YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 312 drug applications between 15 December 2023 and 21 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 65 drug names.

2023/12/15 – 2023/12/21

Period
2023/12/15 to 2023/12/21, 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
312
Drugs with new generic filings (by drug name, de-duplicated)
65
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

312filings, 81 of them generic

By application type

Application typeFilings
Supplement143
Generic81
New drug56
Import17
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug221
TCM56
Therapeutic biologic31
Biologic3
In vitro diagnostic reagent1

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
1Lactulose Oral Solution4334
2Sacubitril Valsartan Sodium Tablets3270
3Cetitizine Hydrochloride Oral Solution326
4Potassium Chloride Granules224
5Brimonidine Tartrate Eye Drops224
6Progesterone Sustained-release Vaginal Gel222
7Carboplatin Injection2110
8Diquafosol Sodium Eye Drops215
9复方醋酸钠林格注射液 · No verified English name212
10Nicorandil for Injection211

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized13130
2Novartis Pharma Schweiz AG740
3Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized620
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
5Hainan Xu Wo Pharma Co., Ltd. romanized440
6Qi Lu An Ti Pharmaceutical Co., Ltd. romanized440
7AstraZeneca AB430
8Shandong Xin Shi Dai Pharma Co., Ltd. romanized434
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized420
10Chengdu Brilliant Pharmaceutical Co., Ltd.420

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
2023/12/21Import · Class 1 JNJ-80948543注射液 · No verified English nameJXSL2300231 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/12/21Import · Class 1 JNJ-80948543注射液 · No verified English nameJXSL2300230 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/12/21Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303555 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/12/21Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2303554 Zhejiang Ju Tai Pharma Co., Ltd. romanized
2023/12/21Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2303552 Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2023/12/21New drug · Class 1 SG301注射液 · No verified English nameCXSL2300874 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2023/12/21New drug · Class 3.4 注射用替妥木单抗 · No verified English nameCXSL2300873 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2023/12/21New drug · Class 1 NM6606片 · No verified English nameCXHL2301425 Teng Ji (Xiamen) Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/21New drug · Class 1 NM6606片 · No verified English nameCXHL2301424 Teng Ji (Xiamen) Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/21New drug · Class 1 TGRX-1942片 · No verified English nameCXHL2301423 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2023/12/21New drug · Class 1 TGRX-1942片 · No verified English nameCXHL2301422 Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized
2023/12/20Import · Class 1 A24110He注射液 · No verified English nameJXHL2300318 Lipigon Pharmaceuticals AB; Leaderna Therapeutics Ltd
2023/12/20Import · Class 1 Zibotentan达格列净片 · No verified English nameJXHL2300317 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/20Import · Class 1 Zibotentan达格列净片 · No verified English nameJXHL2300316 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/20Generic · Class 3 Pentoxifylline InjectionCYHS2303537 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/12/20Generic · Class 3 注射用比阿培南/氯化钠注射液 · No verified English nameCYHS2303536 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/20Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303534 Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2023/12/20New drug · Class 1.1 芪参颗粒 · No verified English nameCXZL2300074 Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized
2023/12/20New drug · Class 1 K1注射液 · No verified English nameCXSL2300872 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/12/20New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300871 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301421 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301420 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301419 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.3 LH-2103胶囊 · No verified English nameCXHL2301418 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/12/19Import · Class 2.4 琥珀酸瑞波西利片 · No verified English nameJXHS2300126 Novartis Pharma Schweiz AG; Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.; Beijing Novartis Pharma Co. Ltd.
2023/12/19Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2303523 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2023/12/19Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303519 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303518 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2303511 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/12/19Generic · Class 3 Isoniazid InjectionCYHS2303510 Guangzhou Lv Shi Zi Pharmaceutical 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.