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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 306 drug applications between 13 July 2022 and 19 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.

2022/07/13 – 2022/07/19

Period
2022/07/13 to 2022/07/19, 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
306
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
3

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

306filings, 51 of them generic

By application type

Application typeFilings
Supplement166
Generic51
Import40
New drug34
Import re-registration8
Unspecified6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug232
TCM36
Therapeutic biologic34
Biologic2
Prophylactic biologic2

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Ruxolitinib Phosphate Tablets3127
3Phloroglucinol Injection222
4Perampanel Tablets212
5头孢丙烯干混悬剂 · No verified English name212
6Doxercalciferol Injection211
7Aminophylline Injection213
8Dexmedetomidine Hydrochloride Injection210
9Oxytocin Injection218
10Citicoline Sodium Injection213

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

167 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang No.4 Pharmaceutical Co., Ltd.1343
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized10100
3AstraZeneca AB840
4Shang Qiu Shi Jin Ma Pharma Co., Ltd. romanized770
5Sichuan Guo Rui Pharma Co., Ltd. romanized720
6Eli Lilly and Company610
7Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
8Qingdao Rui Nai Medical Technology Co., Ltd. romanized555
9Novartis Europharm Limited530
10Novartis Pharma AG520

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

101 this week

AcceptedDrugApplicants
2022/07/19Import · Class 3.1 奥马珠单抗注射液 · No verified English nameJXSS2200025 Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd.
2022/07/19Import · Class 3.1 安纳白介素注射液(预充式) · No verified English nameJXSS2200024 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2022/07/19Import · Class 2.2 Efgartigimod注射液 · No verified English nameJXSL2200125 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2022/07/19Import · Class 1 RO7082859 · No verified English nameJXSL2200124 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/19Import · Class 1 AZD5718片 · No verified English nameJXHL2200204 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd
2022/07/19Import · Class 2.4 Linzagolix片 · No verified English nameJXHL2200203 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/07/19Import · Class 2.4 Linzagolix片 · No verified English nameJXHL2200202 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/07/19Generic · Class 3 Citicoline Sodium InjectionCYHS2201104 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2022/07/19Generic · Class 3 Citicoline Sodium InjectionCYHS2201103 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2022/07/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2201102 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/07/19Generic · Class 3 Butorphanol Tartrate InjectionCYHS2201101 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/07/19Generic · Class 3 Ornidazole TabletsCYHS2201100 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2022/07/19Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2201099 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2022/07/19Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2201098 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2022/07/19New drug · Class 1.1 抗敏镇咳颗粒 · No verified English nameCXZL2200033 Tianjin Le Dun Zhong Yao Co., Ltd. romanized
2022/07/19New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSS2200068 Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized
2022/07/19New drug · Class 1 GC101腺相关病毒注射液 · No verified English nameCXSL2200324 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/07/19New drug · Class 2.4 注射用艾普拉唑钠 · No verified English nameCXHS2200040 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/07/19New drug · Class 2.4 奥雷巴替尼片 · No verified English nameCXHS2200039 Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2022/07/19New drug · Class 1 LW402片 · No verified English nameCXHL2200516 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2022/07/19New drug · Class 1 LW402片 · No verified English nameCXHL2200515 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2022/07/19New drug · Class 2.2; 2.4 XYP-001 · No verified English nameCXHL2200508 Health Yuan Pharma Group Co., Ltd. romanized
2022/07/19New drug · Class 1 LW402片 · No verified English nameCXHL2200492 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2022/07/18Import · Class 3.1 依库珠单抗注射液 · No verified English nameJXSS2200023 Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd
2022/07/18Import · Class 1 Nolasiban分散片 · No verified English nameJXHL2200201 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Import · Class 1 Nolasiban分散片 · No verified English nameJXHL2200200 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Generic · Class 3 Magnesium Sulfate InjectionCYHS2201096 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/07/18Generic · Class 3 Beraprost Sodium TabletsCYHS2201090 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2022/07/18Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2201088 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/07/18Generic · Class 3 Acotiamide Hydrochloride TabletsCYHS2201087 Beijing Ya Bao Bio Pharma Co., Ltd. romanized

71 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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