YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 299 drug applications between 26 January 2023 and 1 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 59 drug names.

2023/01/26 – 2023/02/01

Period
2023/01/26 to 2023/02/01, 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
299
Drugs with new generic filings (by drug name, de-duplicated)
59
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

299filings, 72 of them generic

By application type

Application typeFilings
Supplement132
Generic72
New drug64
Import re-registration18
Import13

By drug type

Drug typeFilings
Chemical drug240
Therapeutic biologic29
TCM26
Prophylactic biologic4

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Doxofylline Injection225
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
3Famotidine Injection228
4Avatrombopag Maleate Tablets220
5Acetylcysteine Granules214
6Voriconazole Tablets211
7Carbazochrome Sodium Sulfonate Injection211
8Olaparib Tablets210
9Levocarnitine Injection214
10Levofloxacin and Sodium Chloride Injection2114

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized810
2Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized770
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD730
4Ping Guang Pharmaceutical Co., Ltd. romanized660
5Bracco Imaging Italia s.r.l.610
6Hunan Ke Lun Pharmaceutical Co., Ltd. romanized543
7Sichuan Kelun Pharmaceutical Co., Ltd.530
8Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized520
9Guangzhou Bai Te Qiao Guang Medical Yong Pin Co., Ltd. romanized510
10Qilu Pharmaceutical Co., Ltd.431

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

99 this week

AcceptedDrugApplicants
2023/02/01Import · Class 1 格罗菲妥单抗注射液 · No verified English nameJXSS2300014 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2023/02/01Import · Class 1 SAR408701注射液 · No verified English nameJXSL2300029 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/02/01Import · Class 2.2 Efgartigimod注射液 · No verified English nameJXSL2300028 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2023/02/01Generic · Class 3 Etoposide InjectionCYHS2300284 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/02/01Generic · Class 3 Minoxidil Topical SolutionCYHS2300278 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/02/01Generic · Class 3 Minoxidil Topical SolutionCYHS2300277 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2023/02/01Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2300273 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2023/02/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300270 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/02/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300269 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/02/01Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300012 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized
2023/02/01New drug · Class 1.2 人参总次苷片 · No verified English nameCXZL2300006 Shanghai Hui Yu Biopharmaceuticals Technology Co., Ltd. romanized
2023/02/01New drug · Class 1 CAStem细胞注射液 · No verified English nameCXSL2300072 Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized
2023/02/01New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2300071 Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized
2023/02/01New drug · Class 1 烟曲霉点刺液 · No verified English nameCXSL2300070 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2023/02/01New drug · Class 1 ZT002注射液 · No verified English nameCXSL2300069 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/02/01New drug · Class 1 SHR8058滴眼液 · No verified English nameCXHS2300021 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/02/01New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2300150 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/02/01New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2300149 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/02/01New drug · Class 1 QLH12002片 · No verified English nameCXHL2300148 Qilu Pharmaceutical Co., Ltd.
2023/02/01New drug · Class 1 QLH12002片 · No verified English nameCXHL2300147 Qilu Pharmaceutical Co., Ltd.
2023/02/01New drug · Class 2.2 西甲硅油口溶膜 · No verified English nameCXHL2300146 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2023/02/01New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2300145 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/02/01New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2300144 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/02/01New drug · Class 1 W1302片 · No verified English nameCXHL2300143 Zhongguo Yi Xue Ke College Drug Research Institute romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/02/01New drug · Class 1 CT-3505胶囊 · No verified English nameCXHL2300142 Shou Yao Holding (Beijing) Co., Ltd. romanized
2023/01/31Import · Class 1 AZD7789 · No verified English nameJXSL2300027 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/31Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2300026 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2023/01/31Import · Class 1 LOU064片 · No verified English nameJXHL2300016 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/01/31Import · Class 1 LOU064片 · No verified English nameJXHL2300015 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/01/31Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300267 Liaoning Da Xiong Pharmaceutical Co., Ltd. romanized

69 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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