YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 146 drug applications between 17 September 2021 and 23 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 14 drug names.

2021/09/17 – 2021/09/23

Period
2021/09/17 to 2021/09/23, 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
146
Drugs with new generic filings (by drug name, de-duplicated)
14
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

146filings, 21 of them generic

By application type

Application typeFilings
Supplement83
Generic21
New drug19
Unspecified12
Import6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug104
TCM23
Therapeutic biologic13
Biologic4
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

14 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension4214
2Sacubitril Valsartan Sodium Tablets3170
3Urapidil Hydrochloride Injection216
4Felodipine Sustained Release Tablets211
5Tenofovir alafenamide Fumarate Tablets110
6Levetiracetam Oral Solution113
7Levofloxacin Tablets117
8Tranexamic Acid Injection1111
9Tedizolid Phosphate For Injection113
10Bromfenac Sodium Eye Drops117

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

84 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sai Ling Pharma Technology Group Co., Ltd. romanized14130
2Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized12100
3Sun Pharmaceutical Industries Ltd.520
4Bristol-Myers Squibb Pharma EEIG510
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized330
6AstraZeneca AB320
7Pfizer Inc.310
8Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.313
9Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized310
10PT. Bio Farma220

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

24 this week

AcceptedDrugApplicants
2021/09/23Import · Class 3.1 依奇珠单抗注射液 · No verified English nameJXSS2101023 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/09/23Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101767 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2021/09/23New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101340 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101339 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101338 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 注射用SHR-1802 · No verified English nameCXSL2101337 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101336 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101494 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101493 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/22New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2101031 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/09/18Import · Class 1.1 预防性呼吸道合胞病毒疫苗 · No verified English nameJXSL2101111 Janssen Vaccines & Prevention B.V.; Johnson & Johnson (China) Investment Ltd.
2021/09/18Generic · Class 3 Tranexamic Acid InjectionCYHS2101760 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/09/18New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101335 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/18New drug · Class 1 YY-20394片 · No verified English nameCXHL2101490 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/09/18New drug · Class 1 ABM-1310胶囊 · No verified English nameCXHL2101489 Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/09/18New drug · Class 1 ABM-1310胶囊 · No verified English nameCXHL2101488 Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/09/17Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2101180 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/09/17New drug · Class 2.2 注射用重组葡激酶 · No verified English nameCXSL2101333 Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 SHR-2002注射液 · No verified English nameCXSL2101331 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/17New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2101326 Shanghai Rong Sheng Bio Pharma Co., Ltd. romanized
2021/09/17New drug · Class 2.2; 2.3 替格瑞洛阿司匹林胶囊 · No verified English nameCXHL2101487 Le Pu Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 注射用APG-1252 · No verified English nameCXHL2101486 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 富马酸BGB-10188胶囊 · No verified English nameCXHL2101482 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/09/17New drug · Class 1 富马酸BGB-10188胶囊 · No verified English nameCXHL2101481 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.