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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 220 drug applications between 5 October 2024 and 11 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 41 drug names.

2024/10/05 – 2024/10/11

Period
2024/10/05 to 2024/10/11, 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
220
Drugs with new generic filings (by drug name, de-duplicated)
41
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

220filings, 56 of them generic

By application type

Application typeFilings
Supplement98
Generic56
New drug32
Import19
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug149
Therapeutic biologic36
TCM31
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fusidic Acid Cream4215
2Bupivacaine Hydrochloride Injection314
3Iguratimod Tablets2223
4ω-3 Fish Oil Fat Emulsion Injection216
5Piracetam Injection219
6Vonoprazan Fumarate Tablets2160
7Pregabalin Capsules2112
8Sodium Hyaluronate Eye Drops2130
9Vardenafil Hydrochloride Tablets214
10Dopamine Hydrochloride 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

144 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV540
2Merck Sharp & Dohme B.V.530
3Eli Lilly and Company520
4AstraZeneca AB430
5Jenapharm GmbH & Co. KG420
6Pfizer Inc.420
7Bristol-Myers Squibb Pharma EEIG410
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
9Bard Pharmaceuticals Limited330
10Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized330

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

64 this week

AcceptedDrugApplicants
2024/10/11Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2400087 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2024/10/11Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2400086 Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd.
2024/10/11Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400085 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/10/11Import · Class 2.1 埃万妥单抗注射液(皮下注射) · No verified English nameJXSS2400084 Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.
2024/10/11Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2400191 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/10/11Import · Class 2.4 甲磺酸兰泽替尼片 · No verified English nameJXHS2400076 Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd.
2024/10/11Import · Class 1 AZD6234注射液 · No verified English nameJXHL2400243 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/10/11Import · Class 2.4 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400242 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/10/11Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2403381 Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized
2024/10/11Generic · Class 3 Magnesium Sulfate InjectionCYHS2403376 Henan Pu Rui Pharma Co., Ltd. romanized
2024/10/11Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2403372 Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/10/11Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2403371 Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/10/11Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2403370 Hainan Sai Fu Ti Pharmaceuticals Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/10/11Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2403365 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2024/10/11Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403357 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/10/11New drug · Class 1.1 渴脉平颗粒 · No verified English nameCXZL2400065 Beijing Hou Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 注射用ZHB015 · No verified English nameCXSL2400684 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2024/10/11New drug · Class 1 HCB101注射液 · No verified English nameCXSL2400683 Guangzhou Han Ke Bio Co., Ltd. romanized
2024/10/11New drug · Class 3.3 人生长激素注射液 · No verified English nameCXSL2400682 Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized
2024/10/11New drug · Class 1.2 冻干呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400681 Na Mei Xin (Shanghai) Bio Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 SHR2554片 · No verified English nameCXHS2400102 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/10/11New drug · Class 1 SYH2062注射液 · No verified English nameCXHL2401052 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/10/11New drug · Class 1 BPR-30221616注射液 · No verified English nameCXHL2401051 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/10/11New drug · Class 1 BPR-30221616注射液 · No verified English nameCXHL2401050 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/10/11New drug · Class 1 DC10190胶囊 · No verified English nameCXHL2401049 Beijing Shuang He Run Chuang Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 DC10190胶囊 · No verified English nameCXHL2401048 Beijing Shuang He Run Chuang Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 ANS03片 · No verified English nameCXHL2401047 Shenzhen An Shi Bio Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 ANS03片 · No verified English nameCXHL2401046 Shenzhen An Shi Bio Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 BY101921片 · No verified English nameCXHL2401045 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2024/10/11New drug · Class 1 BY101921片 · No verified English nameCXHL2401044 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized

34 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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