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
- 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 type | Filings |
|---|---|
| Supplement | 303 |
| New drug | 84 |
| Generic | 78 |
| Import | 45 |
| Import re-registration | 16 |
| Unspecified | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 284 |
| TCM | 148 |
| Therapeutic biologic | 95 |
| Biologic | 11 |
| Prophylactic biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Crisaborole Ointment | 3 | 2 | 26 |
| 2 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 3 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 2 | 22 |
| 4 | 丙泊酚乳状注射液 · No verified English name | 2 | 1 | 3 |
| 5 | Paliperidone Extend-release Tablets | 2 | 1 | 2 |
| 6 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 7 | Telmisartan Tablets | 2 | 1 | 4 |
| 8 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 9 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
| 10 | Minocycline Hydrochloride Capsules | 2 | 1 | 19 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 63 | 49 | 0 |
| 2 | AstraZeneca AB | 15 | 7 | 0 |
| 3 | Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized | 10 | 6 | 0 |
| 4 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 9 | 5 | 0 |
| 5 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 7 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 9 | Pfizer Inc. | 6 | 2 | 0 |
| 10 | Eli Lilly and Company | 6 | 1 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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