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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 206 drug applications between 21 June 2023 and 27 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.

2023/06/21 – 2023/06/27

Period
2023/06/21 to 2023/06/27, 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
206
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

206filings, 44 of them generic

By application type

Application typeFilings
Supplement92
Generic44
New drug44
Import12
Import re-registration10
Unspecified4

By drug type

Drug typeFilings
Chemical drug150
TCM29
Therapeutic biologic25
Biologic1
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
1Levofloxacin Eye Drops3216
2Carbazochrome Sodium Sulfonate Injection211
3Perampanel Tablets212
4Carfilzomib For Injection210
5Phenylephrine Hydrochloride Injection215
6Nalbuphine Hydrochloride Injection2111
7Rocuronium Bromide Injection211
8阿伐替尼片 · No verified English name210
9Acetylcysteine Injection1153
10Lactulose Oral Solution1134

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

128 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shi Qi Pharmaceutical (Guangdong) Co., Ltd. romanized12100
2Hainan Brilliant Pharmaceutical Co., Ltd.733
3Hainan Ai Ke Pharmaceutical Co., Ltd. romanized620
4Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
5Dr. Reddy's Laboratories Ltd.410
6Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized410
7Jiangsu Vanguard Pharmaceutical Co., Ltd.323
8AbbVie Inc.310
9Organon Pharma (UK) Limited310
10Guangxi Jin Kang Pharma Co., Ltd. romanized310

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

65 this week

AcceptedDrugApplicants
2023/06/27Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2300115 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/06/27Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2301702 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/27Generic · Class 3 Lamivudine and Tenofovir Disoproxil Fumarate TabletsCYHS2301701 Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized
2023/06/27Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2301697 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/06/27Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2301696 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/06/27New drug · Class 1 AHT-101注射液 · No verified English nameCXSL2300437 Guangxi Lu Gang Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/27New drug · Class 1 LQ036单域抗体吸入用粉末 · No verified English nameCXSL2300435 Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/27New drug · Class 1 AK131注射液 · No verified English nameCXSL2300434 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/06/27New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2300433 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2023/06/27New drug · Class 1 注射用SHR-3032 · No verified English nameCXSL2300432 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/27New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300431 Beijing Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Hua Nuo Tai Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/06/27New drug · Class 1 UBT251注射液 · No verified English nameCXHL2300700 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/06/27New drug · Class 1 UBT251注射液 · No verified English nameCXHL2300699 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/06/27New drug · Class 1 VS-H101注射液 · No verified English nameCXHL2300698 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2023/06/27New drug · Class 1 TYK-00540片 · No verified English nameCXHL2300695 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/06/27New drug · Class 1 TYK-00540片 · No verified English nameCXHL2300694 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2023/06/26Import · Class 1 RO7565020注射液 · No verified English nameJXSL2300114 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2023/06/26Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301684 Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/06/26Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2301683 Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2023/06/26Generic · Class 3 Vancomycin Hydrochloride CapsulesCYHS2301681 Shi Sen Hai (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized
2023/06/26New drug · Class 1.1 小儿佛芍和中颗粒 · No verified English nameCXZL2300044 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/06/26New drug · Class 1 CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300430 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/06/26New drug · Class 1 CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2300429 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2023/06/26New drug · Class 1 MK-1084片 · No verified English nameCXHL2300693 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/06/26New drug · Class 1 MK-1084片 · No verified English nameCXHL2300692 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/06/26New drug · Class 2.2; 2.4 醋酸阿比特龙片(Ⅰ) · No verified English nameCXHL2300691 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/06/26New drug · Class 1 AC-201片 · No verified English nameCXHL2300690 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/06/26New drug · Class 1 AC-201片 · No verified English nameCXHL2300689 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/06/26New drug · Class 1 LIT-00814片 · No verified English nameCXHL2300688 Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/26New drug · Class 1 LIT-00814片 · No verified English nameCXHL2300687 Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized

35 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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