YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 258 drug applications between 20 February 2021 and 26 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 31 drug names.
2021/02/20 – 2021/02/26
- New acceptances this week
- 258
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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
258filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| New drug | 44 |
| Generic | 43 |
| Import | 23 |
| Unspecified | 15 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 199 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 11 |
| TCM | 6 |
| 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 4 | 2 | 0 |
| 2 | Torsemide Injection | 3 | 2 | 1 |
| 3 | Fondaparinux Sodium Injection | 2 | 2 | 1 |
| 4 | Olanzapine Orally Disintegrating Tablets | 2 | 1 | 0 |
| 5 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 6 | Pregabalin Capsules | 2 | 1 | 12 |
| 7 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 8 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 1 |
| 9 | 色甘酸钠颗粒 · No verified English name | 2 | 1 | 0 |
| 10 | 丙酸氟替卡松吸入粉雾剂 · No verified English name | 1 | 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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 5 | 1 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 3 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 5 | 3 | 2 |
| 5 | Hebei Tian Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Fertin Pharma A/S | 4 | 1 | 0 |
| 7 | GlaxoSmithKline Biologicals SA | 4 | 1 | 0 |
| 8 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 9 | Novo Nordisk A/S | 4 | 1 | 0 |
| 10 | TEIJIN PHARMA LIMITED | 4 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/26Import · Class 1 | Mim8 · No verified English nameJXSL2100032 | Novo Nordisk A/S |
| 2021/02/26Import · Class 1 | Mim8 · No verified English nameJXSL2100031 | Novo Nordisk A/S |
| 2021/02/26Import · Class 1 | ALG-000184片 · No verified English nameJXHL2100057 | Aligos Therapeutics Inc. |
| 2021/02/26Import · Class 1 | ALG-000184片 · No verified English nameJXHL2100056 | Aligos Therapeutics Inc. |
| 2021/02/26Import · Class 1 | ALG-000184片 · No verified English nameJXHL2100055 | Aligos Therapeutics Inc. |
| 2021/02/26New drug · Class 3.3 | 门冬胰岛素注射液 · No verified English nameCXSS2100025 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2021/02/26New drug · Class 1 | 重组抗PD-L1和TGF-β双特异性抗体注射液 · No verified English nameCXSL2100073 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2021/02/26New drug · Class 1.2 | 重组三价轮状病毒亚单位疫苗 · No verified English nameCXSL2100072 | Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized |
| 2021/02/26New drug · Class 1 | HRS8807片 · No verified English nameCXHL2100139 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/26New drug · Class 1 | HRS8807片 · No verified English nameCXHL2100138 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/25Import · Class 3.1 | 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100018 | GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA |
| 2021/02/25Import · Class 3.1 | 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100017 | GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA |
| 2021/02/25Import · Class 1 | Mim8 · No verified English nameJXSL2100034 | Novo Nordisk A/S |
| 2021/02/25Import · Class 1 | Mim8 · No verified English nameJXSL2100033 | Novo Nordisk A/S |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100063 | Eli Lilly and Company |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100062 | Eli Lilly and Company |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100061 | Eli Lilly and Company |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100060 | Eli Lilly and Company |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100059 | Eli Lilly and Company |
| 2021/02/25Import · Class 1 | Tirzepatide注射液 · No verified English nameJXHL2100058 | Eli Lilly and Company |
| 2021/02/25Generic · Class 3 | Dantrolene Sodium CapsulesCYHS2100222 | Wuhan Heng Xin Yuan Pharma Co., Ltd. romanized |
| 2021/02/25New drug · Class 1 | BJ-001注射液 · No verified English nameCXSL2100071 | Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2021/02/25New drug · Class 1 | BAT6026注射液 · No verified English nameCXSL2100070 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/02/25New drug · Class 1 | 注射用SSGJ-612 · No verified English nameCXSL2100069 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/02/25New drug · Class 2.2 | 盐酸美沙酮泡腾片 · No verified English nameCXHS2100007 | Qinghai Pharmaceutical Co., Ltd. romanized |
| 2021/02/25New drug · Class 2.2 | 盐酸美沙酮泡腾片 · No verified English nameCXHS2100006 | Qinghai Pharmaceutical Co., Ltd. romanized |
| 2021/02/25New drug · Class 2.2 | 盐酸美沙酮泡腾片 · No verified English nameCXHS2100005 | Qinghai Pharmaceutical Co., Ltd. romanized |
| 2021/02/25New drug · Class 1 | 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2100137 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/02/25New drug · Class 1 | 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2100136 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/02/25New drug · Class 2.4 | Tirofiban Hydrochloride And Sodium Chloride InjectionCXHL2100135 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
46 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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