizer Inc.; Pfizer Investment CO. Ltd.
2023/08/30Generic · Class 3 盐酸丙卡特罗片 · No verified English nameCYHS2302320 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2023/08/30Generic · Class 3 Pentoxifylline InjectionCYHS2302319 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2302310 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/08/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302308 Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2302307 Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Mesalamine extended release capsulesCYHS2302305 Beijing Foyou Pharma CO.,LTD
2023/08/30Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302304 Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
2023/08/30Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2302302 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/30Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2302299 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized

66 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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