YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 295 drug applications between 10 November 2022 and 16 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 53 drug names.
2022/11/10 – 2022/11/16
- New acceptances this week
- 295
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 0
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
295filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 73 |
| New drug | 31 |
| Import | 15 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 215 |
| TCM | 49 |
| Therapeutic biologic | 30 |
| Prophylactic biologic | 1 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | Pregabalin Capsules | 3 | 1 | 12 |
| 3 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 4 | Lidocaine Hydrochloride Injection | 3 | 1 | 6 |
| 5 | Fesoterodine Fumarate Prolonged-Release Tablets | 2 | 1 | 0 |
| 6 | Hydrocodone Bitartrate and Ibuprofen Tablets | 2 | 1 | 0 |
| 7 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 8 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 9 | Nicorandil for Injection | 2 | 1 | 1 |
| 10 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
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
170 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 5 | Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | UCB Pharma SA | 5 | 2 | 0 |
| 7 | Xian Sheng Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 8 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Yan Tai Dong Cheng Da Yang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 1 |
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
67 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/16Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSS2200036 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2022/11/16Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSS2200035 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2022/11/16Import · Class 1 | CG0070注射液 · No verified English nameJXSL2200201 | CG Oncology Inc.; Lepu Biopharma Co. Ltd. |
| 2022/11/16Import · Class 1 | ARV-471(PF-07850327 )片 · No verified English nameJXHL2200338 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2022/11/16Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2201995 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2022/11/16Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2201994 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2022/11/16Generic · Class 3 | 水溶性黄体酮注射液 · No verified English nameCYHL2200104 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/11/16New drug · Class 1.1 | 芍药舒筋片 · No verified English nameCXZS2200015 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized; Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized |
| 2022/11/16New drug · Class 1.1 | 双根口服液 · No verified English nameCXZL2200051 | Zhongguo Ren Min Jie Fang Jun Zong Hospital Di Wu Yi Xue Center romanized |
| 2022/11/16New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200576 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2022/11/16New drug · Class 1 | PD-1基因定制活化T细胞注射液 · No verified English nameCXSL2200575 | Anhui Ke Dun Bio Technology Co., Ltd. romanized |
| 2022/11/16New drug · Class 1 | HV-101注射液 · No verified English nameCXSL2200574 | Hangzhou Hou Wu Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/16New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2200901 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2022/11/15Import · Class 1 | PF-06821497片 · No verified English nameJXHL2200336 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/11/15Import · Class 1 | PF-06821497片 · No verified English nameJXHL2200335 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/11/15Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2201992 | Tianjin Jin Yao Group Hubei Tian Yao Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2022/11/15Generic · Class 3 | Famciclovir TabletsCYHS2201981 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/11/15Generic · Class 3 | 6-[18F]Fluoro-L-DOPA InjectionCYHL2200103 | Jiangsu Hua Yi Technology Co., Ltd. romanized |
| 2022/11/15New drug · Class 1.1 | 藿夏感冒颗粒 · No verified English nameCXZL2200050 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2022/11/15New drug · Class 2.2 | 注射用重组人TNK组织型纤溶酶原激活剂 · No verified English nameCXSS2200090 | Shi Yao Group Ming Fu Le Pharma (Guangzhou) Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | BR108注射液 · No verified English nameCXSL2200573 | Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/11/15New drug · Class 2.2 | 右布洛芬缓控释双层片 · No verified English nameCXHL2200900 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | 注射用顺眠肽 · No verified English nameCXHL2200899 | Guangzhou Liu Shun Bio Technology Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | ZN-A-1041肠溶胶囊 · No verified English nameCXHL2200898 | Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200897 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | 甲磺酸贝福替尼胶囊 · No verified English nameCXHL2200896 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/15New drug · Class 1 | SIM0270胶囊 · No verified English nameCXHL2200895 | Xian Sheng Pharma Co., Ltd. romanized |
| 2022/11/14Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201979 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2022/11/14Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201978 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2022/11/14Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201977 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
37 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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