YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 621 drug applications between 9 October 2026 and 15 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 110, covering 71 drug names.
2026/10/09 – 2026/10/15
- New acceptances this week
- 621
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 547
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
621filings, 110 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 313 |
| New drug | 132 |
| Generic | 110 |
| Import | 29 |
| Unspecified | 19 |
| Import re-registration | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 332 |
| TCM | 161 |
| Therapeutic biologic | 119 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 6 | 3 | 55 |
| 2 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Ketoprofen Patches | 4 | 2 | 7 |
| 5 | Allopurinol Tablets | 3 | 2 | 4 |
| 6 | Brivaracetam Tablets | 3 | 2 | 19 |
| 7 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 8 | Dihydrocodeine Tartrate Sustained Realese Tablets | 3 | 1 | 3 |
| 9 | Mupirocin Ointment | 2 | 2 | 30 |
| 10 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 17 |
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
359 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 9 | 2 | 0 |
| 2 | Dong E E Jiao Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | N. V. Organon | 8 | 1 | 0 |
| 5 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 7 | Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 9 | AbbVie Inc. | 6 | 2 | 0 |
| 10 | Upjohn Manufacturing Ireland Unlimited 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
206 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/15Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHS2602548 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2026/10/15New drug · Class 3.1 | 芍药甘草汤颗粒 · No verified English nameCXZS2600054 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2026/10/15New drug · Class 1.1 | 金菊消痤颗粒 · No verified English nameCXZL2600100 | Chongqing Xi Er An Pharma Co., Ltd. romanized |
| 2026/10/15New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2600165 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 3.3 | 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2600164 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | DS001注射用冻干粉针 · No verified English nameCXSL2601134 | Hangzhou Da Mai Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | HS-20169注射液 · No verified English nameCXSL2601133 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | 注射用MCLA-129 · No verified English nameCXSL2601132 | Bei Da Pharma Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | 注射用BGB-B2033 · No verified English nameCXSL2601131 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | AI-081注射液 · No verified English nameCXSL2601130 | Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | AI-081注射液 · No verified English nameCXSL2601129 | Nanjing Ang Ke Mian Yi Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | LY-M001 注射液 · No verified English nameCXSL2601128 | Ling Yi (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | RH125注射液 · No verified English nameCXSL2601127 | Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1.4 | 31价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2601126 | Shandong Kun Li Biopharmaceutical Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | 注射用BC602 · No verified English nameCXSL2601125 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2601293 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2601292 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | BPI-572270胶囊 · No verified English nameCXHL2601291 | Hangzhou Jing Yao Bio Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | IN10018片 · No verified English nameCXHL2601290 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | IN10018片 · No verified English nameCXHL2601289 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | ART104注射液 · No verified English nameCXHL2601288 | Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | FY105注射液 · No verified English nameCXHL2601287 | Beijing Foyou Pharma CO.,LTD |
| 2026/10/15New drug · Class 1 | TLL-041片 · No verified English nameCXHL2601286 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | TLL-041片 · No verified English nameCXHL2601285 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | YH601软膏 · No verified English nameCXHL2601284 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/15New drug · Class 1 | YH601软膏 · No verified English nameCXHL2601283 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/14Import · Class 2.2 | 来瑞奇珠单抗注射液(皮下注射) · No verified English nameJXSS2600095 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/10/14Generic · Class 3 | Fexofenadine Hydrochloride Oral SuspensionCYHS2602547 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2026/10/14Generic · Class 3 | Ketoprofen PatchesCYHS2602542 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2026/10/14Generic · Class 3 | Ketoprofen PatchesCYHS2602541 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
176 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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