YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 17 January 2024 and 23 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 62 drug names.

2024/01/17 – 2024/01/23

Period
2024/01/17 to 2024/01/23, 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
320
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
2

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

320filings, 77 of them generic

By application type

Application typeFilings
Supplement159
Generic77
New drug56
Import19
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug206
TCM61
Therapeutic biologic47
Prophylactic biologic4
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

62 drugs with new generic filings; top 10 listed

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Yong He Tang Pharma Co., Ltd. romanized16160
2Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized1090
3Boehringer Ingelheim International GmbH1040
4Jin He Zang Yao Co., Ltd. romanized770
5Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized650
6Jilin Wu Tai Gan Kang Pharma Co., Ltd. romanized550
7Guangdong Ke Lun Pharma Co., Ltd. romanized510
8Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized440
9Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440

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

108 this week

AcceptedDrugApplicants
2024/01/23Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSS2400001 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/01/23Import · Class 1 阿塞西普 · No verified English nameJXSL2400022 Vera Therapeutics Inc.; Tianjin Happy Life Technology Co. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400023 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400022 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400021 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Generic · Class 3 Bumetanide InjectionCYHS2400308 Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/23Generic · Class 3 Sodium Thiosulfate InjectionCYHS2400306 Nanjing Hai Chen Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2024/01/23Generic · Class 3 Urapidil Sustained-release CapsulesCYHS2400304 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/01/23Generic · Class 3 Meloxicam injectionCYHS2400303 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2024/01/23Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2400302 Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2024/01/23Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2400301 Shenzhen Shi Rui Hua Pharmaceutical Technology Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized
2024/01/23New drug · Class 2.3 西帕依固龈液 · No verified English nameCXZL2400006 Xin Qi Kang Pharma Co., Ltd. romanized
2024/01/23New drug · Class 1 SHR-1139注射液 · No verified English nameCXSL2400054 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/23New drug · Class 2.2 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2400053 Beijing Min Hai Bio Technology Co., Ltd. romanized
2024/01/23New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2400052 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/01/23New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400051 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/01/23New drug · Class 1 SYH2043片 · No verified English nameCXHL2400099 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/01/23New drug · Class 1 SYH2043片 · No verified English nameCXHL2400098 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/01/23New drug · Class 1 HRS2398缓释片 · No verified English nameCXHL2400097 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/23New drug · Class 2.2 KPC-149口服溶液 · No verified English nameCXHL2400096 Kun Yao Group Co., Ltd. romanized
2024/01/23New drug · Class 2.2 KPC-149口服溶液 · No verified English nameCXHL2400095 Kun Yao Group Co., Ltd. romanized
2024/01/23New drug · Class 2.3 BCM863片 · No verified English nameCXHL2400094 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/01/22Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400291 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/01/22New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2400050 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2400049 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2400048 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2400093 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2400092 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 1 HRS8807片 · No verified English nameCXHL2400091 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/01/22New drug · Class 1 HRS8807片 · No verified English nameCXHL2400090 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized

78 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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