YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 587 drug applications between 17 September 2026 and 23 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.
2026/09/17 – 2026/09/23
- New acceptances this week
- 587
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 483
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
587filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 321 |
| New drug | 100 |
| Generic | 93 |
| Import | 36 |
| Unspecified | 19 |
| Import re-registration | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 304 |
| TCM | 164 |
| Therapeutic biologic | 106 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 4 | 1 | 27 |
| 2 | 盐酸西替利嗪滴眼液 · No verified English name | 3 | 3 | 3 |
| 3 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 4 | Brimonidine Tartrate Eye Drops | 3 | 3 | 4 |
| 5 | Baricitinib Tablets | 3 | 2 | 32 |
| 6 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 7 | Mupirocin Ointment | 3 | 1 | 30 |
| 8 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 9 | Fruquintinib Capsules | 2 | 1 | 4 |
| 10 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
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
338 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 12 | 1 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 11 | 2 | 0 |
| 3 | Janssen-Cilag International NV | 10 | 3 | 0 |
| 4 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 5 | Bayer Vital GmbH | 9 | 1 | 0 |
| 6 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 7 | 2 | 0 |
| 7 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Xian Wan Long Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Jiangsu Lian Huan Zhong Yao Co., Ltd. romanized | 5 | 3 | 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
148 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/23Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2600259 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600258 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
| 2026/09/23Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600257 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
| 2026/09/23Import · Class 2.4 | 塞普替尼片 · No verified English nameJXHS2600121 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 2.4 | 塞普替尼片 · No verified English nameJXHS2600120 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 2.4 | 塞普替尼片 · No verified English nameJXHS2600119 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 2.4 | 塞普替尼片 · No verified English nameJXHS2600118 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 1 | BI 3034701注射液 · No verified English nameJXHL2600416 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/09/23Import · Class 1 | BI 3034701注射液 · No verified English nameJXHL2600415 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/09/23Import · Class 1 | BI 3034701注射液 · No verified English nameJXHL2600414 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/09/23Import · Class 1 | BI 3034701注射液 · No verified English nameJXHL2600413 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/09/23Import · Class 1 | BI 3034701注射液 · No verified English nameJXHL2600412 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/09/23Generic · Class 3 | Cefazolin Sodium for InjectionCYHS2602400 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2026/09/23Generic · Class 3 | Potassium Aspartate InjectionCYHS2602398 | Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2026/09/23Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602394 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/09/23Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2602391 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized |
| 2026/09/23New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2600052 | Jiangxi Yao Dou Zhang Shu Pharmaceutical Co., Ltd. romanized |
| 2026/09/23New drug · Class 1.1 | 巴芪柔肝颗粒 · No verified English nameCXZL2600094 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized; Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | 注射用HLX49 · No verified English nameCXSL2601056 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | RG002-02注射液 · No verified English nameCXSL2601055 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2026/09/23New drug · Class 3.3 | 依柯胰岛素注射液 · No verified English nameCXSL2601054 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2026/09/23New drug · Class 1.1 | 猴痘mRNA疫苗 · No verified English nameCXSL2601053 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | 注射用Efimosfermin alfa · No verified English nameCXSL2601052 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2026/09/23New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2600136 | Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized; Xiamen En Cheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/23New drug · Class 2.3 | BTP4106 · No verified English nameCXHL2601199 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | OST11098片 · No verified English nameCXHL2601198 | Hefei Sheng Rui Ze Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | OST11098片 · No verified English nameCXHL2601197 | Hefei Sheng Rui Ze Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/23New drug · Class 1 | ASP5834注射液 · No verified English nameCXHL2601196 | An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/09/23New drug · Class 2.4 | 氨酚羟考酮缓释片 · No verified English nameCXHL2601195 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2026/09/22Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2600256 | Merck Sharp & Dohme LLC; Name not romanized |
118 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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