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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 519 drug applications between 10 February 2026 and 16 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 66 drug names.

2026/02/10 – 2026/02/16

Period
2026/02/10 to 2026/02/16, 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
519
Drugs with new generic filings (by drug name, de-duplicated)
66
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

519filings, 86 of them generic

By application type

Application typeFilings
Supplement254
New drug101
Generic86
Import44
Unspecified17
Import re-registration17

By drug type

Drug typeFilings
Chemical drug306
Therapeutic biologic110
TCM87
Biologic11
Prophylactic biologic5

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Crisaborole Ointment3226
2注射用磷酸左奥硝唑酯二钠 · No verified English name2222
3Sodium Hyaluronate Eye Drops2230
4丙泊酚乳状注射液 · No verified English name213
5复方氨基酸注射液(18AA-VII) · No verified English name213
6Paliperidone Extend-release Tablets212
7帕拉米韦氯化钠注射液 · No verified English name2117
8Telmisartan Tablets214
9Sacubitril Valsartan Sodium Tablets2170
10Dexmethylphenidate Hydrochloride Exended-release Capsules212

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

307 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB1250
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized950
3Jiangxi Pu Li Er Pharma Co., Ltd. romanized880
4Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized850
5Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized760
6Janssen Research & Development LLC620
7Pfizer Inc.620
8Eli Lilly and Company610
9F. Hoffmann-La Roche Ltd610
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized540

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

168 this week

AcceptedDrugApplicants
2026/02/15New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600232 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/02/15New drug · Class 1 SIR4156片 · No verified English nameCXHL2600208 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2026/02/15New drug · Class 2.2 氨酚羟考酮缓释片 · No verified English nameCXHL2600207 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2026/02/14Import · Class 3.1 注射用索特西普 · No verified English nameJXSS2600011 Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd.
2026/02/14Import · Class 3.1 注射用索特西普 · No verified English nameJXSS2600010 Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd.
2026/02/14Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600488 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2026/02/14Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600486 Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized
2026/02/14Generic · Class 3 Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600482 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/02/14Generic · Class 3 Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600481 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/02/14Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2600480 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/02/14New drug · Class 1 达尔扑拜单抗注射液 · No verified English nameCXSS2600022 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/02/14New drug · Class 1 芮特韦拜单抗注射液 · No verified English nameCXSS2600021 Zhuhai Tai Nuo Mai Bo Pharmaceutical Co., Ltd. romanized
2026/02/14New drug · Class 1 库莱韦单抗注射液 · No verified English nameCXSS2600020 Rui Yang (Shandong) Biopharmaceutical Co., Ltd. romanized
2026/02/14New drug · Class 1 YB1-X7注射液 · No verified English nameCXSL2600233 Shao Xing Shan Wei Te Bio Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600231 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/14New drug · Class 1 SHR-3079注射液 · No verified English nameCXSL2600230 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/14New drug · Class 2.1 人胰岛素肠溶胶囊 · No verified English nameCXSL2600229 Hefei Tian Hui Bio Technology Co., Ltd. romanized
2026/02/14New drug · Class 2.1 人胰岛素肠溶胶囊 · No verified English nameCXSL2600228 Hefei Tian Hui Bio Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600227 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600226 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600225 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2600223 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/14New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2600222 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/14New drug · Class 1 注射用DEC003M · No verified English nameCXSL2600221 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 注射用SIBP-A17 · No verified English nameCXSL2600220 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/02/14New drug · Class 1 注射用TUL108 · No verified English nameCXHL2600206 Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized
2026/02/14New drug · Class 2.2 NH601缓释胶囊 · No verified English nameCXHL2600205 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/14New drug · Class 2.2 NH601缓释胶囊 · No verified English nameCXHL2600204 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/14New drug · Class 2.2 NH601缓释胶囊 · No verified English nameCXHL2600203 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/14New drug · Class 1 VV261片 · No verified English nameCXHL2600202 Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized

138 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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