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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 395 drug applications between 17 February 2023 and 23 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 65 drug names.

2023/02/17 – 2023/02/23

Period
2023/02/17 to 2023/02/23, 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
395
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
1

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

395filings, 94 of them generic

By application type

Application typeFilings
Supplement219
Generic94
New drug39
Import23
Import re-registration16
Unspecified4

By drug type

Drug typeFilings
Chemical drug290
TCM58
Therapeutic biologic39
Prophylactic biologic8

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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4323
2Roxatidine Acetate Hydrochloride For Injection335
3Levofloxacin Tablets327
4Tranexamic Acid Injection3111
5Duloxetine Hydrochloride Enteric Capsules314
6Oseltamivir Phosphate Capsules3139
7Lidocaine and Prilocaine Cream2224
8Sodium Hyaluronate Eye Drops2230
9Elagolix Tablets212
10Acetaminophen Injection211

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Jun Yuan Pharma Co., Ltd. romanized16100
2Guangxi Yu Yuan Pharma Co., Ltd. romanized1290
3Pfizer Inc.630
4Chongqing Qian Fang Drug Research Co., Ltd. romanized540
5Sichuan Kelun Pharmaceutical Co., Ltd.532
6Rui Yang Pharmaceutical Co., Ltd. romanized522
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized440
8Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized434
9Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized430
10Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized430

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

95 this week

AcceptedDrugApplicants
2023/02/23Import · Class 3.1 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSL2300040 Janssen-Cilag International NV; Johnson &Johnson(China)Investment Ltd.
2023/02/23Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2300625 Shanxi Yuan Yang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2023/02/23Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2300622 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2023/02/23Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2300617 Hangzhou He Kang Pharma Co., Ltd. romanized
2023/02/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2300615 Henan Lan Tu Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/02/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2300614 Henan Lan Tu Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/02/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300152 Suzhou Tuo Hua Bio Technology Co., Ltd. romanized
2023/02/23New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2300151 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 1 NWRD06裸质粒DNA注射液 · No verified English nameCXSL2300150 Nuo Wei Technology (Tai Zhou) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized
2023/02/23New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2300149 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2300148 Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/02/23New drug · Class 1 QR052107B片 · No verified English nameCXHL2300247 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/02/23New drug · Class 1 QR052107B片 · No verified English nameCXHL2300246 Wuhan Lang Lai Technology Development Co., Ltd. romanized
2023/02/23New drug · Class 2.3 复方果糖电解质注射液 · No verified English nameCXHL2300245 Shanghai Zhi Zhen Bio Technology Co., Ltd. romanized
2023/02/23New drug · Class 2.2 HF158K1 · No verified English nameCXHL2300244 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2023/02/23New drug · Class 1 DN020198片 · No verified English nameCXHL2300243 Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized
2023/02/23New drug · Class 1 DN020198片 · No verified English nameCXHL2300242 Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized
2023/02/22Import · Class 3.1 安纳白介素注射液(预充式) · No verified English nameJXSS2300017 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2023/02/22Import · Class 2.2 RO7198574 · No verified English nameJXSL2300039 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/02/22Import · Class 2.2 RO7198574 · No verified English nameJXSL2300038 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/02/22Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2300032 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2023/02/22Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2300611 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2023/02/22Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2300610 Te Feng Pharmaceutical Co., Ltd. romanized
2023/02/22Generic · Class 3 Acetaminophen InjectionCYHS2300609 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/02/22Generic · Class 3 Acetaminophen InjectionCYHS2300608 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/02/22New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300147 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/02/22New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSL2300146 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2023/02/22New drug · Class 3.3 GLR1027注射液 · No verified English nameCXSL2300145 Gan Li Pharma Co., Ltd. romanized
2023/02/22New drug · Class 1 CTS2190胶囊 · No verified English nameCXHL2300241 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized
2023/02/22New drug · Class 1 CTS2190胶囊 · No verified English nameCXHL2300240 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized

65 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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