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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 225 drug applications between 22 June 2023 and 28 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 36 drug names.

2023/06/22 – 2023/06/28

Period
2023/06/22 to 2023/06/28, 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
225
Drugs with new generic filings (by drug name, de-duplicated)
36
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

225filings, 46 of them generic

By application type

Application typeFilings
Supplement111
Generic46
New drug46
Import re-registration11
Import6
Unspecified5

By drug type

Drug typeFilings
Chemical drug160
TCM37
Therapeutic biologic25
Prophylactic biologic2
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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops3216
2Tadalafil Tablets2123
3Carbazochrome Sodium Sulfonate Injection211
4Perampanel Tablets212
5Cytarabine for Injection212
6Lenvatinib Mesilate Capsules214
7Phenylephrine Hydrochloride Injection215
8Rocuronium Bromide Injection211
9阿伐替尼片 · No verified English name210
10二甲双胍恩格列净片(Ⅵ) · No verified English name110

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

132 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. romanized720
4Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
5Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized550
6Guangxi Jin Kang Pharma Co., Ltd. romanized530
7Boehringer Ingelheim International GmbH510
8Novartis Pharma Schweiz AG420
9Dr. Reddy's Laboratories Ltd.410
10Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized410

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

61 this week

AcceptedDrugApplicants
2023/06/28Import · Class 1 巴托利单抗注射液 · No verified English nameJXSS2300049 DRAGON MERIT HOLDINGS LIMITED; Samsung Biologics Co. Ltd.; Nuo Na Bio (Suzhou) Co., Ltd. romanized
2023/06/28Generic · Class 3 Pamidronate Disodium InjectionCYHS2301722 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/06/28Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2301711 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/06/28Generic · Class 3 Hydrotalcite SuspensionCYHS2301710 Tai Kang Hai En Pharma Co., Ltd. romanized
2023/06/28New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2300012 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized
2023/06/28New drug · Class 1 EI-001注射液 · No verified English nameCXSL2300440 An Li Xi Rong (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/28New drug · Class 1 DXC1002 · No verified English nameCXSL2300439 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2023/06/28New drug · Class 3.3 四价流感病毒亚单位疫苗 · No verified English nameCXSL2300438 Zhong Yi An Ke Bio Technology Co., Ltd. romanized
2023/06/28New drug · Class 2.2 HZ021口溶膜 · No verified English nameCXHL2300711 Jiangsu He Chen Pharma Co., Ltd. romanized
2023/06/28New drug · Class 2.4 青蒿琥酯片 · No verified English nameCXHL2300710 Gui Lin Nan Yao Co., Ltd. romanized; Shanghai Jiao Tong University romanized
2023/06/28New drug · Class 1 MI131外用溶液 · No verified English nameCXHL2300709 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/28New drug · Class 1 MI131外用溶液 · No verified English nameCXHL2300708 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/28New drug · Class 1 MI131外用溶液 · No verified English nameCXHL2300707 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2023/06/28New drug · Class 1 MAX-001胶囊 · No verified English nameCXHL2300706 An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/06/28New drug · Class 1 MAX-001胶囊 · No verified English nameCXHL2300705 An Yan Da Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2023/06/28New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300704 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/28New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2300703 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/28New drug · Class 1 TUL01101片 · No verified English nameCXHL2300702 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2023/06/28New drug · Class 1 TUL01101片 · No verified English nameCXHL2300701 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
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

31 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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