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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 134 drug applications between 2 May 2024 and 8 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.

2024/05/02 – 2024/05/08

Period
2024/05/02 to 2024/05/08, 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
134
Drugs with new generic filings (by drug name, de-duplicated)
35
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

134filings, 44 of them generic

By application type

Application typeFilings
Supplement61
Generic44
New drug12
Import9
Import re-registration6
Unspecified2

By drug type

Drug typeFilings
Chemical drug97
TCM19
Therapeutic biologic17
Prophylactic 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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Telmisartan Tablets314
2Lactulose Oral Solution2134
3Perampanel Tablets212
4Procaterol Hydrochloride Solution for Inhalation212
5头孢地尼干混悬剂 · No verified English name212
6Cytarabine for Injection212
7Dabigatran Etexilate Capsules212
8Avanafil Tablets212
9中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English name110
10Nintedanib Esilate Soft Capsules116

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

98 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized550
2Chongqing Sai Wei Pharma Co., Ltd. romanized510
3Takeda Pharmaceuticals International AG Ireland Branch420
4Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.310
5Hebei Shan Mu Shi Pharma Co., Ltd. romanized313
6Anhui Jin Ma Pharma Co., Ltd. romanized220
7Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized220
8Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized220
9Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized222
10Rui Yang Pharmaceutical Co., Ltd. romanized222

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

39 this week

AcceptedDrugApplicants
2024/05/08Import · Class 1 DS-7300a · No verified English nameJXSL2400087 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD
2024/05/08Import · Class 2.2 Ropeginterferon alfa-2b (P1101) 注射液 · No verified English nameJXSL2400086 PharmaEssentia Corporation; PharmaEssentia Biotechnology(Beijing)Company limited
2024/05/08Import · Class 1 Relatlimab注射液 · No verified English nameJXSL2400085 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/05/08Import · Class 1 BI 1810631 片 · No verified English nameJXHL2400099 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2024/05/08Generic · Class 3 Lidocaine CataplasmsCYHS2401368 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/08Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2401361 Fujian Xin Di Pharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/08Generic · Class 3 Cimetidine InjectionCYHS2401360 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/05/08Generic · Class 3 盐酸洛美沙星滴眼液 · No verified English nameCYHS2401352 Jiangsu Guang Cheng Pharma Co., Ltd. romanized
2024/05/08Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401351 Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/05/08Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2401349 Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized
2024/05/08Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2401348 Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized
2024/05/08Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2401340 Sui Cheng Pharma Co., Ltd. romanized
2024/05/08Generic · Class 3 Colistimethate Sodium for InjectionCYHL2400083 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/05/08New drug · Class 1 HBM9027注射液 · No verified English nameCXSL2400289 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/05/08New drug · Class 1 AFN0328注射液 · No verified English nameCXSL2400288 Hefei A Fa Na Bio Technology Co., Ltd. romanized; Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized; Hefei A Fa Na An Ke Bio Technology Co., Ltd. romanized
2024/05/08New drug · Class 1 NTQ3617片 · No verified English nameCXHL2400432 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/05/08New drug · Class 1 NTQ3617片 · No verified English nameCXHL2400431 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/05/08New drug · Class 1 NTQ3617片 · No verified English nameCXHL2400430 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/05/08New drug · Class 1 SJP-0132滴眼液 · No verified English nameCXHL2400429 Qian Shou Pharmaceutical Technology (Beijing) Co., Ltd. romanized
2024/05/08New drug · Class 1 HP560片 · No verified English nameCXHL2400428 Hai Chuang Pharma Co., Ltd. romanized
2024/05/08New drug · Class 1 HP560片 · No verified English nameCXHL2400427 Hai Chuang Pharma Co., Ltd. romanized
2024/05/07Import · Class 1 Fitusiran注射液 · No verified English nameJXHS2400034 Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd.
2024/05/07Import · Class 1 Fitusiran注射液 · No verified English nameJXHS2400033 Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd.
2024/05/07Import · Class 1 RO7434656注射液 · No verified English nameJXHL2400098 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/05/07Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2400097 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/05/07Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2400096 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/05/07Generic · Class 3 Minoxidil LinimentCYHS2401338 Xian De Li Bio Chemical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401337 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401336 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/07Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2401335 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized

9 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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