YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 314 drug applications between 8 December 2021 and 14 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.
2021/12/08 – 2021/12/14
- New acceptances this week
- 314
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
314filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| New drug | 51 |
| Generic | 49 |
| Import | 14 |
| Import re-registration | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 218 |
| TCM | 49 |
| Therapeutic biologic | 44 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Tofacitinib Citrate Tablets | 2 | 2 | 1 |
| 4 | Vildagliptin Tablets | 2 | 2 | 0 |
| 5 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 1 | 0 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 8 | Carbocisteine Oral Solution | 2 | 1 | 6 |
| 9 | Febuxostat Tablets | 2 | 1 | 12 |
| 10 | Clotrimazole Vaginal Tablets | 1 | 1 | 3 |
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
159 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 22 | 20 | 0 |
| 2 | Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Haerbin Tian Mei Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 4 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 9 | 4 | 5 |
| 5 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 6 | Janssen-Cilag International NV | 8 | 2 | 0 |
| 7 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 8 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Ha Yao Group Zhong Yao Er Factory romanized | 5 | 4 | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/14Import · Class 1 | DS-1062a · No verified English nameJXSL2101147 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/12/14Import · Class 1 | 盐酸PQ912片 · No verified English nameJXHL2101271 | Vivoryon Therapeutics N.V.; Jiangsu Simcere Pharmaceutical Co. Ltd. |
| 2021/12/14Import · Class 1 | 盐酸PQ912片 · No verified English nameJXHL2101270 | Vivoryon Therapeutics N.V.; Jiangsu Simcere Pharmaceutical Co. Ltd. |
| 2021/12/14Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2102197 | Jilin Sheng Li Hua Pharmaceutical Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Bepotastine Besilate Orally Disintegrating TabletsCYHS2102189 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Bei De Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHL2101055 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHL2101054 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHL2101053 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHL2101052 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Desonide CreamCYHL2101051 | Fu Yuan Pharma Co., Ltd. romanized |
| 2021/12/14Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2101048 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/14New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2101058 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/14New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2101057 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | HBM9378(SKB378) 注射液 · No verified English nameCXSL2101485 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | 注射用IMM01 · No verified English nameCXSL2101484 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | Zilovertamab vedotin注射液 · No verified English nameCXSL2101483 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2101480 | Qilu Pharmaceutical Co., Ltd. |
| 2021/12/14New drug · Class 1 | YH003注射液 · No verified English nameCXSL2101479 | Name not romanized |
| 2021/12/14New drug · Class 1 | FKC889 · No verified English nameCXSL2101478 | Fu Xing Kai Te Bio Technology Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101476 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/12/14New drug · Class 2.2; 2.4 | 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHL2101755 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14New drug · Class 2.2 | 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHL2101753 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | TQH3910片 · No verified English nameCXHL2101751 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/12/14New drug · Class 1 | TQH3910片 · No verified English nameCXHL2101750 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/12/14New drug · Class 1 | HL-085胶囊 · No verified English nameCXHL2101747 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | HL-085胶囊 · No verified English nameCXHL2101746 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | HL-085胶囊 · No verified English nameCXHL2101745 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | HL-085胶囊 · No verified English nameCXHL2101744 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | ORIN1001片 · No verified English nameCXHL2101743 | Fu Xing Hong Chuang (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/14New drug · Class 1 | HS-10370片 · No verified English nameCXHL2101738 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
41 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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