YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 540 drug applications between 7 February 2026 and 13 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 60 drug names.

2026/02/07 – 2026/02/13

Period
2026/02/07 to 2026/02/13, 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
540
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
142

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

540filings, 78 of them generic

By application type

Application typeFilings
Supplement303
New drug84
Generic78
Import45
Import re-registration16
Unspecified14

By drug type

Drug typeFilings
Chemical drug284
TCM148
Therapeutic biologic95
Biologic11
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Crisaborole Ointment3226
2Levofloxacin and Sodium Chloride Injection3114
3注射用磷酸左奥硝唑酯二钠 · No verified English name2222
4丙泊酚乳状注射液 · No verified English name213
5Paliperidone Extend-release Tablets212
6帕拉米韦氯化钠注射液 · No verified English name2117
7Telmisartan Tablets214
8Sacubitril Valsartan Sodium Tablets2170
9Promethazine Hydrochloride Injection2111
10Minocycline Hydrochloride Capsules2119

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

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized63490
2AstraZeneca AB1570
3Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized1060
4Ha Yao Group Bio Gong Cheng Co., Ltd. romanized950
5Jiangxi Pu Li Er Pharma Co., Ltd. romanized770
6Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized760
7Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized660
8Janssen Research & Development LLC620
9Pfizer Inc.620
10Eli Lilly and Company610

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

150 this week

AcceptedDrugApplicants
2026/02/13Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2600009 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2026/02/13Import · Class 1 Baxdrostat片 · No verified English nameJXHS2600026 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/02/13Import · Class 1 Baxdrostat片 · No verified English nameJXHS2600025 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600055 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600054 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600053 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600052 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600051 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600049 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600048 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600047 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600046 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600045 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/02/13Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600044 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/02/13Generic · Class 3 Idarubicin Hydrochloride InjectionCYHS2600487 Guangdong Sunho Pharmaceutical Co., Ltd.
2026/02/13Generic · Class 3 Colchicine TabletsCYHS2600467 Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized
2026/02/13Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2600463 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2026/02/13Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2600458 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2026/02/13New drug · Class 1 抗蜂毒血清 · No verified English nameCXSL2600224 Shanghai Sai Lun Bio Technology Co., Ltd. romanized
2026/02/13New drug · Class 1 人源肾祖细胞注射液 · No verified English nameCXSL2600219 Guangzhou Hua Yue Shen Ke Zai Sheng Yi Xue Technology Co., Ltd. romanized
2026/02/13New drug · Class 1 QLS2322注射液 · No verified English nameCXSL2600218 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/02/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600216 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/02/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600215 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/02/13New drug · Class 1 IBR900细胞注射液 · No verified English nameCXSL2600213 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/02/13New drug · Class 2.2 QL2109注射液 · No verified English nameCXSL2600211 Qilu Pharmaceutical Co., Ltd.
2026/02/13New drug · Class 1 注射用QLS4131 · No verified English nameCXSL2600210 Qilu Pharmaceutical Co., Ltd.
2026/02/13New drug · Class 2.2 注射用罗哌卡因微晶 · No verified English nameCXHS2600032 Zhejiang Cui Ze Biopharmaceuticals Co., Ltd. romanized
2026/02/13New drug · Class 1 盐酸莫托咪酯注射液 · No verified English nameCXHS2600031 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2026/02/13New drug · Class 2.2 盐酸氨溴索口溶膜 · No verified English nameCXHS2600030 Hainan Huluwa Pharmaceutical Group Co., Ltd.

120 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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