YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 421 drug applications between 6 December 2023 and 12 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 67 drug names.

2023/12/06 – 2023/12/12

Period
2023/12/06 to 2023/12/12, 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
421
Drugs with new generic filings (by drug name, de-duplicated)
67
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

421filings, 96 of them generic

By application type

Application typeFilings
Supplement219
Generic96
New drug67
Import24
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug258
TCM87
Therapeutic biologic66
Biologic6
Prophylactic 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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Morinidazole and Sodium Chloride Injection339
2地氯雷他定口服溶液 · No verified English name3326
3Levocarnitine Oral Solution329
4Minoxidil Liniment3252
5阿普米司特片 · No verified English name313
6Diprophylline Injection227
7Ceftazidime And Avibactam Sodium For Injection2212
8Methocarbamol Injection223
9Agomelatine Tablets228
10Folic acid 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

230 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized43340
2Novo Nordisk A/S1010
3Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized880
4Fresenius Kabi Austria GmbH610
5ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.543
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
7Karuna Therapeutics Inc.510
8GlaxoSmithKline (Ireland) Limited430
9Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized434
10Zhejiang Nord Pharmaceutical Co., Ltd433

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

128 this week

AcceptedDrugApplicants
2023/12/12Import · Class 3.1 艾沙妥昔单抗注射液 · No verified English nameJXSS2300091 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2023/12/12Import · Class 3.1 艾沙妥昔单抗注射液 · No verified English nameJXSS2300090 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd.
2023/12/12Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2300089 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2023/12/12Generic · Class 3 注射用头孢唑林钠/氯化钠注射液 · No verified English nameCYHS2303443 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2303442 Guangdong Gao Shang Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Hui Xuan Pharmaceuticals Technology Co., Ltd. romanized
2023/12/12Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2303441 Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/12Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2303440 Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/12/12Generic · Class 3 Adenosine InjectionCYHS2303438 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Adenosine InjectionCYHS2303437 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303435 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/12/12Generic · Class 3 Calcium Gluconate InjectionCYHS2303434 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/12/12Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303428 Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2023/12/12New drug · Class 3.1 当归补血颗粒 · No verified English nameCXZS2300025 Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized
2023/12/12New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2300096 Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2300095 Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSS2300094 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/12/12New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2300853 Guangdong Rui Shun Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 1.2 重组三价脊髓灰质炎疫苗(Sf-RVN细胞) · No verified English nameCXSL2300852 Kang Xi Nuo Bio Shareholding Company romanized
2023/12/12New drug · Class 1 Taletrectinib胶囊 · No verified English nameCXHL2301379 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2023/12/12New drug · Class 1 FCN-338片 · No verified English nameCXHL2301378 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/12/12New drug · Class 1 ADC189颗粒 · No verified English nameCXHL2301377 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 1 FCN-338片 · No verified English nameCXHL2301376 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2023/12/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301375 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/12/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301374 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/12/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301373 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/12/12New drug · Class 1 FCN-647片 · No verified English nameCXHL2301372 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2023/12/12New drug · Class 1 BIOT-001片 · No verified English nameCXHL2301371 Xiamen Bao Tai Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 1 BIOT-001片 · No verified English nameCXHL2301370 Xiamen Bao Tai Bio Technology Co., Ltd. romanized
2023/12/12New drug · Class 1 BIOT-001片 · No verified English nameCXHL2301369 Xiamen Bao Tai Bio Technology Co., Ltd. romanized
2023/12/10New drug · Class 1 YZJ-5799磷酸盐胶囊 · No verified English nameCXHL2301368 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized

98 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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