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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 5 October 2023 and 11 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 62 drug names.

2023/10/05 – 2023/10/11

Period
2023/10/05 to 2023/10/11, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
0

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

347filings, 80 of them generic

By application type

Application typeFilings
Supplement160
Generic80
New drug65
Import17
Import re-registration15
Unspecified9
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug250
Therapeutic biologic51
TCM40
Prophylactic biologic6

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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Edoxaban Tosilate Tablets629
2Minoxidil Liniment3252
3Phenylephrine Hydrochloride Injection225
4Clindamycin Phosphate Topical Solution211
5Lacosamide Tablets210
6昂丹司琼口溶膜 · No verified English name212
7Sacubitril Valsartan Sodium Tablets2170
8注射用头孢唑肟钠 · No verified English name214
9Sodium Hyaluronate Eye Drops2130
10Dapoxetine Hydrochloride Tablets2120

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD1451
2Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized990
3Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized650
4Jiangsu En Hua Pharma Co., Ltd. romanized620
5Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized535
6Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized510
7AstraZeneca AB440
8Janssen-Cilag SpA420
9Sichuan Kelun Pharmaceutical Co., Ltd.422
10CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.421

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

106 this week

AcceptedDrugApplicants
2023/10/11Import · Class 1 Lebrikizumab注射液 · No verified English nameJXSL2300178 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/10/11Import · Class 1 AMG 509 · No verified English nameJXSL2300177 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/10/11Import · Class 1 VAY736注射液 · No verified English nameJXSL2300176 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/10/11Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2300248 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2023/10/11Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2300247 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2023/10/11Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2302689 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/10/11Generic · Class 3 Minoxidil LinimentCYHS2302688 Chongqing Yi Ling Qi Lu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/10/11Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2302686 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/10/11Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2302685 Henan Run Hong Pharmaceutical Co., Ltd. romanized
2023/10/11Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2302683 TC Pharmaceuticals (Jiangsu) Co., Ltd
2023/10/11Generic · Class 3 Meloxicam injectionCYHL2300128 Qilu Pharmaceutical Co., Ltd.
2023/10/11New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2300685 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2300684 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2300683 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 1 TQB2618注射液 · No verified English nameCXSL2300682 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 1 LTC004 · No verified English nameCXSL2300681 Beijing Zhi Dao Bio Technology Co., Ltd. romanized
2023/10/11New drug · Class 1 IM83嵌合抗原受体T细胞注射液(IM83 CAR-T细胞注射液) · No verified English nameCXSL2300680 Beijing Yi Miao Medical Technology Co., Ltd. romanized
2023/10/11New drug · Class 1 吡罗西尼片 · No verified English nameCXHS2300093 Xuan Zhu Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2023/10/11New drug · Class 2.2; 2.4 盐酸右美托咪定滴鼻液 · No verified English nameCXHL2301083 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/10/11New drug · Class 2.2; 2.4 盐酸右美托咪定滴鼻液 · No verified English nameCXHL2301082 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/10/11New drug · Class 2.2; 2.4 盐酸右美托咪定滴鼻液 · No verified English nameCXHL2301081 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/10/11New drug · Class 2.2; 2.4 盐酸右美托咪定滴鼻液 · No verified English nameCXHL2301080 Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/10/11New drug · Class 2.2 桉柠蒎软胶囊 · No verified English nameCXHL2301079 Beijing Yuan Da Jiu He Pharma Co., Ltd. romanized
2023/10/11New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2301078 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/10/11New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2301077 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/10/11New drug · Class 1 LPM6690176胶囊 · No verified English nameCXHL2301076 Yan Tai Chuang He Bio Technology Co., Ltd. romanized
2023/10/11New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301075 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301074 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301073 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/10/11New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301072 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

76 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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